Safety and efficacy of everolimus-eluting bioresorbable vascular scaffold for cardiac allograft vasculopathy (CART).

BACKGROUND: Cardiac allograft vasculopathy (CAV) is still the main drawback of heart transplantation (HTx) and percutaneous coronary intervention (PCI) is a palliative measure because of the high incidence of failure. OBJECTIVE: This study aimed to investigate the safety and efficacy of bioresorbable scaffolds (BRSs) as potential novel therapeutic tool for the treatment of coronary stenoses in CAV. METHODS: This is a multicenter, single-arm, prospective, open-label study (CART, NCT02377648), that included patients affected by advanced CAV treated with PCI and second-generation ABSORB BRS (Abbott Vascular). The primary endpoint was the incidence of 12-month angiographic in-segment scaffold restenosis (ISSR). Secondary endpoints were the incidence of major adverse cardiac events (MACEs) at 12- and 36-month follow-up and the incidence of ISSR at 36 months. A paired intracoronary imaging analysis at baseline and follow-up was also performed. RESULTS: Between 2015 and 2017 35 HTx patients were enrolled and treated for 44 coronary lesions with 51 BRSs. The primary endpoint occurred in 13.5% of the lesions (5/37), with a cumulative ISSR rate up to 3 years of 16.2% (6/37). Angiographic lumen loss was 0.40 ± 0.62 mm at 12 months and 0.53 ± 0.57 mm at 36 months. Overall survival rate was 91.4% and 74.3%, and MACEs incidence 14.2% and 31.4% at 12 and 36 months, respectively. At the paired intracoronary imaging analysis, a significant increase of the vessel external elastic membrane area in the treated segment and some progression of CAV proximally to the BRS were detected. CONCLUSIONS: BRS-based PCI for the treatment of CAV is feasible and safe, with an ISSR incidence similar to what reported in retrospective studies with drug-eluting stents.

Outcomes of 10,312 patients treated with everolimus-eluting bioresorbable scaffolds during daily clinical practice - results from the European Absorb Consortium.

OBJECTIVES: To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population. BACKGROUND: Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation. METHODS: The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics. RESULTS: A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST. CONCLUSIONS: The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.

ImpaCt of an Optimal Implantation Strategy on Absorb Long-Term Outcomes: The CIAO Registry.

AIM: To compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique. METHODS AND RESULTS: All patients who received an Absorb between March 2012 and January 2016 were selected from 19 Italian centers databases to assess the impact of an optimal implantation technique (CIAO criteria) on long-term device-oriented composite end-point (DOCE) - including cardiac death (CD), target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) - on its single components and on scaffold thrombosis (ScT). CIAO criteria consist of predilation (balloon/vessel ratio 1:1), correct sizing (BRS/proximal reference vessel diameter -RVD- ratio 0.8-1.2) and high-pressure postdilation with non-compliant (NC) balloon (≥20 atm for balloon/BRS ratio 1:1 or ≥16 atm for a 0.25-0.5 mm oversized balloon). Among the 1.434 patients analyzed, 464 (32.4%) fulfilled all CIAO criteria for every BRS implanted (CIAO 3 group), while 970 (67.6%) did not in at least one of the received BRS (CIAO 0-1-2 group). At 31.0 (interquartile range -IQR- 24.8-38.5) months follow-up, CIAO criteria did not impact on DOCE (8.2% vs. 8.0%, p = 0.92), ID-TLR (6.9% vs. 7.1%, p = 0.72) or ScT (1.9% vs. 1.8%, p = 0.80) in the overall population. At multivariate analysis overall BRS length (p = 0.001), severely calcified lesions (p = 0.03) and absence of CIAO criteria (CIAO 0, p = 0.005) were independent predictors of DOCE in long-term follow-up. CONCLUSION: Our data suggest that strict application of an optimal Absorb implantation technique doesn't improve long-term DOCE or ScT but may mitigate the worse outcome of patients with calcific lesions.

Mitro-aortic fibrosa pseudoaneurysm and concomitant aortic stenosis: How to kill two birds with a stone.

Pseudoaneurysm of mitral-aortic intervalvular fibrosa (P-MAIVF) is a rare acquired malformation of the mitral-aortic intervalvular area. It appears as a pulsatile cavity in the mitral-aortic junction communicating with the left ventricular outflow tract. P-MAIVF has been reported as a complication of aortic and mitral valve surgery, infective endocarditis, and thoracic trauma. It is associated with life-threatening complications. The recommended treatment is surgery, however, conservative therapy is an alternative approach for high-risk patients or when surgical treatment is refused. We describe a successfully exclusion of a P-MAIVF by transapical transcatheter aortic valve implantation in a patient with concomitant severe aortic stenosis.

Correction to: Health-related qualify of life, angina type and coronary artery disease in patients with stable chest pain.

An amendment to this paper has been published and can be accessed via the original article.

Health-related qualify of life, angina type and coronary artery disease in patients with stable chest pain.

BACKGROUND: Health-related quality of life (HRQoL) is impaired in patients with stable angina but patients often present with other forms of chest pain. The aim of this study was to compare the pre-diagnostic HRQoL in patients with suspected coronary artery disease (CAD) according to angina type, gender, and presence of obstructive CAD. METHODS: From the pilot study for the European DISCHARGE trial, we analysed data from 24 sites including 1263 patients (45.9% women, 61.1 ± 11.3 years) who were clinically referred for invasive coronary angiography (ICA; 617 patients) or coronary computed tomography angiography (CTA; 646 patients). Prior to the procedures, patients completed HRQoL questionnaires: the Short Form (SF)-12v2, the EuroQoL (EQ-5D-3 L) and the Hospital Anxiety and Depression Scale. RESULTS: Fifty-five percent of ICA and 35% of CTA patients had typical angina, 23 and 33% had atypical angina, 18 and 28% had non-anginal chest discomfort and 5 and 5% had other chest discomfort, respectively. Patients with typical angina had the poorest physical functioning compared to the other angina groups (SF-12 physical component score; 41.2 ± 8.8, 43.3 ± 9.1, 46.2 ± 9.0, 46.4 ± 11.4, respectively, all age and gender-adjusted p < 0.01), and highest anxiety levels (8.3 ± 4.1, 7.5 ± 4.1, 6.5 ± 4.0, 4.7 ± 4.5, respectively, all adjusted p < 0.01). On all other measures, patients with typical or atypical angina had lower HRQoL compared to the two other groups (all adjusted p < 0.05). HRQoL did not differ between patients with and without obstructive CAD while women had worse HRQoL compared with men, irrespective of age and angina type. CONCLUSIONS: Prior to a diagnostic procedure for stable chest pain, HRQoL is associated with chest pain characteristics, but not with obstructive CAD, and is significantly lower in women. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02400229.

The role of a commercial radiation dose index monitoring system in establishing local dose reference levels for fluoroscopically guided invasive cardiac procedures.

PURPOSE: The primary goal was to evaluate local dose level for fluoroscopically guided invasive cardiac procedures in a high-volume activity catheterization laboratory, using automatic data registration with minimal impact on operator workload. The secondary goal was to highlight the relationship between dose indices and acquisition parameters, in order to establish an effective strategy for protocols optimization. METHODS: From September 2016 to December 2018, a dosimetric survey was conducted in the 2 rooms of the catheterization laboratory of our institution. Data collection burden was minimized using a commercial Radiation Dose Index Monitoring System (RDIMs) that analyzes dicom files automatically sent by the x-ray equipment. Data were combined with clinical information extracted from the HIS records reported by the interventional cardiologist. Local dose levels were established for different invasive cardiac procedures. RESULTS: A total of 3029 procedures performed for 2615 patients were analyzed. Median KAP were 21 Gycm2 for invasive coronary angiography (ICA) procedures, 61 Gycm2 for percutaneous coronary intervention (PCI) procedures, 59 Gycm2 for combined (ICA+PCI) procedures, 87 Gycm2 for structural heart intervention (TAVI) procedures. A significant dose reduction (51% for ICA procedures and 58% for PCI procedures) was observed when noise reduction acquisition techniques were applied. CONCLUSIONS: RDIMs are effective tools in the establishment of local dose level in interventional cardiology, as they mitigate the burden to collect and register extensive dosimetric data and exposure parameters. Systematic review of data support the multi-disciplinary team in the definition of an effective strategy for protocol management and dose optimization.

Post-Myocardial Infarction Ventricular Septal Defect Closure by a Percutaneous Septal Occluder Device After Unsuccessful Surgical Closure: Never Lose Hope.

Post myocardial infarction ventricular septal defect (VSD) is a life-threatening complication following ST elevation myocardial infarction (STEMI). Current guidelines recommend the urgent VSD closure for its significant mortality. Despite VSD is generally treated by surgical repair, surgeons often refrain from early surgery due to extremely poor results. We report the case of a 76-year-old women admitted to our hospital for a subacute myocardial infarction complicated by acute heart failure with VSD and apical thrombosis. The patient underwent an urgent surgical repair of VSD with a bovine pericardium patch and concomitant double saphenous vein graft for the left anterior descending and the first diagonal branch. After two days an early surgical patch dehiscence was observed and a percutaneous closure was planned. Due to the particular morphology of the unnatural anatomy of the septum generated by the dehiscence, we decided to close the defect using an off-label device for ventricular rupture. A 30/30 mm Amplatzer ASD-MF occluder was successfully implanted. At one-year follow up the patient was alive without significant residual shunt.

Two-year clinical outcomes of the "Italian diffuse/multivessel disease absorb prospective registry" (IT-DISAPPEARS).

BACKGROUND: Large prospective studies on the use of bioresorbable vascular scaffolds (BVS) for diffuse coronary artery disease are lacking. IT DISAPPEARS is a large multicentre prospective registry investigating the short and long-term outcomes of everolimus-eluting BVS in patients with long coronary lesions and/or multivessel coronary artery disease (ClinicalTrials.gov: NCT02004730). We hereby report the 2-year outcomes of the registry. METHODS: We enrolled 1002 patients with complex lesions undergoing implantation of 2040 BVS with a prespecified technique including predilation, correct sizing, and postdilation with non-compliant balloons. The primary endpoint was the rate of device-oriented composite endpoint (DOCE), consisting of cardiac death, target vessel-related myocardial infarction (MI), and ischaemia-driven target lesion revascularization (TLR). Secondary endpoints included: 1) patient-oriented composite endpoint (POCE), consisting of all-cause mortality, all infarctions and all revascularisations; 2) definite/probable scaffold thrombosis. RESULTS: Clinical presentation was an acute coronary syndrome in 59.8% of patients. Total BVS length implanted was 47 ±â€¯22 mm. Postdilation of all scaffolds per patient was performed in 96.8%, while optimal implantation as per study guidelines was applied in 71.4%. Through 2-year follow-up, DOCE occurred in 9.5% of patients (cardiac death 0.6%, target vessel-related MI 5.3%, TLR 6.6%). The rate of POCE was 16.6% and of scaffold thrombosis 1.1%. Female gender, total length of coronary lesions, treatment of bifurcation lesions and use of 2.5 mm scaffolds were independent predictors of DOCE. CONCLUSIONS: The 2-year results of IT-DISAPPEARS show that BVS may yield acceptable clinical outcomes in patients with complex coronary lesions when the implantation technique is appropriate.

Metabolomic fingerprint of coronary blood in STEMI patients depends on the ischemic time and inflammatory state.

In this study we investigated whether the metabolomic analysis could identify a specific fingerprint of coronary blood collected during primary PCI in STEMI patients. Fifteen samples was subjected to metabolomic analysis. Subsequently, the study population was divided into two groups according to the peripheral blood neutrophil-to-lymphocyte ratio (NLR), a marker of the systemic inflammatory response. Regression analysis was then applied separately to the two NLR groups. A partial least square (PLS) regression identified the most significant involved metabolites and the PLS-class analysis revealed a significant correlation between the metabolic profile and the total ischemic time only in patients with an NLR > 5.77.

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.

Acute myocardial infarction secondary to blunt chest trauma in motorcycle accident: A rare combination where percutaneous coronary intervention and intravascular imaging optimization are needed.

Blunt chest trauma is a common occurrence in vehicle accident. Cardiac injuries following nonpenetrating thoracic trauma have been reported. ST-elevation myocardial infarction (STEMI) due to coronary artery involvement is a rare but extremely serious condition for the high risk of undetected diagnosis. Blunt thoracic trauma may obscure typical chest pain associated with cardiac ischemia especially in patients with high tolerance of pain or secondary administration of analgesic drugs. We report two consecutive cases of young adults admitted to our emergency department after motorcycle accident and concomitant anterior STEMI due to occlusion of left anterior descending artery. In both cases primary percutaneous coronary intervention with a second generation drug eluting stent implantation was successfully performed. Imaging with intravascular ultrasound and optical coherence tomography showed the mechanisms of coronary occlusion, allowing an optimal stent implantation and avoiding procedural complications in this complex setting.

Exclusion of a giant saphenous vein graft pseudo-aneurysm with a "double-layer bridging" technique.

We report the case of a 72-year-old man admitted to our hospital for chest pain. He had undergone coronary artery bypass graft surgery 23 years before. Contrast-enhanced computer tomography revealed a severe double-lobed dilatation of the saphenous vein graft for the obtuse marginal branch. Coronary angiography did not opacify completely the saphenous vein graft for the huge turbulence in the dilatation. Severe saphenous vein graft dilatation have a significant mortality and it has been generally treated by surgical repair, such as resection with or without bypass of the affected territory. We described an interventional technique, named "double-layer bridging" that combines metallic DES and covered stent used in a double layer. This percutaneous technique, relatively simple and virtually usable for any type of severe dilatation independently of length, can be a reasonable and safe option to exclude giant aneurysm and maintaining distal flow.

"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.

A Survey on Coronary Atherosclerotic Plaque Tissue Characterization in Intravascular Optical Coherence Tomography.

PURPOSE OF REVIEW: Atherosclerotic plaque deposition within the coronary vessel wall leads to arterial stenosis and severe catastrophic events over time. Identification of these atherosclerotic plaque components is essential to pre-estimate the risk of cardiovascular disease (CVD) and stratify them as a high or low risk. The characterization and quantification of coronary plaque components are not only vital but also a challenging task which can be possible using high-resolution imaging techniques. RECENT FINDING: Atherosclerotic plaque components such as thin cap fibroatheroma (TCFA), fibrous cap, macrophage infiltration, large necrotic core, and thrombus are the microstructural plaque components that can be detected with only high-resolution imaging modalities such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT). Light-based OCT provides better visualization of plaque tissue layers of coronary vessel walls as compared to IVUS. Three dominant paradigms have been identified to characterize atherosclerotic plaque components based on optical attenuation coefficients, machine learning algorithms, and deep learning techniques. This review (condensation of 126 papers after downloading 150 articles) presents a detailed comparison among various methodologies utilized for plaque tissue characterization, classification, and arterial measurements in OCT. Furthermore, this review presents the different ways to predict and stratify the risk associated with the CVD based on plaque characterization and measurements in OCT. Moreover, this review discovers three different paradigms for plaque characterization and their pros and cons. Among all of the techniques, a combination of machine learning and deep learning techniques is a best possible solution that provides improved OCT-based risk stratification.

Absorb bioresorbable vascular scaffold vs. everolimus-eluting metallic stent in small vessel disease: A propensity matched analysis of COMPARE II, RAI, and MAASSTAD-ABSORB studies.

BACKGROUND: Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern. OBJECTIVE: We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies. METHODS: Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific. RESULTS: Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04). CONCLUSION: In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group.

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.