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Optimal treatment of renal artery "in-stent restenosis" (ISR) is still debated; drug eluting stents (DES), drug coated balloons (DCB) and scoring balloons have all been used, with mixed long term results. The shockwave lithotripsy for the treatment of heavily calcified atherosclerotic plaques has proven to be an effective tool and preliminary data support its use in case of underexpanded stents. Here we present the case of a 60 year old male with a known significant atherosclerotic renal artery stenosis and refractory hypertension who already underwent bilateral renal angioplasty with bare metal stents (BMS) in 2011 and angioplasty with DCB in 2012 for right renal artery ISR. In May 2020 he presented with worsening hypertension and CT scan showed total occlusion of the right with critical ISR of the left renal artery. Because of the high calcium burden he underwent balloon lithotripsy for plaque modification and subsequent renal angioplasty with sirolimus and paclitaxel DCB, with a good angiographic result. This is the first case of recurrent renal ISR successfully treated with Shockwave IVL and double-drug DCB therapy.

Background Postoperative pericardial effusion (pPE) still remains a frequent complication after congenital heart surgery and it usually leads to an increased morbidity and re-hospitalization rate. There are only few published papers about pPE clinical course or large randomized studies that analyze its prevalence or preoperative risk factors. In this regard, we report a single-center 10-years retrospective analysis of prevalence, outcomes and risk factors of postoperative pericardial effusion after congenital heart surgery. Methods A retrospective analysis was carried out on 624 patients who underwent congenital heart surgery from January 2010 to December 2019. Study population was divided in two groups basing of the presence of pPE during the first 30 days after the surgery and their perioperative data were compared. Univariate and multivariate analysis were used to find possible risk factors for pPE developing. Results Ninety-four patients were enrolled in pPE group and 530 in ¬ pPE group. Pericardial effusion was assessed as “mild” in 57 patients (60,6%), as “moderate” in 25 (26,6%), and as “severe” in 12 patients (12,8%). Total correction of Tetralogy of Fallot/Pulmonary atresia seems to be associated with a higher prevalence of pPE in the “Infant” subgroup, while atrial septal defect showed to be a risk factor among “Toddler”. In addition, pPE was proved to be much more frequent in Fontan patients in all studied subgroups. Univariate and multivariate analysis revealed that total drain amount, Fontan procedure, postoperative Warfarin therapy, Redo-operations and surgical correction of Tetralogy of Fallot/Pulmonary atresia seem to be risk factors for pPE. Postoperative pericardial effusion was diagnosed between the 4th and the 28th postoperative day but in 88,3% of the cases (83/94) it occurred before the 14th day after the operation. In 58 patients, pPE was clinically silent. Conclusions Postoperative pericardial effusion was detected in 88.3% of cases within the first 14 days after the operation. About 69% of these patients were asymptomatic therefore it suggests that routinely echocardiogram after intensive care unit discharge could be a useful tool to screen clinically silent pPE at an early stage, especially in high-risk or unstable patients.

Objectives This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular...

Aims The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up. Methods EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months. Results Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008). Conclusion The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.

Stent underexpansion increases the risk of cardiac adverse events. At present, there are limited options to treat refractory stent underexpansion. In this context, the intravascular lithotripsy (IVL) system might be a safe and effective strategy.We aimed to evaluate the safety and efficacy of IVL in addressing resistant stent underexpansion due to heavy underlying calcification.This was an international multicentre registry including patients receiving IVL therapy to treat stent underexpansion from December 2017 to August 2020. Angiographic and intracoronary imaging data were collected. The efficacy endpoint was device success (technical success with a final percentage diameter stenosis50%). The safety endpoint was in-hospital major adverse cardiac events (MACE).Seventy patients were included, the mean age was 73±9.2 years and 76% were male. The median time from stent implantation to IVL therapy was 49 days (0-2,537). Adjuvant treatment with non-compliant balloon dilatations pre- and post-IVL was performed in 72.3% and 76.8% of patients, respectively, and additional stenting was performed in 22.4%. Device success was 92.3%. Minimum lumen diameter increased from 1.49±0.73 mm to 2.41±0.67 mm (p0.001) and stent expansion increased by 124.93±138.19% (p=0.016). No IVL-related procedural complications or MACE were observed. The use of bailout IVL therapy directly after stenting and the presence of ostial underexpanded lesions negatively predicted lumen diameter gain.Coronary lithotripsy is safe and effective in increasing lumen and stent dimensions in underexpanded stents secondary to heavily calcified lesions.

Carotid artery stenting (CAS) is a valid and effective alternative to endoatherectomy when performed by experienced operators. The conventional approach used is the transfemoral one, but in the last 10 years a transradial (TR) approach, the standard access for cardiac catheterization, became widely adopted for peripheral vascular interventions, included the extracranial carotids. Preliminary experiences suggest this approach as safe and effective, especially in specific anatomical and clinical settings that have been shown to be associated with high risk of complications from the femoral route. Lacking international guidelines, this document, promoted by the Italian Society of Interventional Cardiology - Gruppo Italiano Studi Emodinamici (SICI-GISE), was drawn-up by a panel of interventional cardiologists with a documented experience on the subject, focusing on the indications, techniques and materials that should be used for this type of intervention and the most recent literature on the subject.

Objective Our study sought to compare the 12-month clinical outcome of patients treated with paclitaxel-coated balloons (PCB) vs. sirolimus-coated balloons (SCB) during coronary angioplasty . Background Drug-coated balloons represent an established therapeutic tool for percutaneous coronary interventions (PCI). A comparison between PCB and SCB is still lacking. Methods We performed an indirect comparison between two cohorts of patients previously included into two investigator-driven registries with clinical primary endpoints, 494 treated with the Elutax SV PCB (AR Baltic, Lithuania) from the DCB RISE registry, and 596 treated with the Magic Touch SCB (Concept Medical, India) from the EASTBOURNE registry. The primary endpoint was the rate of major adverse cardiovascular events (MACE) at 12-month clinical follow-up. Results After propensity score matching , a total of 580 patients were well matched for baseline clinical and procedural characteristics and were analyzed. At 12 months there was no significant difference between the matched DCB RISE and EASTBOURNE cohorts in terms of the primary endpoint MACE (10.3% DCB RISE vs. 10.7% EASTBOURNE, p = 0.892). No significant difference was observed also regarding the rate of TLR (7.9% DCB RISE vs. 8.3% EASTBOURNE; p = 0.879, respectively). By multivariate analysis , insulin-dependent diabetes was the only predictor of MACE. Conclusions In the SIRPAC study, the first indirect comparison between paclitaxel-coated and sirolimus coated balloons, no significant difference in clinical endpoints were found at 12-month follow-up. Randomized studies are necessary to confirm these findings.

This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions.Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes.The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months.Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm.In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).

Background In this study, we compared our experience about early and midterm follow-up outcomes for right anterolateral minithoracotomy (RAMT) vs full sternotomy (FS) in surgical aortic valve replacement (AVR) among adolescents with bicuspid aortic valve (BAV). Methods Patients were retrospectively enrolled from January 2008 to December 2017. Inclusion criteria were patients with BAV who had to undergo to AVR. They were divided in two groups: RAMT and FS. The choice of RAMT was based on individual surgeon's preferences or when expressly requested by patient that was informed of nonconventional approach. Results We enrolled 61 patients, 23 in RAMT group and 38 in FS group. The mean age was 15.6 ± 1.7 years for RAMT group and 16.1 ± 1.5 years for FS group (P = .23). The RAMT group had a higher prevalence of female gender (P = .04). The patients in the RAMT group had longer cardiopulmonary bypass (115.2 ± 18.5 vs 102.2 ± 16.5 min; P = .006) and cross-clamp time (78.6 ± 18.1 vs 74.3 ± 15.2 min; P = .01). No patients required intraoperative conversion to FS. No differences were found in ventilation times, postoperative intensive care unit (ICU), and hospital length of stay for both groups. Follow-up echocardiograms were available for all patients at median of 5.2 years (range 0.5-9.6 years, median 5.4 years for RAMT and 5.1 for FS) and no patient required reoperation for aortic prosthesis malfunction. Conclusions Our study shows that RAMT is safe and effective as FS. Although the RAMT operation takes slightly more operation time, it is not associated with major adverse effects.

Percutaneous treatment of the unprotected left main trunk (ULM), defined as a vessel without patent bypass graft either to the left circumflex (LCX) or left anterior descending (LAD) artery, has gained a precise role thanks to recent scientific evidence. Although new generation drug-eluting stents have already proven to be safer, there is still a consistent risk of restenosis and late adverse events. The optimal management of a ULM restenosis is still debated. Here we aim at presenting a review of the available data in literature and show our choice for treating it.

Aims Drug-coated balloons (DCBs) are a recognized alternative to stents for the treatment of in-stent restenosis (ISR), and there is some initial clinical evidence about their efficacy for the treatment of small coronary vessels. Newer-generation DCBs were developed to overcome the reduced deliverability of the previous generation, also warranting a more effective drug delivery to vessel wall. However, the vast majority of new-generation DCBs still lack of reliability due to paucity of clinical data. Methods Between 2012 and 2015, all patients treated with Elutax SV DCB (Aachen Resonance, Germany) at nine Italian centers were enrolled in this retrospective registry. Primary outcome was the occurrence of target-lesion revascularization (TLR) at the longest available follow-up. Secondary endpoints were procedural success and occurrence of device-oriented adverse cardiovascular events including cardiac death, target-vessel myocardial infarction, stroke, and TLR. A minimum 6-month clinical follow-up was required. Results We enrolled 544 consecutive patients treated at 583 sites. Fifty-three per cent of the patients had ISR, and the rest native vessel coronary artery disease. Procedural success occurred in 97.5%. At the longest available clinical follow-up (average 13.3 ± 7.4 months), 5.9% of the patients suffered a TLR and 7.1% a device-oriented adverse cardiovascular event. We did not register cases of target-vessel abrupt occlusion. At multivariate analysis, severe calcification at the lesion site was the first determinant for the occurrence of TLR. Conclusion This registry on the performance of a new-generation DCB shows an adequate profile of safety and efficacy at mid-term clinical follow-up.

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.

Cardioplegic arrest represented one of the most important (probably the greatest) achievement of cardiac surgery in the last 40 years because it allowed, on one hand, the feasibility of treating all heart pathologies with a stopped and bloodless heart and then to ensure, at the same time, myocardial protection during the ischemic period.

Background and purposes Drug-coated balloons (DCB) currently represent an alternative to drug-eluting stents (DES) for the treatment of in-stent restenosis and they are also variably used for small coronary vessel and bifurcation lesion management. All DCB variably elute paclitaxel as an anti-proliferative drug. The first sirolimus coated balloon (SCB) received the CE mark in 2016, but its clinical performance has not been shown yet. Methods and results FASICO in an all-comer registry of the first consecutive patients with at least one lesion treated with SCB between March and July 2016 at the first European centre that used this device. All patients were prospectively enrolled in a dedicated database. Primary endpoint was procedural success; co-primary endpoint was the rate of major adverse cardiac events at short-term follow-up. The 32 patients (34 lesions) enrolled had at least 6-month clinical follow up available. Forty-five percent had diabetes and indication to PCI was ISR in 47% of the cases. Lesions were always pre-dilated and device deployment was successful in all the cases. Procedural success was achieved in 100% of patients. We observed 3 cases of TLR at follow-up. Conclusions SCB shows high immediate technical performance and adequate short-term efficacy and safety. The ongoing EASTBOURNE registry will shed light on mid-and long-term performance of this device in an adequately powered population.

Background This study aimed to explore systematically procedural results, clinical benefits with echocardiographic and chest-MRI assessment of pulmonary sequestration percutaneous treatment. Methods 13 consecutive infants and children with diagnosis of isolated pulmonary sequestration (PS) had percutaneous closure of the aberrant artery supplying pulmonary sequestration between 2010 and 2015. By protocol, echocardiographic and chest-MRI assessment was performed before and respectively at 6–12months and 1year with the aim to study the effects of embolization on heart volume overload and regression of pulmonary sequestration. Results Median age at diagnosis was 1year (95%CI 0–2.6); median age at treatment was 1.3years (95%CI1.01–2.85). In all pts the PS was confirmed by chest-MRI. Procedural success was 100%. After treatment, pts experiencing previously respiratory symptoms/infections remained asymptomatic at 2.9year follow-up. In pts with significant shunt due to PS, treatment resulted in amelioration in left or right cardiac chamber enlargement at 6 and 12month follow-up. At distance from PS closure (median 14months), chest-MRI confirmed the closure of the aberrant artery and PS regression in 12 patients. In one case, despite the acute procedural success and the supplying artery remained closed, MRI detected residual PS revascularization. Conclusions Percutaneous PS closure in infants and children is safe and provide regression in respiratory symptoms and heart chamber dilatation if significant shunt is present. MRI is able to define aberrant artery course and PS parenchima, and might represent a valid instrument to study residual PS parenchima during growth.

Objectives to understand the role of a transradial (TR) secondary approach during complex percutaneous interventions. Background The value of the TR route for ancillary vascular approach has not been adequately validated in this setting, and there is scant data on its role in reducing bleeding complications. Methods In the present study we retrospectively included patients undergoing the following interventions requiring two vascular approaches at nine high-volume centers in Italy: structural cardiac interventions, complex PCI, endovascular aortic repair (EVAR) and complex lower limb angioplasty. We compared procedural outcomes according to the type of ancillary vascular approach selected, namely TR or transfemoral/transbrachial (TF/TB). Primary endpoints of the study were procedural success and in-hospital BARC grade 3–5 bleedings. Results We included 906 patients, 433 receiving TR and 473 TF/TB ancillary approaches. Baseline characteristics did not differ significantly. Patients underwent the following types of intervention: structural 50%, complex coronary PCI 37%, EVAR 11%, peripheral angioplasty 2%. Procedural success was similar (90% in TR and 92% TF/TB, P = NS). In-hospital BARC 3/5 bleedings were more common in TF/TB group as compared to TR group (19.7% vs. 6.7%,P

Objectives To test the long-term efficacy of a sirolimus-coated balloon (SCB). Background Nanolute was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data. Methods All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI). Results A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%). Conclusion The Nanolute prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.

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.

Aims To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting. Background Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available. Methods 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones. Results After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71). Conclusion Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

Purpose: Redo operations and preoperative antiplatelet/anticoagulant therapy can significantly increase surgical risk in congenital heart surgery. This is a retrospective study on the impact of preoperative aspirin therapy on the outcome of Tetralogy of Redo Fallot patients undergoing right ventricle outflow tract (RVOT) conduit implantation. Methods: Ten-years retrospective analysis of medical records was carried out. A total of 72 patients were divided into two groups: &ldquo, Daily-on-ASA&rdquo, group on daily therapy with aspirin (ASA) until 5 days from surgery and &ldquo, No-Home-ASA&rdquo, without it. Propensity match analysis was done in order to standardize the populations. Intraoperative and postoperative lengths were compared as well as the need for inotropic support. In addition, differences in blood transfusions and need for Fresh frozen plasma (FFP)/platelets (PLT) were analysed. Findings: Intraoperative lengths were similar between the groups. Not statistically significative differences about postoperative time to extubation (p = 0.34), ICU Stay (p = 0.31) or in-hospital stay (p = 0.36) were found. Drain loss was higher in the &ldquo, group (407.9 &plusmn, 96.7 mL vs. 349.5 &plusmn, 84.3 mL, p = 0.03) as well as blood transfusions (372.7 &plusmn, 255.1 mL vs. 220.1 &plusmn, 130.3 mL, p = 0.02) and PLT/FFP need (217.7 &plusmn, 132.1 mL vs. 118.7 &plusmn, 147.1 mL, p = 0.01). No differences were found in postoperative complications or re-explorations for bleeding. Implications: We found no advantages in surgical times and hospital stay comparing redo patients who stopped aspirin versus those that didn&rsquo, t take it in the last 6 months. However, our results suggest that redo patients undergoing RVOT conduit implantation who take daily aspirin are at higher risk of bleeding even if it is stopped 5 days before surgery.

Drug-coated balloons (DCB) are being used for in-stent restenosis treatment and there is some preliminary experience in other coronary settings, including small vessels and side branches. Scoring balloons (SB) are a useful tool for the preparation of fibro-calcific lesions. Because of the controlled micro-dissections that SB induce, it has been hypothesized that they may have a role in helping paclitaxel deliverability inside the vessel wall. The AngioSculpt®X (Spectranetics) is a novel paclitaxel-coated SB with encouraging preliminary data for the treatment of in-stent restenosis. We here describe our first experience treating two de novo coronary lesions with angiographic follow up.

The nucleolus is a distinct sub-cellular compartment structure in the nucleus. First observed more than 200 years ago, the nucleolus is detectable by microscopy in eukaryotic cells and visible during the interphase as a sub-nuclear structure immersed in the nucleoplasm, from which it is not separated from any membrane. A huge number of studies, spanning over a century, have identified ribosome biogenesis as the main function of the nucleolus. Recently, novel functions, independent from ribosome biogenesis, have been proposed by several proteomic, genomic, and functional studies. Several works have confirmed the non-canonical role for nucleoli in regulating important cellular processes including genome stability, cell-cycle control, the cellular senescence, stress responses, and biogenesis of ribonucleoprotein particles (RNPs). Many authors have shown that both canonical and non-canonical functions of the nucleolus are associated with several cancer-related processes. The association between the nucleolus and cancer, first proposed by cytological and histopathological studies showing that the number and shape of nucleoli are commonly altered in almost any type of cancer, has been confirmed at the molecular level by several authors who demonstrated that numerous mechanisms occurring in the nucleolus are altered in tumors. Recently, therapeutic approaches targeting the nucleolus in cancer have started to be considered as an emerging “hallmark” of cancer and several therapeutic interventions have been developed. This review proposes an up-to-date overview of available strategies targeting the nucleolus, focusing on novel targeted therapeutic approaches. Finally, a target-based classification of currently available treatment will be proposed.

Background Radial artery approach is currently the most common access site for coronary angiography and percutaneous coronary intervention. It rarely results in complications, improves patient comfort, and reduces the duration of hospitalization. Case presentation A 91-year-old woman presented to our institution with ST-segment elevation myocardial infarction (STEMI). The right radial access was chosen for the performance of percutaneous coronary intervention. After the introduction of 6 F sheath, there was difficulty in the advancement of 0.035 J wire that was exchanged with a Terumo hydrophilic wire. After the procedure and before sheath removal, radial arteriography was done and revealed perforation. Protamine sulfate was administered and prolonged balloon inflation was attempted but failed to seal the perforation, so a 7-F-long vascular sheath was inserted to internally tamponade the vessel, and the patient was sent to the coronary care unit for monitoring. Over the next 3 days, serial radial angiographies were done revealing the persistence of the perforation, and on the fourth day, angiography revealed multiple thrombi. Thrombus aspiration was done using Pronto V4 extraction catheter (Vascular Solutions, USA) and was followed by the deployment of a covered stent. The stent was dislodged and successfully snared. Finally, the perforation was sealed spontaneously and there were no signs of intra-arterial thrombi. Conclusion Despite the very low complication rate of radial approach, the interventional cardiologist should be aware of any possible complication, and how to avoid or, eventually, manage it.

Coronary Sinus Reducer (Neovasc, Inc., Richmond B.C., Canada) has shown to be an effective and safe treatment option for the treatment of refractory angina. Until now, a few number of complications related to its implantation have been reported. Coronary sinus perforation is a rare complication, more often related to cardiac surgery procedures. We report the first case of coronary sinus perforation after a sinus Reducer implantation.

In the “pre-stent era,” the immediate and midterm outcome of percutaneous transluminal coronary angioplasty (PTCA) was severely affected by restenosis, abrupt vessel closure, and coronary dissection. Regardless of the angiographic and morphological classification {Waller:1992tr}, the incidence of coronary dissection after PTCA has been reported ranging from 4% to 45% {Dorros:1983wf}{GuiterasVal:1987wy}, while autoptic studies showed the presence of coronary dissections in up to 80% of the cases, independently from the cause of death {Baughman:1981gb}, of patients treated with balloon angioplasty.

The economic impact of drug-coated balloons (DCB) has been a matter of great debate in the latest years in many nations worldwide. Angioplasty with DCBs proved to be an effective and safe strategy both in coronary and peripheral interventions, mainly for the treatment of in-stent restenosis (ISR), native coronary vessel disease, and femoropopliteal disease. However, the immediate costs related to an endovascular procedure using DCBs are significantly higher than those related to a plain old balloon angioplasty (POBA), bare-metal stents (BMS), or drug-eluting stents (DES). Thus, their cost-effectiveness in the long term needed to be assessed, to test whether the reduction in target lesion revascularization (TLR) or major adverse events provided by this new class of devices may have a positive impact on national health systems. Given the existing differences between different health systems (e.g., costs, reimbursements, etc.), it is difficult to draw conclusions that could be generally accepted worldwide [1]. Nevertheless, in recent years some studies have addressed this topic, both in the field of coronary and peripheral interventions.

Nowadays, limus-eluting stents dominate the world of drug-eluting stents (DES) and proved to be superior to paclitaxel-eluting stents in terms of efficacy and safety [1].

Coronary lesions at bifurcation sites are frequent and still remain a challenging subset for the interventional cardiologist. Although in the last years the provisional stenting technique has shown more consistent results, coronary bifurcation interventions still share a worse procedural success rate and increased rates of mid- and long-term cardiac events. Most of the dedicated devices proposed in the last few years have failed to show improved results when compared with standard devices. The broader use of imaging techniques, such as intravascular ultrasound and optical coherence tomography, lead to a better understanding of the real anatomy of bifurcations and has shown to be a great tool for percutaneous coronary intervention optimization. Preliminary results come from drug-coated balloons and bioresorbable vascular scaffolds, especially for the ‘leave nothing behind’ concept, particularly interesting in this setting of lesions.

Background The aim of the Nanolute registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions. Methods All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction. Results A total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (average ± SD) were 21.83 ± 6.70 mm and 2.69 ± 0.45 mm respectively. All patients with 1 year follow-up were included. Overall DOCE rate was 4.2% (n = 14) which included death 0.3% (n = 1), TLR 3.6% (n = 12) and myocardial infarction 0.3% (n = 1). Conclusion The Nanolute prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions.

Background The transatrial repair of the ventricular septal defect (VSD) requires an adequate exposure of its rim. We retrospectively evaluated the effect of using the tricuspid valve incision (TVI) technique, with detachment or radial incision, on the postoperative outcome of children undergoing surgical VSD repair. Methods From January 2008 to September 2017, we retrospectively enrolled 141 patients, divided into two groups: 97 patients (68.8%) underwent TVI and 44 patients (31.2%) did not undergo TVI. All patients received an echocardiogram upon discharge from the hospital and after 1 month, 3 months, 6 months, and 1 year from the treatment. Results No perioperative or late deaths occurred. TVI was associated with a slightly longer cardiopulmonary bypass and cross-clamp time, but there were no differences in the surgical outcome between the two groups. Moreover, no differences occurred concerning residual VSD, atrioventricular block, or tricuspid regurgitation at discharge. Echocardiograms at follow-up were available for 134 patients (95%) with a median of 5.3 years (range, 0.5 to 9.3 years), and the degree of tricuspid regurgitation did not differ between groups. No patient required reoperation for tricuspid regurgitation or residual interventricular shunt. Finally, no difference was found when the two TVI subgroups were compared. Conclusions TVI should be used whenever intraoperative exposure of VSD is compromised to avoid a residual shunt and atrioventricular block. Here we show that this procedure does not significantly compromise tricuspid function, although a large, multicenter, randomized controlled trial is advised to validate this hypothesis.

Background In the recent years percutaneous treatment of the left main stem (LM) has gained a precise role as a result of consistent scientific evidence vs. coronary artery bypass. A self-apposing stent offers an improved adaptation to the vessel wall, especially in case of tapered vessels; aim of this study was to investigate the role of a novel self-apposing, sirolimus-eluting stent (Stentys, France) for the treatment of LM coronary artery disease. Methods and results MATISSE is a retrospective, multicenter registry, which enrolled 151 patients treated with the device at 17 international centers. Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE), a composite endpoint of cardiac death, target lesion revascularization (TLR) and target-vessel myocardial infarction, at 9 months clinical follow-up. Secondary endpoints included procedural success, the single determinants of MACE and stent thrombosis. Lesions were located in distal LM bifurcation in 84% of the patients. Procedural success was achieved in 150 patients. The average follow-up length was 348 ± 52 days. MACE occurred in 14 (9.3%) patients with 2 (1.3%) cardiac deaths. TLR occurred in 8 patients (5.3%). There were 2 cases of definite stent thrombosis, 1 acute and 1 very late. Conclusions A self-apposing stent, when used for LM PCI in a real world, high risk population, showed good immediate procedural results with low rates of adverse events at mid-term follow-up.

Background: Congenital heart disease is a common birth defect rather than a paediatric disease. Parents often discover this disease after their children's birth and then often learn that cardiac surgery is the only solution. A child's admission to a paediatric cardiac intensive care unit (PCICU) may lead to high levels of stress, anxiety and depression in parents. Objectives: To describe the lived experiences of mothers and fathers during their children's confinement in a PCICU. Methods: A phenomenological study was conducted. This method combines descriptive features (Husserlian) and interpretive phenomenology (Gadamerian). The subjects were interviewed with open questions to allow them full freedom of expression and were asked to describe their experiences when their children were admitted to the PCICU. Each interview was audio-recorded and lasted between 20 and 60 minutes. The researchers involved in the analysis each independently immersed themselves in the data by reading and re-reading the transcripts in order to gain a sense of the whole dataset. The extrapolation of the themes followed. The individual researchers compared the various extrapolated themes. Results: We enrolled 16 participants. Three main themes emerged: 1) the fear of the potential loss of their children, (2) the feeling of having lost their roles as parents and (3) the desire to receive more information and be an active part of the treatment process. Conclusion: A child's admission to a PCICU requires healthcare staff to take care of the child's family members as well. Knowing about mothers’ and fathers’ experiences is crucial in implementing a holistic and multidisciplinary process of care.

Coronary artery anomalies (CAA) are common in many congenital heart disease (1,2) and to know the origin and the course of coronary artery is essential for patients when underwent cardiac catheterization or surgery.

Introduzione: I difetti cardiaci sono molto comuni nell’età pediatrica; spesso i genitori scoprono, dopo la nascita, queste patologie ed apprendono che l’intervento di cardiochirurgia è l’unica soluzione. Il ricovero del proprio bambino in una Terapia Intensiva comporta elevati livelli di stress, ansia, depressione. Gli infermieri assumono un ruolo attivo nell’assistenza del piccolo degente ma anche nella presa in carico dell’intero nucleo familiare. Obiettivo: scopo dello studio è stato descrivere l’esperienza dei genitori dei bambini ricoverati in una unità di Terapia Intensiva cardiochirurgica. Metodo: disegno ermeneutico fenomenologico secondo Cohen. Risultati: dall’analisi di 16 interviste sono emersi 3 temi principali: la paura per la possibile perdita del proprio bambino; la sensazione di aver perso il ruolo di genitore e la bisogno di ricevere maggiori informazioni per poter essere parte attiva nel processo di cure. Conclusioni: Il ricovero di un bambino in una Terapia Intensiva e, nello specifico, di cardiochirurgia, impone al personale assistenziale la presa in carico dell’intero nucleo familiare. Gli Infermieri sono i primi professionisti dai quali i genitori si attendono tale coinvolgimento. Questo studio offre uno sguardo sull’esperienza vissuta dai genitori che hanno il proprio figlio ricoverato in una Terapia Intensiva di cardiochirurgia; inoltre può rappresentare lo spunto per ulteriori ricerche finalizzate alla olistica armonizzazione tra la diade (famiglia e bambino) spesso ingiustamente scisse durante il ricovero in Terapia Intensiva.

Objectives With this prospective study we aim at investigating the long-term outcome of a consecutive cohort of patients successfully treated with bioresorbable scaffold (BVS) implantation. Background It is not clearly understood if there is a relation between the technique of BVS implantation and the outcome. Methods Between December 2012 and December 2014, all consecutive patients treated with BVS were included in this registry and received an angiographic follow-up. After a run-in phase, all BVS were implanted using a specific technique consisting of aggressive predilation, correct scaffold sizing, visually determined, and high-pressure post-dilation with a noncompliance balloon. Primary endpoint was late lumen loss (LLL) at 1-year angiographic follow-up and ischemia-driven target-lesion revascularization (ID-TLR) at 2-year clinical follow-up. Secondary endpoints were the occurrence of binary restenosis, major adverse cardiac events (MACE), and every single component of MACE (cardiac death, myocardial infarction, TLR) at 2 years. Results A total of 144 lesions in 122 patients treated consecutively with BVS, were enrolled. Diabetics were 29.5% and acute coronary syndrome at presentation occurred in 29.5% of patients. At the angiographic follow-up LLL was 0.38 ± 0.9. At 2-year clinical follow-up, ID-TLR occurred in eight patients (5.6%). We observed two cases of scaffold thrombosis (1.38%, one early and one very late). At multivariate statistical analysis, STEMI presentation remained a significant predictor for TLR. Conclusions In a complex, all-comers real world population, BVS implantation with a specific, and standardized technique showed to be feasible, with acceptable mid-term angiographic and long-term clinical outcome.

Objectives The aim of this study is to evaluate the role of drug-coated balloons (DCB) for the management of bioresorbable vascular scaffold (BVS) restenosis. Methods and results In a series of 25 BVS restenosis discovered during systematic angiographic follow up of 246 consecutive BVS implantations at our institution, DCB was used as a primary therapeutic tool in 9 patients and 3 different types of DCB were used. Follow-up coronary angiography at 12 months after DCB treatment was performed to all the patients. Among the 9 patients treated with DCB, angiographic follow up revealed failure in two patients that experienced type III restenosis (both of them treated with the same type of DCB). Both patients were treated with drug eluting stent implantation. Conclusions In this case series of consecutive patients with BVS restenosis, the use of certain types of DCB is safe and effective in order to maintain vessel patency at mid-term follow up. Despite the small sample size and the study limitations, DCB can provide therefore an alternative treatment option in this setting, avoiding the implantation of further metallic stents in a patient where a different strategy was initially planned.

Background Due to the inherent limitations of current generation BVSs, complex coronary artery disease often contains BVS unsuitable segments. Our aim was to assess the feasibility of a hybrid approach using bioresorbable vascular scaffolds (BVSs) and drug-eluting stents (DESs) for the treatment of complex coronary artery lesions not suitable for a scaffolding only approach. Methods A retrospective multicenter cohort analysis was performed on patients with complex de novo or in-stent restenosis lesions treated with a hybrid BVS (Absorb BVS, Abbott Vascular, Santa Clara, CA) and DES strategy. The primary endpoint was target lesion failure (TLF) defined as a composite of cardiac death, target-vessel myocardial infarction (MI) and target lesion revascularization (TLR). Results A total of 98 patients (105 lesions) were treated with the hybrid strategy. Isolated long lesions in which either proximal or distal reference vessel diameters were not suitable for BVS were an indication in 36.2% (n = 38) of cases. In contrast, 28% (n = 29) of lesions treated with the hybrid strategy were bifurcations in which the side branch was predominantly treated with DES (n = 28). DES bailout after BVS implantation was an indication in 21.9% (n = 23 lesions). The rates of type B2/C and long lesions (>28 mm) were 95.2% and 74.3% respectively. The mean total BVS and DES lengths implanted were 37.5 ± 24.1 mm and 25.0 ± 14.7 mm respectively. The rate of TLF in the overall cohort of patients (median follow-up 405 days [interquartile range 189–658]) was 11.4% at 1-year. This was primarily driven by TLR (9.5%), with rates of cardiac death and target vessel MI of 2.1% and 1.4% respectively. No cases of definite or probable BVS/DES thrombosis occurred. Conclusion In conclusion, the use of a hybrid BVS/DES strategy was feasible and associated with acceptable outcomes at 1-year, considering the length and complexity of lesions treated. Further, larger studies with longer follow-up are needed to confirm our findings.

BACKGROUND AND PURPOSE: The pulvinar sign refers to exclusive T1WI hyperintensity of the lateral pulvinar. Long considered a common sign of Fabry disease, the pulvinar sign has been reported in many pathologic conditions. The exact incidence of the pulvinar sign has never been tested in representative cohorts of patients with Fabry disease. The aim of this study was to assess the prevalence of the pulvinar sign in Fabry disease by analyzing T1WI in a large Fabry disease cohort, determining whether relaxometry changes could be detected in this region independent of the pulvinar sign positivity. MATERIALS AND METHODS: We retrospectively analyzed brain MR imaging of 133 patients with Fabry disease recruited through specialized care clinics. A subgroup of 26 patients underwent a scan including 2 FLASH sequences for relaxometry that were compared with MRI scans of 34 healthy controls. RESULTS: The pulvinar sign was detected in 4 of 133 patients with Fabry disease (3.0%). These 4 subjects were all adult men (4 of 53, 7.5% of the entire male population) with renal failure and under enzyme replacement therapy. When we tested for discrepancies between Fabry disease and healthy controls in quantitative susceptibility mapping and relaxometry maps, no significant difference emerged for any of the tested variables. CONCLUSIONS: The pulvinar sign has a significantly lower incidence in Fabry disease than previously described. This finding, coupled with a lack of significant differences in quantitative MR imaging, allows hypothesizing that selective involvement of the pulvinar is a rare neuroradiologic sign of Fabry disease.