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Background: The aim of this research is to describe the performance over time of transcatheter aortic valve implantations (TAVIs) in a high-volume center with a contemporary, real-world population., Methods: Patients referred for TAVIs at the University Hospital of Verona were prospectively enrolled. By cumulative sum failures analysis (CUSUM), procedural-control curves for standardized combined endpoints-as defined by the Valve Academic Research Consortium-2 (VARC-2)-were calculated and analyzed over time. Acceptable and unacceptable limits were derived from recent studies on TAVI in intermediate and low-risk patients to fit the higher required standards for current indications., Results: A total of 910 patients were included. Baseline risk scores significantly reduced over time. Complete procedural control was obtained after approximately 125 and 190 cases for device success and early safety standardized combined endpoints, respectively. High risk patients (STS ≥ 8) had poorer outcomes, especially in terms of VARC-2 clinical efficacy, and required a higher case load to maintain in-control and proficient procedures. Clinically relevant single endpoints were all influenced by operator's experience as well., Conclusions: Quality-control analysis for contemporary TAVI interventions based on standardized endpoints suggests the need for relevant operator's experience to achieve and maintain optimal clinical results, especially in higher-risk subjects.

Background: Coronary artery disease (CAD) is a common finding among patients undergoing trans-catheter aortic valve implantation (TAVI), who often present severely calcified coronary lesions. Evidence is scarce about the use of rotational atherectomy (RA) in this setting, in particular regarding long-term outcome., Methods: RA was performed on severely calcified coronary lesions concomitant with TAVI in a consecutive series of patients treated between 2010 and 2020. Immediate and long-term clinical outcomes are reported., Results: A concomitant CAD (coronary stenosis visually > 50%) was observed in 402/845 (47.6%) consecutive patients undergoing TAVI at the University Hospital of Verona. Angioplasty was performed in 104 patients (12.3%). Among these, 19 patients (18.3%, 20 coronary arteries), were treated with RA after TAVI: 10 after implantation of a balloon-expandable trans-catheter valve and 9 after a self-expandable valve. All procedures were successful. Hypotension occurred in 3 patients (15.8%), with rapid recovery after the procedure; CI-AKI (contrast-induced acute kidney injury) in 3 patients (15.8%), of which two recovered within discharge. At a median follow-up of 21.5 months (Q1-3: 6-36) event free survival was 83.3%. Only one patient suffered a target vessel failure >2 years after RA. Neither stroke nor peri-procedural infarctions were detected., Conclusions: RA concomitant with TAVI was feasible and safe in patients treated with implantation of either self-expandable, or balloon-expandable trans-catheter aortic valves. Long-term clinical events related to the coronary procedure were extremely infrequent and the survival rate at median follow-up of 21.5 months was 83.3%.

Long-term variations of fractional flow reserve (FFR) and instantaneous wave-free-ratio (iFR) after transcatheter aortic valve implantation (TAVI) have not been previously assessed. A total of 23 coronary lesions in 14 patients with aortic stenosis (AS) underwent physiology assessment at baseline, immediately after TAVI and at 14(7-29) months of follow-up. The angiographic severity of the lesions did not progress at follow-up (54[45-64] vs 54[49-63], p = .53). Overall, FFR (0.87[0.85-0.92] vs 0.88[0.82-0.92], p = .45) and iFR (0.88[0.85-0.96] vs 0.91[0.86-0.97], p = .30) did not change significantly compared with the baseline. FFR decreased in 3(13%) lesions with abnormal baseline value, whereas it remained stable in lesions with FFR > 0.80. Conversely, iFR did not show a systematic trend at long-term after TAVI. However, iFR demonstrated a higher reclassification rate at follow-up compared with FFR (p = .02). In conclusions, in this exploratory study, only minor variations of coronary physiology indices were observed at long-term after TAVI. Nevertheless, caution should be exercised in the interpretation of borderline FFR and iFR values in severe AS., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Cardiac allograft vasculopathy (CAV) is a unique form of accelerated atherosclerosis that represents the main late cause of morbidity and mortality, affecting almost half patients at ten years after heart transplantation (HTx). Unless the pathogenesis of CAV is still not completely understood, it seems to be the result of a complex interplay between immunological and non-immunological factors that induce endothelial injury. Histologically epicardial and intramural vessels present a concentric circumferential intimal thickening caused by smooth muscle cell proliferation, inflammatory cells, and lipid deposition. Coronary angiography is still considered the gold-standard diagnostic tool for CAV detection but has reduced sensibility due to its inability to visualize beyond the arterial lumen. Intravascular ultrasound (IVUS) allows detecting early intimal thickening with high sensitivity. Plaque composition and vulnerability, detectable with virtual histology (VH/IVUS), and optical coherence tomography (OCT) seem to relate to adverse clinical events. Treatment approaches continue to evolve, but prevention and early detection remain the focus. Mammalian target of rapamycin inhibitors can significantly delay the development and the progression of CAV, but their optimal use remains to be established. New encouraging results come from monoclonal autoantibodies. At present percutaneous revascularization procedures seem to have only a palliative meaning, with no clear evidence of survival advantage over medical therapy and should be considered in case of a focal disease. Drug-eluting stents have proven to reduce in-stent restenosis, with a potential role of imaging-guided intervention in this setting. Heart re-transplantation is the only resolutive therapy and is considered in the case of CAV associated with graft dysfunction., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background Differences in the impact of contrast medium on the development of contrast-induced acute kidney injury (CI-AKI) in patients undergoing transcatheter aortic valve implantation (TAVI) or a coronary angiography/percutaneous coronary intervention (CA/PCI) have not been previously investigated. Methods and Results Patients treated with TAVI or elective CA/PCI were retrospectively analyzed in terms of baseline and procedural characteristics, including preprocedural and postprocedural kidney function. CI-AKI was defined as a relative increase in serum creatinine concentration of at least 0.3 mg/dL within 72 hours of contrast-medium administration compared with baseline. The incidence of CI-AKI in the TAVI versus CA/PCI group was compared. After the exclusion of patients in dialysis and emergency procedures, 977 patients were analyzed; there were 489 patients who had undergone TAVI (50.1%) and 488 patients who had undergone CA/PCI (49.9%). Patients treated by TAVI were older, presenting a higher rate of anemia and chronic kidney disease ( P <0.001 for all comparisons). Consistently, they also had a significantly lower glomerular filtration rate and higher serum creatinine concentration ( P <0.001 for all). However, the occurrence of CI-AKI was significantly lower in these patients compared with patients treated by a CA/PCI (6.7% versus 14.5%, P <0.001). At multivariate analysis, the TAVI procedure had an independent protective effect on CI-AKI incidence among total population (odds ratio, 0.334; 95% CI, 0.193-0.579; P <0.001). This observation was confirmed after propensity score matching among 360 patients (180 by TAVI and 180 by CA/PCI; P =0.002). Conclusions CI-AKI occurred less frequently in patients undergoing TAVI than in patients undergoing a CA/PCI, despite a worse-risk profile. The impact of contrast administration on kidney function in patients who had undergone TAVI may be better tolerated because of the hemodynamic changes following aortic valve replacement.

Background: QRS axis deviation can occur during myocardial infarction (MI); to date, little is known about the significance of extreme right axis deviation (ERAD) in the frontal plane, i.e. a shift in QRS axis between +180° and +270°, during MI. We sought to investigate the clinical characteristics and outcomes of patients with new-onset ERAD in the absence of complete bundle branch blocks (BBB) in the setting of acute coronary syndromes (ACS)., Methods: A single-center retrospective observational study was conducted, including patients with new-onset ERAD in the absence of complete BBB admitted for ACS to our Cardiac Intensive Care Unit. Clinical, electrocardiographic, echocardiographic, angiographic features at baseline and cardiovascular events during hospitalization and at mid-term follow-up were collected., Results: The study population consisted of 30 consecutive patients (23 men) from January 2014 to September 2018. The most frequent clinical presentation was ST-segment elevation MI (n = 22, 73.4%) and the most frequent electrocardiographic MI location was anterolateral (n = 11, 36.7%). Left anterior descending (LAD) was the most frequent infarct-related artery (n = 21, 70%); 15 patients (50%) had multivessel coronary artery disease. Cardiac arrest due to ventricular fibrillation (VF) at presentation (n = 5, 16.6%), cardiogenic shock during the hospital stay (n = 10, 33.3%), cardiac arrest due to VF after revascularization (n = 6, 20%) and cardiac death (n = 7, 23.3%) were common., Conclusion: New-onset ERAD during MI may be related to extensive myocardial ischemia and/or necrosis causing an "electrical escaping" with an extreme dislocation of the QRS axis. In our limited series we found several acute arrhythmic and hemodynamic complications and high mortality., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: Little is known on the impact of contrast-induced acute kidney injury (CI-AKI) on mid- and long-term renal function after percutaneous coronary procedure. The aim of the study was to investigate the incidence of persistent renal damage (PRD) after CI-AKI in a cohort of patients undergoing coronary angiography and/or intervention. Moreover, we sought to assess the predictive value of small creatinine change at 12-24 h (SCrΔ%12-24 h) from contrast exposure in predicting CI-AKI and PRD., Methods: Complete clinical and biochemical data of 731 patients were retrospectively analyzed at sequential time intervals at baseline, 12-24 h and 48-72 h from the procedure. Data at 30 ± 10 days and 12-24 months were available in 59% and 49% of the cases respectively. Logistic regression was used to assess variables associated with CI-AKI and PRD. ROC analysis was used to test the diagnostic accuracy of SCrΔ%12-24 h in predicting CI-AKI and PRD., Results: CI-AKI occurred in 130/731 patients (17.8%). At 30 ± 10 days PRD occurred in 54.8% patients who developed CI-AKI. A SCrΔ%12-24 h >5% demonstrated independent predictive value (OR = 1.05, CI = 1.04-1.06, p < 0.001) and fair accuracy (AUC = 0.80, CI = 0.77-0.84) for CI-AKI., Conclusion: CI-AKI was associated with PRD in >50% of the cases in this single centre cohort. A small and early SCrΔ%12-24 h demonstrated high predictive value for CI-AKI and may be used as a useful tool to unmask a group of patients at risk for PRD after percutaneous coronary procedures., Competing Interests: Declaration of Competing Interest None., (Copyright © 2019 Elsevier Inc. All rights reserved.)

The reliability of fractional flow reserve (FFR) in aortic stenosis (AS) has been questioned because of the uncertain response to vasodilators. A retrospective multicenter cohort of 114 AS patients who underwent coronary physiology assessment was compared with 154 controls before and after propensity matching adjustment. The difference between resting distal coronary vs aortic pressure ratio (Pd/Pa) and FFR (ΔPd/Pa-FFR) was tested against the severity of AS. ΔPd/Pa-FFR was not influenced by the severity of AS in terms of aortic valve area (r = - 0.02, p = 0.83) and gradient (r = - 0.05, p = 0.64) or by the left ventricle hypertrophy (r = - 0.03, p = 0.88). Conversely, ΔPd/Pa-FFR was influenced by the presence of diabetes (r = - 0.24, p = 0.005), peripheral vascular disease (r = - 0.16, p = 0.047), and chronic kidney disease (r = - 0.19, p = 0.03). No significant difference was observed in the ΔPd/Pa-FFR between patients with AS and matched controls. Further studies are warranted to validate the FFR-guided revascularization in patients with AS.

Background Management of coronary artery disease in patients undergoing transcatheter aortic valve implantation is uncertain. Fractional flow reserve (FFR) has never been clinically validated in aortic stenosis. The study aim was to analyze the clinical outcome of FFR-guided revascularization in patients undergoing transcatheter aortic valve implantation. Methods and Results Patients with severe aortic stenosis and coronary artery disease at coronary angiography were included in this retrospective analysis and divided in 2 groups: angiography guided (122/216; 56.5%) versus FFR-guided revascularization (94/216; 43.5%). Patients were clinically followed up and evaluated for the occurrence of major adverse cardiac and cerebrovascular events at 2-year follow-up. Most lesions in the FFR group resulted negative according to the conventional 0.80 cutoff value (111/142; 78.2%) and were deferred. The FFR-guided group showed a better major adverse cardiac and cerebrovascular event-free survival compared with the angio-guided group (92.6% versus 82.0%; hazard ratio, 0.4; 95% CI, 0.2-1.0; P =0.035). Patients with deferred lesions based on FFR presented better outcome compared with patients who underwent angio-guided percutaneous coronary intervention (91.4% versus 68.1%; hazard ratio, 0.3; 95% CI, 0.1-0.6; P =0.001). Conclusions FFR guidance was associated with favorable outcome in this observational study in patients undergoing transcatheter aortic valve implantation. Randomized trials are needed to investigate the long-term effects of FFR-guided revascularization against angiographic guidance alone in patients with aortic stenosis.

Background: Aortic stenosis (AS) is frequently associated with coronary artery disease (CAD). However, the best tool to functionally assess CAD in AS remains undetermined. Fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) have never been validated in AS., Methods: FFR, iFR and stress single photon emission computed tomography (SPECT) were performed in a consecutive series of 28 patients with severe AS and 41 borderline coronary lesions during the work-up for valve replacement., Results: Both FFR and iFR were correlated with an abnormal SPECT. At ROC analysis, FFR yielded an AUC = 0.91 with negative predictive value (NPV) = 95% in detecting ischemia according to SPECT. iFR showed significant worse agreement with myocardial perfusion imaging compared to FFR (59% vs 85%, p = 0.014). Specifically, a significant larger proportion of false positive measurements (negative SPECT and iFR < 0.89) was observed using iFR vs FFR: 39% vs 12%, p = 0.011. Using a pre-specified 0.82 cut-off, the iFR agreement with SPECT increased to 73%., Conclusions: FFR yielded a good correlation with SPECT and a high NPV in detecting ischemia-provoking lesions. iFR diagnostic metrics were inferior compared with FFR and improved adopting a lower ischemic threshold., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Radial artery occlusion (RAO) is a thrombotic complication of transradial catheterization that can lead to permanent occlusion of the radial artery. Sheath-vessel diameter ratio, postprocedure compression time, occlusive hemostasis, and insufficient anticoagulation are all predictors of RAO. However, excessive anticoagulation can lead to longer time to achieve complete hemostasis and less patent hemostasis rate. This study was designed to assess the relationship among residual anticoagulation at the end of a percutaneous coronary procedure and the risk of RAO., Methods: Eight hundred thirty-seven patients undergoing transradial catheterization were enrolled. Activated clotting time (ACT) was measured before sheath removal. Patients were divided into 3 groups according to ACT values (ACT <150 s, ACT between 150 and 249 s, ACT >250 s), patent hemostasis with reverse Barbeau test was attempted in all patients, and compression device removed as soon as possible. Within 24 hours, patency of radial artery was checked by Doppler using reverse Barbeau technique., Results: Incidence of RAO was higher for the extreme ACT values. Patent hemostasis were less frequently obtained and time to hemostasis significantly longer for increasing ACT values ( P =0.004 for trend and <0.0001 for trend, respectively). At logistic regression analysis, ACT values <150 s were an independent predictor of RAO (odds ratio, 3.53; 95% IC, 1.677-7.43; P =0.001) while adjusted probability for RAO confirmed U-shaped relationship with ACT values., Conclusions: The level of anticoagulation is strongly related to incidence of RAO and should be measured objectively by ACT., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02762344.

Cardiogenic shock (CS) is a low cardiac-output state resulting in end-organ hypoperfusion and hypoxia that if untreated leads to an irreversible condition of multi-organ failure. Acute coronary syndrome (ACS) is the most common cause of CS, with a high prevalence of patients with multi vessels disease. Cardiogenic shock management remains a challenge since mortality rates are still high and have not declined over the last 20 years. The treatment strategy of CS in patients with ACS needs to take into account both the presence of myocardial ischemia and tissue hypoperfusion. The first part of the review will focus on the characteristics, the hemodynamic profile and the evidence available of the mechanical circulatory support devices for an optimal patient-device matching. The second part will focus on the management strategy of CS in terms of myocardial revascularization and hemodynamic support in light of the most recent available evidence.

Objectives: The aim of this study is to assess long-term-outcomes of patients with concomitant CAD and COD treated with different revascularization strategies., Background: Multisite artery disease is common and patients with combined disease have poor prognosis. The best therapeutic strategy for patients with concomitant carotid obstructive disease (COD) and coronary artery disease (CAD) remains controversial., Methods: This observational registry enrolled, between January 2006 and December 2012, 1022 consecutive patients from high volume institutions with concomitant CAD and COD suitable for endovascular, surgical, or hybrid revascularization in both territories selected by consensus of a multidisciplinary team., Results: The cumulative incidence of 5-year major cardiovascular events (MACCE) including cardiovascular death, myocardial infarction (MI), or stroke in the overall population was 12%. The incidence of 5-year MACCE was not statistically different in the surgical, endovascular, or hybrid patients group (10.1% vs. 13.0% vs. 13.2%, P = .257, respectively). However, the hybrid group exhibited rates of myocardial infarction, chronic kidney disease, and cumulative incidence of all clinical events higher than the surgical group. After propensity score matching, the incidence of 5-year MACCE was similar in the three groups (13.0% vs. 15.0% vs. 16.0%, p = .947, respectively)., Conclusions: An individualized revascularization approach of patients with combined CAD and COD yields very good results at long-term follow-up, despite the high risk of this multilevel population even when the baseline clinical features are equalized., Competing Interests: The authors declare that there is no conflict of interest regarding the publication of this article., (Copyright © 2019 Fabrizio Tomai et al.)

Objective: To investigate the effect of extent of revascularization in complex high-risk indicated patients (CHIP) undergoing Impella-protected percutaneous coronary intervention (PCI)., Background: Complete revascularization has been shown to be associated with improved outcomes. However, the impact of more complete revascularization during Impella-protected PCI in CHIP has not been reported., Methods: A total of 86 CHIP undergoing elective PCI with Impella 2.5 or Impella CP between April 2007 and December 2016 from 2 high volume Italian centers were included. Baseline, procedural, and clinical outcomes data were collected retrospectively. Completeness of coronary revascularization was assessed using the British Cardiovascular Intervention Society myocardial jeopardy score (BCIS-JS) derived revascularization index (RI). The primary end-point was all-cause mortality. A multivariate regression model was used to identify independent predictors of mortality., Results: All patients had multivessel disease and were considered unsuitable for surgery. At baseline, 44% had left main disease, 78% had LVEF ≤ 35%, and mean BCIS-JS score was 10±2. The mean BCIS-JS derived RI was 0.7±0.2 and procedural complications were uncommon. At 14-month follow-up, all-cause mortality was 10.5%. At follow-up, 67.4% of CHIP had LVEF ≥ 35% compared to 22.1% before Impella protected-PCI. Higher BCIS-JS RI was significantly associated with LVEF improvement (p=0.002). BCIS-JS RI of ≤ 0.8 (HR 0.11, 95% CI 0.01- 0.92, and p = 0.042) was an independent predictor of mortality., Conclusions: These results support the practice of percutaneous Impella use for protected PCI in CHIP. A more complete revascularization was associated with significant LVEF improvement and survival., Competing Interests: Dr. Burzotta discloses to have been involved in advisory board meetings or having received speaker's fees from Medtronic, St Jude Medical, Abiomed, Biotronic. Dr. Trani discloses to have been involved in advisory board meetings or having received speaker's fees from St Jude Medical, Abiomed, Biotronic. Dr. Aurigemma has been involved in advisory board activities by Biotronic. The remaining authors have nothing to disclose., (Copyright © 2019 Francesco Burzotta et al.)

Background: Percutaneous ventricular-assistance by Impella (IMP) represents an emerging strategy to manage patients with reduced left-ventricular (LV) ejection-fraction (EF) undergoing percutaneous-coronary-intervention (PCI). The hemodynamic behave during IMP-protected PCI has been scarcely investigated., Methods: We reviewed the IMP console's function and hemodynamic data (which are continuously recorded during assistance) in a consecutive series of 37 patients who underwent elective IMP-protected PCI in two high-volume centers. All patients had multivessel disease and impaired LVEF. Coronary artery disease burden was graded using the British-Cardiovascular-Intervention-Society jeopardy-score (BCIS-JS) score. IMP motor speed and pressure signals (systolic blood pressure, SBP, and mean blood pressure, MBP) were analyzed. Primary hemodynamic end-points were "critical systolic blood pressure (SBP) drop" (SBP decrease ≥ 20 mm Hg reaching ≤90 mm Hg values) and "critical mean blood pressure (MBP) drop" (MBP decrease reaching ≤60 mm Hg)., Results: Over mean assistance duration of 254 ± 549 min, no IMP motor drop occurred. During PCI, SBP and MBP significantly decreased but all patients had SBP values >78 mm Hg. Critical SBP and MBP drops occurred in 10.8% of patients. Among all baseline and procedural characteristics, BCIS-JS was the only significant predictor of SBP drop (p = 0.001) while BCIS-JS and LV end-diastolic volume significantly predicted MBP drop (p = 0.001 for both)., Conclusions: In patients with reduced EF undergoing IMP-protected PCI, a significant pressure decrease occurs during PCI but pressure is systematically maintained at levels warranting vital organ perfusion. Critical pressure drops during PCI occur in some patients with higher jeopardized myocardium and left ventricular diastolic volumes., (Copyright © 2018 Elsevier B.V. All rights reserved.)

The ability of interventional cardiologists to identify high-risk percutaneous coronary intervention (PCI) patients, requires the integration of different features belonging to medical history, organ damage, coronary anatomy and the nature of the acute event. The selection of a subgroup of patients that could benefit from mechanical support during interventions is a key feature to success. The introduction of the Impella percutaneous axial pump have added an easy-to-set-up, less invasive and time-consuming active-support device to the interventional toolbox. Up to date, only few (four) randomized clinical trials (RCTs) have tried to address the clinical efficacy of Impella assistance for the treatment of this very high-risk population, but several large registries and multiple observational studies have demonstrated its safety, feasibility and hemodynamic performance. Although the largest RCT (PROTECT II) have been prematurely stopped due to the risk of futility despite the evidence of more complete revascularization in the Impella arm, the need for an adequate operator's learning curve must be considered. More recent insights suggest an effect of the device in optimizing end-organ perfusion and improving crucial parameters like renal function. Furthermore, available data suggest that vary early Impella support may improve patient's outcome in case of cardiogenic shock.

Background: The complexity of coronary physiology in presence of severe aortic stenosis (AS) raises concerns about the reliability of pressure-derived indexes in this clinical setting. Furthermore, neither fractional flow reserve (FFR) nor instantaneous wave-free period (iFR) has been validated in AS. Combining iFR and FFR in a tailored decision-making strategy may help to increase simplicity, accuracy and safety of physiology-guided revascularization in AS., Methods: In this prospective observational study iFR and FFR were measured before and after TAVI during the same procedure in patients with severe AS and concomitant coronary artery disease (CAD). All decisions about revascularization were based on post-TAVI FFR assessment. The best iFR "defer" and "treatment" values were identified according to their baseline negative (NPV) and positive predictive values (PPV) respectively. A post-hoc analysis was then performed to compare the hybrid iFR-FFR approach with the FFR-only strategy., Results: Sixty-two patients underwent pre- and post-TAVI pressure-wire assessment and were included in the analysis. A "defer iFR value" >0.93 yielded a NPV of 98.4% (91.7%-99.9%) to exclude FFR non-significant stenosis (>0.80), and a "treatment iFR value" <0.83 had a PPV of 91.3% (72%-98.9%) to identify FFR-significant stenosis (≤0.80). A hybrid decision-making strategy based on iFR and FFR spared 63% of patients from adenosine, while maintaining 97% overall agreement with FFR lesions classification., Conclusion: A hybrid iFR-FFR diagnostic strategy is feasible and safe in patients with severe AS undergoing TAVI and allows to spare the majority of patients from adenosine, while maintaining a high agreement with FFR classification of coronary lesions., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Results of transcatheter aortic valve implantation (TAVI) for treatment of severe noncalcific isolated aortic regurgitation (AR) complicated by advanced heart failure or cardiogenic shock has been previously reported only in isolated case reports. Current self-expanding transcatheter aortic valves are designed to treat aortic valve stenosis, and have also been implanted in cases of severe AR due to degenerated bioprosthesis and in very few cases of native aortic valves. We report 13 consecutive inoperable patients with noncalcific, pure AR, and advanced heart failure treated with emergency percutaneous transfemoral implantation with self-expandable CoreValves at our institution between July 2012 and September 2017. The immediate and long-term clinical outcome was prospectively assessed according to the Valve Academic Research Consortium-2 criteria for device success and safety. All but 3 patients had previous surgery of the aortic root, including 2 implants of Heart Mate-II left ventricle assist device; none had surgical aortic bioprosthesis at the time of the TAVI. Valve implantation was successful in 12 of 13 patients (92%) and 1 patient required a second unplanned valve procedure within 18 hours. Oversizing the prosthesis by approximately 15% yielded better results with 1 valve. Two patients with left ventricle assist device died within 30 days of TAVI. All patients who survived to hospital discharge had none or just mild residual AR, improved their cardiac function, and survived at long-term without recurrence of clinical events. In conclusion, implanting self-expandable transcatheter valves in patients pure AR in this small study was safe and effective, and represented an important option for inoperable patients with noncalcific severe AR., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Aims: We sought to assess eventual changes in iFR measurements in patients with aortic stenosis (AS) before and after TAVI in coronary lesions with different degrees of angiographic severity., Methods and Results: The functional relevance of 145 coronary lesions was assessed by online iFR and FFR measurement in 66 patients with severe AS before and after TAVI, during the same procedure. The iFR-FFR classification agreement was calculated for pre-TAVI and post-TAVI measurements. Mean iFR values remained identical before and after TAVI, irrespective of the angiographic severity of the coronary stenosis (0.89±0.12 vs. 0.89±0.12, p=0.66). However, individual iFR values varied widely after TAVI and the 0.89 iFR threshold was crossed by 15% of the investigated coronary lesions. Higher iFR variation was related to a higher transaortic gradient drop after valve intervention. The diagnostic accuracy of iFR in predicting an FFR ≤0.8 was poor (65%) in lesions with severe obstructions, and tended to increase post TAVI., Conclusions: Although overall values did not change after TAVI, iFR presented significant and mostly erratic individual variations after valve replacement. Delta iFR was influenced by the extent of the transaortic gradient drop induced by TAVI. Therefore, caution is advisable in the interpretation of iFR in the presence of AS.

Background: The functional assessment of coronary artery disease (CAD) in patients with aortic stenosis (AS) has not been validated so far, and the best strategy to physiologically investigate the relevance of coronary stenosis in this specific setting of patients remains undetermined. The aim of the study is to compare the diagnostic performance of instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) in patients with severe AS., Methods: The functional significance of 179 coronary lesions was investigated with on-line iFR and FFR measurements in 85 AS patients and compared with a control group formed by 167 patients (290 lesions) with stable CAD and without AS. The iFR-FFR diagnostic agreement has been tested using the conventional 0.80 FFR cut-off., Results: The correlation between iFR and FFR was similar between AS and CAD patients, as well as the area under the curve at ROC curve analysis (0.97 vs 0.96, p=0.88). However, using the standard iFR 0.89 threshold, the diagnostic accuracy of iFR was significantly lower in AS compared with CAD (76.3% vs 86.1%, p=0.009). According to ROC analysis, the best iFR cut-off in predicting FFR≤0.8 was lower in AS (0.83, J=0.82) compared with CAD (0.89, J=0.81). Using the ROC derived cut-off of 0.83, the iFR accuracy increased significantly (91.3%, p=0.003) while maintaining an elevated negative predictive value (95.5%)., Conclusions: In the presence of severe AS, conventional iFR cut-off had lower diagnostic agreement with FFR classification of coronary lesions compared to stable CAD patients. AS seems to influence iFR cut-off ischemic thresholds and deserves further comparative studies., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

Coronary artery disease (CAD) is often present in patients with severe aortic valve stenosis candidates to transcatheter aortic valve implantation (TAVI). Mild CAD may also worsen and need treatment years after TAVI. The implantation of a transcatheter valve may interfere with the capability of reengaging the coronary arteries. We prospectively assessed the feasibility of performing coronary angiography (CA), fractional flow reserve, and, where indicated, percutaneous coronary intervention after valve implantation in a consecutive series of patients with CAD undergoing TAVI. Valve type and size were decided according to accurate computed tomography scan and angiographic measurement of the aortic root structures. We analyzed 66 consecutive patients undergoing TAVI, 41 with balloon-expandable, and 25 with self-expandable transcatheter valves. Right and left coronary catheterization (132 vessels) was successful in all cases except in 1 left coronary artery after a high implantation of a self-expandable valve (unsuccess rate, 1 in 50 vessels). In 6 of 132 vessels (4%), CA was initially nonselective, but after positioning the 0.014″ intracoronary guidewire, selective injections were obtained in all these cases. Percutaneous coronary intervention was performed successfully in 19 coronary vessels (17 patients) as indicated by fractional flow reserve measurements. In conclusion, catheterization of the coronary ostia after transfemoral TAVI with balloon or self-expandable valves is safe and feasible in almost all cases. Accurate imaging of the aortic root and procedural planning may help to avoid too high implantation of supra-annular self-expandable valves to obviate difficulties in accessing coronary ostia. Use of intracoronary guidewires facilitates selective CA in cases with difficult access., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Transcatheter tricuspid VIV replacement has been proposed as a feasible option for high-risk patients with previous tricuspid valve replacement that undergo valve degeneration causing refractory heart failure. However, little is known about the long-term outcome of patients treated with transcatheter tricuspid VIV. We evaluate the safety of transcatheter tricuspid valve-in-valve (VIV) replacement by using balloon-expandable aortic valve stents and the long-term follow-up., Methods and Results: From January 2013 to March 2016, 4 patients underwent transcatheter tricuspid VIV in our center using balloon-expandable Edwards Sapien-XT and Sapien-3 valves. In all cases the procedure succeeded with significant improvement of the tricuspid valve area (from 0.98±0.29cm 2 to 3.1±0.45cm 2 , p=0.005), right atrial pressure (from 21±7.78mmHg to 8.5±2.51mmHg, p=0.025) and mean trans-valvular gradient (from 11.5±4mmHg to 3.32±1.28mmHg, p=0.02). Three out of 4 patients presented a follow up longer than 2.5years. At median follow up of 32months (range 9-47months) all patients were alive and presented with NYHA class I-II. Only one patient, who presented impaired right ventricular function at baseline, experienced re-hospitalization during the follow-up time. Echocardiographic assessment at long-term disclosed a well-maintained hemodynamic performance with low trans-valvular gradients and no significant valvular regurgitation in all cases., Conclusions: In our experience, trans-catheter tricuspid VIV demonstrated good long-term results in terms of valve performance and functional class improvement at 32months from intervention., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

The effect of a highly elevated level of right atrial filling pressure on fractional flow reserve (FFR) measurement remains unclear. Transcatheter tricuspid valve intervention, a recently introduced option for inoperable or high-risk patients, represents a unique model of in-vivo physiology to investigate the eventual influence of central venous pressure on coronary FFR measurements. The case is reported of a patient with a degenerated tricuspid surgical bioprosthesis who underwent transcatheter tricuspid valve-in-valve replacement and concomitant coronary functional assessment with FFR. In an experimental model, the significant fall in right atrial pressure did not influence FFR measurements in the presence of angiographically proven mild coronary artery disease.

Background: Aortic valve stenosis may influence fractional flow reserve (FFR) of concomitant coronary artery disease by causing hypertrophy and reducing the vasodilatory reserve of the coronary circulation. We sought to investigate whether FFR values might change after valve replacement., Methods and Results: The functional relevance of 133 coronary lesions was assessed by FFR in 54 patients with severe aortic valve stenosis before and after transcatheter aortic valve implantation (TAVI) during the same procedure. A linear mixed model was used to verify the interaction of TAVI effect with the FFR values. No significant overall change in FFR values was found before and after the aortic valve stenosis removal (0.89±0.10 versus 0.89±0.13; P=0.73). A different trend in FFR groups (positive if ≤0.8; negative if >0.8) was found after TAVI (P for interaction <0.001). Positive FFR values worsened after TAVI (0.71±0.11 versus 0.66±0.14). Conversely, negative FFR values improved after TAVI (0.92±0.06 versus 0.93±0.07). Similarly, FFR values in coronary arteries with lesions presenting percent diameter stenosis >50 worsened after TAVI (0.84±0.12 versus 0.82±0.16; P=0.02), whereas FFR values in arteries with mild lesions (percent diameter stenosis <50) tended toward improvement after TAVI (0.90±0.07 versus 0.91±0.09; P=0.69). Functional FFR variations after TAVI changed the indication to treat the coronary stenosis in 8 of 133 (6%) lesions., Conclusions: Coronary hemodynamics are influenced by aortic valve stenosis removal. Nevertheless, FFR variations after TAVI are minor and crossed the diagnostic cutoff of 0.8 in a small number of patients after valve replacement. Borderline coronary lesions might become functionally significant after valve replacement, although FFR-guided interventions were infrequent even in patients with angiographically significant lesions., (© 2016 American Heart Association, Inc.)

Objective: The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve., Methods: Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves., Results: 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to provide the acceptable margin of the composite end point of any death, stroke, myocardial infarction, life-threatening bleeding, major vascular complications, stage 2-3 acute kidney injury and valve-related dysfunction requiring a repeat procedure) required the performance of 54 cases, while the learning curve to achieve 'device success' identified 32 cases to reach the expected proficiency. In this experience, the baseline clinical risk as assessed by the Society of Thoracic Surgeons (STS) score determined the long-term survival rather than the adverse events related to the learning curve., Conclusions: A relatively large number of cases are required to achieve clinical outcomes comparable to those reported in high-volume centres and controlled trials. According to our national workload standards, this represents more than 2 years of continuous activity.

Background: The aim of this study was to evaluate the safety and efficacy of bioresorbable vascular scaffolds (BVS) in terms of acute success and long-term clinical events in a real world population according to the most updated technical recommendations., Methods: Perspective, single-center registry involving symptomatic patients treated with BVS from February 2013 to January 2016. Primary end-point was the occurrence of MACCEs at one year: death, target vessel related myocardial infarction, target vessel revascularization, stroke, major bleeding. Secondary endpoints were acute device and procedural clinical success, and occurrence of MACCEs at long-term follow-up., Results: In total, 112 patients were treated on 173 lesions. Average age was 55.53±12.4 years and acute coronary syndrome was the admission diagnosis for 79.5% patients. Nine patients presented cardiac allograft vasculopathy after cardiac transplantation. Multi-vessel disease was treated in 50% of cases. Predilatation and post-dilatation were performed respectively in 96% and 88.4% of lesions. Intravascular imaging was used in 41 patients (37%). Angiographic success rate and procedural success rate were 100% and 97.3% respectively. Clinical follow-up was completed in 100 patients with an average follow-up of 10.5±8.3 months. Including peri-procedural and in-hospital MACCEs, target vessel failure was noticed in 7% of patients in the first year of follow up and in 11% of patients at long-term follow-up. Two cases of target lesion revascularization occurred 25 and 26 months after the index procedure. No cases of definite stent thrombosis were reported., Conclusions: Strict adherence to expert recommendation for BVS placement may minimize device related peri-procedural and mid-to-long term MACCEs in a real world population.

Contrast-induced acute kidney injury (CI-AKI) after coronary angiography or interventions is relatively frequent and portends adverse outcomes. The lack of a "universally accepted" definition, however, limits the integration and comparison of available data. We aimed to detect the CI-AKI definition that best correlates with the occurrence of clinical events at long-term in a 3-year follow-up study of patients at intermediate-to-high risk for CI-AKI. Furthermore, we sought to describe the incidence and long-term evolution of persistent renal damage (PRD) after CI-AKI and clarify the role of early (<12 hours) increments of serum creatinine (SCr) in CI-AKI prediction. Among a total of 216 patients enrolled at our center and followed for a median of 37 months, CI-AKI was diagnosed in 18.1% of cases (SCr increment ≥25% of baseline), 7.4% (SCr increment ≥0.5 mg/dl), and in 17.1% (SCr increment ≥0.3 mg/dl), according to 3 different definitions. The third definition was the only one significantly associated with the occurrence of events at 3 years (Cox regression, p = 0.04). PRD at 30 days, as detected by the same cutoff, significantly and independently identified patients at risk of worst outcomes at 3 years (p = 0.04 at multivariate Cox regression). Furthermore, a slight 5% to 10% increment of SCr compared with baseline, occurring as early as 12 hours postprocedure, was confirmed as a strong predictor of inhospital CI-AKI occurrence. In conclusion, an absolute increase in SCr ≥0.3 mg/dl seems to be most clinically informative cutoff for CI-AKI and PRD detection., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Repeat myocardial revascularization procedures are markedly different from de novo interventions, with increased procedural risk and technical-demanding complexity. However the number of patients previously treated with coronary artery bypass graft (CABG) that need a repeat revascularization due to graft failure is increasing consistently. Late graft failure, usually caused by saphenous vein grafts (SVG) attrition, is certainly not uncommon. However PCI on degenerated SVG presents higher complication rate and worse clinical outcome compared with native arteries interventions. In acute graft failure setting, PCI represents a valuable option to treat postoperative myocardial infarction., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Pulmonary hypertension (PH) is often found in cystic fibrosis (CF) patients affected by end-stage lung disease but its impact on outcome remains unclear. Pulmonary arterial compliance (PAC) is an important determinant of right ventricle (RV) workload and it is a strong predictor of survival in other forms of PH. The aim of this study is to investigate whether PAC is a predictor of long-term prognosis in a population of CF patients affected by advanced lung disease., Methods: Between 2000 and 2014, 178 patients with CF have been evaluated for lung transplantation in our CF Center. Right heart catheterization (RHC) and follow up data were retrievable and analyzed in 141 of them. PAC was defined as the ratio between stroke volume (SV) and pulse pressure (PP) at heart catheterization. The association of PAC with survival was tested at 4 years and compared to other hemodynamic parameters., Results: PH prevalence was 56.4%. Most patients had mild elevation of pulmonary artery pressure (PAP). No difference in mortality was observed in patients with PH compared to patients with normal PAP (HR 0.95: 95% CI 0.49-1.89, p=0.89). At receiver operating characteristic curve (ROC) analysis, the optimal prognostic cut-off point of PAC was 1.95 ml/mmHg. An impaired PAC (≤1.95 ml/mmHg) was a strong independent predictor of long-term mortality (HR 3.44: 95% CI 1.51-7.85: p=0.003)., Conclusions: Impaired PAC is associated with poor prognosis in CF patients awaiting lung transplantation. Other traditional hemodynamic parameters add no prognostic information., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Aims: To compare the performance of instantaneous wave-free ratio (iFR) with fractional flow reserve (FFR) in a real-life, prospective, single-center, and independent study., Methods and Results: Fifty-four patients were included and 89 angiographic intermediate lesions underwent functional evaluation with both iFR and FFR. FFR was used as the gold standard, and the patients having FFR values 0.80 or less only underwent percutaneous coronary intervention. Linear regression demonstrated close agreement between the two techniques (R = 0.83, P < 0.0001). Receiver operator characteristic analysis confirmed the strong correlation, with an area under the curve approximately equal to unity. iFR detected ischemia with a sensitivity and specificity of 100 and 87%, respectively, thus revealing a positive predictive value of 78% and a negative predictive value of 100%. In addition, according to FFR assessment, percutaneous coronary intervention was performed on 39 lesions (43.8%) in 27 patients (50%), whereas positive iFR values were found in 52 lesions (+14.6% compared with FFR). At clinical follow-up (ranging from 6 to 16 months), all patients remained asymptomatic and none of them experienced major adverse cardiovascular events., Conclusions: In this independent, online, comparison of iFR-FFR values in patients with angiographic intermediate lesions, results are consistent with those derived from previous offline controlled trials, and support the correlation between iFR and FFR in daily clinical practice.

Objective: This study analyses dynamicchangesin dispersion of ventricularrepolarization over the time course of takotsubo cardiomyopathy (TC), and their relationships with clinical features and life-threatening arrhythmias., Methods and Results: All consecutive patients admitted to our division between January 2008 and December 2011 with a diagnosis of TC were analysed. Patients with prior myocardial infarction, symptoms-onset-to-admission time greater than 12 hours, an implanted pacemaker, or under treatment with drugs affecting QTinterval, were excluded. Standard 12-lead ECG recordings during the acute, subacute and chronic phases were collected for each patient. Twenty-four patients (23 women, 63 +/- 14 years) were includedin our analysis. Only one patient experienced ventricular arrhythmias (4.2%). Significant increases were observed in QT and QTc intervals (from 420 ?423 to 505 +/- 66 ms, P < 0.00001, and from 479 +/- 33 to 551 +/- 51 ms, P < 0.00001, respectively), QTdispersion (from 59 +/- 18 to 100 +/- 44 ms, P=0.0006), Tpeak-to-Tend (from 82 +/- 20 to 123 +/- 39 ms, P=0.00006) and Tpeak-to-Tend/QT (from 0.20 +/- 0.33 to 0.26 +/- 0.57, P=0.0003) during the subacute phase. All these parameters returned to baseline values in the chronic phase and did not show any significant differences between the acute and chronic phases., Conclusions: A marked increase in QTc, QT dispersion, Tpeak-to-Tend and Tpeak-to-Tend/QT was observed during the subacute phase; this increase was transient and reverted in allpatients before hospital discharge. Ofnote, these findings were not associated with an increased risk of life-threatening arrhythmias.

Background: The aim of this study was to compare ECG findings between anterior ST elevation myocardial infarction (STEMI) and Takotsubo cardiomyopathy (TC) in a similar sample of postmenopausal women., Methods: Between 2008 and 2011, 27 patients with TC were retrospectively enrolled and matched with 27 STEMI patients with the same age and sex taken from the prospective database of our laboratory., Results: The absence of abnormal Q waves, the ST depression in aVR and the lack of ST elevation in V1 were significantly associated with TC (respectively: 52% vs 18%, p=0.01; 47% vs 11%, p=0.01; 80% vs 41%, p=0.01). The combination of these ECG findings identified TC with a specificity of 95% and a positive predictive value of 85.7%., Conclusions: The ECG on admission may be useful to distinguish TC from anterior STEMI. The combination of three ECG findings identifies patients with TC with high specificity and positive predictive value., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Renal sympathetic denervation (RSD) is emerging as a new therapeutic option for patients with severe hypertension refractory to medical therapy. Patients affected by renovascular or anatomical abnormalities have hitherto been systematically excluded from clinical trials with RSD because of concern about safety and the unknown efficacy of the procedure in this subgroup of patients. We describe the management of a case of RSD in a single-kidney patient with refractory hypertension; the patient had had a previous surgical right nephrectomy for renal cell carcinoma that subsequently required no other oncologic treatment. After multidisciplinary assessment, the patient underwent RSD. The procedure was performed through a 6F femoral access using the Symplicity™ RSD system (Medtronic, Mountain View, CA, USA). Radiofrequency was applied to the renal artery wall in 6 different points under general sedation with midazolam to control back pain caused by the procedure, that was performed without periprocedural complications. The patient was discharged 2 days later after a control of the vascular access site and routine biochemical examinations. The following 9-month follow up showed a significant reduction in blood pressure and stable renal function, without signs of renal damage. Our report confirms the feasibility of RSD in this delicate context, without evident negative effects on kidney function and with a significant reduction in blood pressure. Future studies are needed to fully clarify the value of RSD in single-kidney patients.

Left ventricular assistance with surgically implanted pump devices like the HeartMate may be crucial in selected patient with end-stage heart failure. However, mainly due to its high aortic output, the pump itself may induce severe aortic regurgitation that could result in paradoxycal worsening of the anterograde perfusion after the initiation of the support. Surgical or percutaneous occlusion of the aortic valve has proved useful in these kinds of patients. Here we present a successful case of bail-out CoreValve implantation after HeartMate II positioning complicated by acute severe aortic regurgitation in a patient with a failing homograft and end-stage ventricular dysfunction, ineligible for heart transplanation., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Acute coronary syndromes (ACS) represent a life-threatening complication of the systemic atherosclerotic process, affecting the coronary circulation. Thrombosis, defined as an uncontrolled activation of the endogenous thrombogenetic reparative process, often follows atherosclerotic plaque damage and is mainly engaged by two main pathways: platelet aggregation and coagulation. Therefore, antithrombotic therapy to modulate either pathway plays an important role for the reduction of ischaemic adverse events in ACS patients. Since the advent of aspirin and warfarin, numerous antiaggregant and anticoagulant molecules have been developed to achieve this goal, but their anti-ischaemic efficacy is often obtained at the price of augmented bleedings, which are known to be strong predictors of adverse outcome. This article briefly reviews the physiopathological mechanisms of thrombosis and presents an overview of the available literature supporting the use of these major drugs, as well as the European Society of Cardiology recommendations for their utilisation in the setting of non-ST and ST-elevation myocardial infarction undergoing invasive treatment., Competing Interests: Disclosure: The authors have no conflicts of interest to declare.

Catheter-based treatment of aortic regurgitation (AR) often proves challenging especially due to associated anatomical difficulties. Here, we present a case of CoreValve implantation with a novel use of the valve-in-valve technique to effectively treat severe AR in a patient with repeated cardiac surgery and aneurismatic prosthetic ascending aorta., (Copyright © 2013 Wiley Periodicals, Inc.)

Background and Objective: Late and very-late stent occlusion remains a serious complication of coronary stenting. Despite their high anti-restenotic efficacy, drug-eluting stents (DES) have been associated to more late-thrombosis as compared to bare-metal stents (BMS). The aim of this study is to analyze the clinical presentation, angiographic, and intravascular ultrasound (IVUS) findings in patients with late or very late stent thrombosis and the relationship with the antiplatelet regimen., Methods and Results: Between January 2007 and December 2011, 34 consecutive patients with clinical syndromes compatible with late or very-late stent occlusion were studied with IVUS during emergency catheterization; 25 had DES and 9 had BMS. Thrombotic total occlusion was more common in DES (16 = 64%) than BMS patients (2 = 22%; P = 0.02) and ST-segment elevation myocardial infarction was the predominant clinical presentation in the former group (60% compared to 22%; P = 0.05). The time elapsed between implantation and failure was much longer in DES patients: 33 ± 22 versus 17 ± 14 months for BMS; P = 0.05. IVUS analysis showed a higher incidence of incomplete stent apposition (ISA) in the DES group compared to the BMS group (56% vs. 11%; P = 0.005) and in-stent plaque rupture was the most common finding in the BMS group (78%). In DES group, ISA was found more frequently in patients still under dual antiplatelet therapy (71%)., Conclusions: Very late DES failure often causes ST-elevation myocardial infarction; these very late events may not correlate with the interruption of antiplatelet therapy. Severe, late acquired ISA belongs to DES and is frequently observed in patients with very late DES thrombosis., (Copyright © 2013 Wiley Periodicals, Inc.)

A man with severe rheumatic trivalvular disease was treated with surgical implantation of mechanical aortic and mitral prostheses at the age of 30 years and tricuspid bioprosthesis at the age of 50 years. At 61 years of age, he developed severe symptomatic tricuspid regurgitation due to bioprosthesis degeneration and was judged at very high risk for a third surgical approach. The investigators describe the successful transfemoral positioning of a 29-mm Edwards SAPIEN XT percutaneous valve inside the degenerated tricuspid prosthesis, with excellent acute results and no major complications. In conclusion, percutaneous valve-in-valve treatment of degenerated bioprostheses is feasible by the transfemoral route and may be of assistance in very selected patients at high surgical risk., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Aims: To analyse the clinical outcome at 4 years in patients with coronary artery disease treated with bare metal stents (BMS) vs. BMS and oral prednisone, or drug-eluting stents (DES), all assuming similar adjunctive medical treatment., Methods and Results: Five Italian hospitals enrolled 375 non-diabetic, ischaemic patients without contraindications to dual anti-platelet treatment or corticosteroid therapy in a randomized controlled study. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischaemia needing repeated target vessel revascularization at 1 year, and this was significantly lower in the BMS group (80.8%) compared with the prednisone (88.0%) and DES group (88.8%, P = 0.04 and 0.006, respectively). The long-term analysis of the primary endpoint was a pre-specified aim of the trial, and was performed at 1447 days (median, IQ range = 1210-1641). Patients receiving BMS alone had significantly lower event-free survival (75.3%) compared with 84.1% in the prednisone group (HR: 0.447; 95% CI: 0.25-0.80, P = 0.007) and 80.6% in DES patients (HR: 0.519; 95% CI: 0.29-0.93, P = 0.03). Prednisone-treated patients did not develop new treatment-related clinical problems. Drug-eluting stents patients suffered more very late stent thrombosis as a cause of spontaneous myocardial infarction. The need for target vessel revascularization remained lower in the prednisone and DES groups (13.6 and 15.2%, respectively), compared with BMS (23.2%)., Conclusions: The clinical benefits of prednisone compared with BMS only persisted almost unchanged at 4 years. Drug-eluting stents performed better than BMS at long-term, although the advantages observed at 1 year were in part attenuated because of the occurrence of very late stent thrombosis and late revascularizations. Clinical Trial NCT 00369356.

Background: Contrast-induced nephropathy (CI-AKI) is a complication of diagnostic/therapeutic hemodynamic procedures in cardiology, which may also cause renal cholesterolinic atheroembolism. Despite the 
severe clinical impact of these complications, there is no optimal therapy for preventing and treating them. We suggest a short course of high-dose steroids as an effective preventive measure., Methods: Patients at risk of CI-AKI (n = 38) undergoing cardiovascular procedures were assigned 1:1 to 1 of 2 experimental arms (prednisone+hydration vs. hydration alone). Oral prednisone 1 mg/kg was administered 12 hours before, at 6 am on the same day, and 24 hours following the procedure. Serum creatinine was tested immediately before and again 24-48 hours after the procedure; neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), protein and albumin were assayed in spot urine before and 6 hours after the procedure.
, Results: NGAL and KIM-1 tended to rise after the procedure, but to a lesser degree in the prednisone group (delta NGAL: hydration = +128%, prednisone = +46%; 
p = 0.26; delta KIM-1: hydration = +99%, prednisone = +11%; p = 0.02). Proteinuria and albuminuria decreased significantly in the prednisone group. In 5 patients developing CI-AKI, their delta NGAL and delta KIM-1 did not differ from the values seen in patients without 
CI-AKI. Hypertension, peripheral arteriopathy and use of low-dose aspirin or diuretics were positive predictors of baseline NGAL, while treatment with calcium channel blockers and statins were negative predictors. Statins were negative predictors of baseline KIM-1., Conclusions: A short course of prednisone reduces the procedure-induced changes in biomarkers of renal tubular damage. This study suggests that steroids had a tubule-protecting effect.