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Background: Patients experiencing non-ST segment elevation acute-coronary-syndromes (NSTE-ACS) often present with multivessel-coronary-artery-disease (MVD). An immediate complete multivessel revascularization (MVR) - within the index hospitalization - may be considered the default therapeutic strategy, although its risk-to-benefit profile has not been definitively established through dedicated clinical trials., Methods: A systematic review and meta-analysis, adhering to MOOSE and PRISMA guidelines, was conducted to assess studies comparing immediate MVR versus a conservative culprit-only revascularization (COR) in NSTE-ACS with MVD. The main endpoints were all-cause death, major adverse cardiovascular events (MACE) and non-fatal myocardial infarction (MI). The incidence of any revascularization or further percutaneous-coronary-interventions (PCIs) were also collected. The primary analyses for the main endpoints were conducted on propensity-matched groups only., Results: A total of 22 studies (182,798 patients) were identified. 7 studies, encompassing 11,372 patients, were included in the primary analysis of propensity score-matched groups. Immediate MVR significantly increased (28%) survival (OR 0.72, 95% CI 0.58-0.90, P < 0.01) along with a 35% reduction in MACE (OR 0.65, 95% CI 0.47-0.88, P = 0.01) and a 60% decrease in MI (OR 0.40, 95% CI 0.25-0.63, P < 0.01) during a mean 3-years follow-up compared to the propensity score-matched COR group. Results were consistent in the unmatched analyses., Conclusions: This meta-analysis supports an immediate MVR for improving clinical outcomes in patients with NSTE-ACS and MVD as compared to a conservative immediate COR. These data prompt further evaluations regarding optimal strategies in the pursuit of MVR, including patient selection, revascularization modality, and assessment methods of revascularization completeness., Competing Interests: Declaration of competing interest Francesco Bianchini received a research grant from Abbott Vascular. Enrico Romagnoli received speaker fees from Abbott, Abiomed and Terumo.Cristina Aurigemma has been involved in advisory board activities by Abbott, Abiomed, Medtronic, and Biotronic. Lazzaro Paraggio received speaker fees from Abiomed and Terumo. Mattia Lunardi received speaker fees from Medtronic. Antonio Maria Leone received speakers' fees from Abbott Vascular, Medtronic, Menarini, Bayer, Daichii Sankyo, Bruno. Giuseppe Biondi-Zoccai has consulted for Amarin, Balmed, Cardionovum, Crannmedical, Endocore Lab, Eukon, Guidotti, Innovheart, Meditrial, Microport, Opsens Medical, Terumo, and Translumina, outside the present work. Carlo Trani and Francesco Burzotta received speaker fees from Abbott Vascular, Abiomed, Medtronic and Terumo. The other authors have no conflicts of interest to declare., (Copyright © 2024. Published by Elsevier B.V.)

Background: The possibility to resheath some transcatheter heart valves (THV) facilitates the optimization of self-expandable devices implantation. However, resheating manoeuvres (expecially when repeated) increase the interaction between the transcatheter prosthesis and the patient's tissues potentially causing side-effects., Aims: To assess the clinical outcomes of resheathing at midterm follow-up with a focus on the safety of multiple resheathing., Methods: This retrospective observational study included all consecutive patients who underwent TAVI with a self-expandable supra-annular THV between December 2018 and December 2022. Primary endpoint was a composite of cardiovascular (CV) mortality, neurological events, non-fatal acute myocardial infarction and CV rehospitalizations. All clinical endpoints were assessed according to VARC-3 criteria., Results: 469 TAVI procedures with self-expandable supra-annular THV were included in the study. The attempt to resheath and the resheath manoeuvres number was prospectively recorded into an electronic database. Resheating was attempted in 253 (53.9%) cases; 1, 2 and ≥ 3 resheathing were performed in respectively 122 (26.0%), 63 (13.4%) and 68 (14.5%) procedures. At a median follow-up of 640 days (interquartile range 340-1033 days), the incidence of the primary endpoint did not differ between 0 vs. ≥1 (22.7 vs. 26.1%, LogRank p = 0.584) and < 3 vs. ≥3 resheathing groups (24.2 vs. 26.5% LogRank p = 0.963). Furthermore, no significant differences in the primary endpoint were observed between 0, 1-2 and ≥ 3 resheathing (p = 0.84)., Conclusions: Our study found that resheathing of self-expandable THVs during TAVI did not result in worse clinical outcomes compared with no resheathing at mid-term follow-up. These results are independent from the number of resheathing, underling the safety of multiple resheathing in terms of peri-procedural and mid-term outcome., Condensed Abstract: In this retrospective observational study of 469 patients undergoing transcatheter aortic valve implantation (TAVI) for symptomatic severe aortic stenosis with self-expanding valves, we investigated the influence of resheathing on mid-term clinical outcomes. Specifically, we focused on the safety of multiple resheathing procedures. Our findings revealed no significant impact of resheathing on medium-term outcomes. The primary endpoint, a composite of cardiovascular mortality, neurological events, non-fatal acute myocardial infarction, and cardiovascular rehospitalizations, did not show statistically significant differences between no resheathing, single resheathing and multiple resheathing groups. Our study suggests that resheathing, even when performed multiple times, does not appear to significantly affect clinical outcomes at mid-term follow-up., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Routine thrombus aspiration (TA) does not improve clinical outcomes in patients with ST-segment-elevation myocardial infarction (STEMI), although data from meta-analyses suggest that patients with high thrombus burden may benefit from it. The impact of TA on left ventricular (LV) functional recovery and remodeling after STEMI remains controversial. We aimed to pool data from randomized controlled trials (RCTs) on the impact of TA on LV function and remodeling after primary percutaneous coronary intervention (pPCI)., Methods: PubMed and CENTRAL databases were scanned for eligible studies. Primary outcome measures were: LV ejection fraction (LVEF), LV end diastolic volume (LVEDV), LV end systolic volume (LVESV) and wall motion score index (WMSI). A primary pre-specified subgroup analysis was performed comparing manual TA with mechanical TA., Results: A total of 28 studies enrolling 4990 patients were included. WMSI was lower in TA group than in control (mean difference [MD] -0.11, 95% confidence interval [CI] -0.19 to -0.03). A greater LVEF (MD 1.91, 95% CI 0.76 to 3) and a smaller LVESV (MD -6.19, 95% CI -8.7 to -3.6) were observed in manual TA group compared to control. Meta regressions including patients with left anterior descending artery (LAD) involvement showed an association between TA use and the reduction of both LVEDV and LVESV (z = -2.13, p = 0.03; z = -3.7, p < 0.01) and the improvement in myocardial salvage index (z = 2.04, p = 0.04)., Conclusion: TA is associated with improved LV function. TA technique, total ischemic time and LAD involvement appears to influence TA benefit on post-infarction LV remodeling., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: Several implant-based remote monitoring strategies are currently tested to optimize heart failure (HF) management by anticipating clinical decompensation and preventing hospitalization. Among these solutions, the modern implantable cardioverter-defibrillator and cardiac resynchronization therapy devices have been equipped with sensors allowing continuous monitoring of multiple preclinical markers of worsening HF, including factors of autonomic adaptation, patient activity, and intrathoracic impedance., Objectives: We aimed to assess whether implant-based multiparameter remote monitoring strategy for guided HF management improves clinical outcomes when compared to standard clinical care., Methods: A systematic literature research for randomized controlled trials (RCTs) comparing multiparameter-guided HF management versus standard of care was performed on PubMed, Embase, and CENTRAL databases. Incidence rate ratios (IRRs) and associated 95% confidence intervals (CIs) were calculated using the Poisson regression model with random study effects. The primary outcome was a composite of all-cause death and HF hospitalization events, whereas secondary endpoints included the individual components of the primary outcome., Results: Our meta-analysis included 6 RCTs, amounting to a total of 4869 patients with an average follow-up time of 18 months. Compared with standard clinical management, the multiparameter-guided strategy reduced the risk of the primary composite outcome (IRR 0.83, 95%CI 0.71-0.99), driven by statistically significant effect on both HF hospitalization events (IRR 0.75, 95%CI 0.61-0.93) and all-cause death (IRR 0.80, 95%CI 0.66-0.96)., Conclusion: Implant-based multiparameter remote monitoring strategy for guided HF management is associated with significant benefit on clinical outcomes compared to standard clinical care, providing a benefit on both hospitalization events and all-cause death., Competing Interests: Declaration of Competing Interest The authors declare that they have no conflict of interest., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: The use of Impella support is increasingly adopted to "protect" patients with severe coronary artery disease (CAD) and left ventricle (LV) dysfunction undergoing percutaneous coronary intervention (PCI)., Aims: To evaluate the impact of Impella-protected (Abiomed, Danvers, Massachusetts, USA) PCIs on myocardial function recovery., Methods: Patients with significant LV dysfunction undergoing multi-vessel PCIs with pre-intervention Impella implantation were evaluated by echocardiography before PCI and at median follow up of 6 months: global and segmental LV contractile function were assessed by LV ejection fraction (LVEF) and wall motion score index (WMSI), respectively. Extent of revascularization was graded using the British Cardiovascular Intervention Society Jeopardy score (BCIS-JS). Study endpoints were LVEF and WMSI improvement, and its correlation with revascularization., Results: A total of 48 high surgical risk (mean EuroSCORE II 8) patients with median LVEF value of 30%, extensive wall motion abnormalities (median WMSI 2.16), and severe multi-vessel CAD (mean SYNTAX score 35) were included. PCIs brought a significant reduction of ischemic myocardium burden with BCIS-JS decrease from mean value of 12 to 4 (p < 0.001). At follow-up, WMSI reduced from 2.2 to 2.0 (p = 0.004) and LVEF increased from 30% to 35% (p = 0.016). WMSI improvement was proportional to the baseline impairment (R - 0.50, p < 0.001), and confined to revascularized segments (from 2.1 to 1.9, p < 0.001)., Conclusions: In patients with extensive CAD and severe LV dysfunction, multi-vessel Impella-protected PCI was associated to an appreciable contractile recovery, mainly determined by regional wall motion improvement in revascularized segments., Competing Interests: Declaration of Competing Interest Dr. Romagnoli, Dr. Burzotta, Dr. Aurigemma, and Dr. Trani has received speaker's fees by Medtronic, Abiomed, and St. Jude. The other authors disclose no conflicts of interest., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: The impact of myocardial revascularization on outcomes and prognosis in patients with chronic coronary syndrome (CCS) without left main (LM) disease or reduced left ventricle ejection fraction (LVEF) may be influenced by the revascularization strategy adopted., Methods: We performed a network meta-analysis including 18 randomized controlled trials comparing different revascularization strategies, including angiography-guided percutaneous coronary intervention (PCI), physiology-guided PCI and coronary artery bypass graft (CABG), in patients with CCS without LM disease or reduced LVEF., Results: Compared with medical therapy, all revascularization strategies were associated with a reduction of the primary endpoint, as defined in each trial, the extent of which was modest with angiography-guided PCI (IRR 0.86, 95% CI 0.75-0.99) and greater with physiology-guided PCI (IRR 0.60, 95% CI 0.47-0.77) and CABG (IRR 0.58, 95% CI 0.48-0.70). Moreover, angiography-guided PCI was associated with an increase of the primary endpoint compared to physiology-guided PCI (IRR 1.43, 95% CI 1.14-1.79) and CABG (IRR 1.49, 95% CI 1.27-1.74). CABG was the only strategy associated with reduced myocardial infarction (IRR 0.68, 95% CI 0.52-0.90), cardiovascular death (IRR 0.76, 95% CI 0.64-0.89), and all-cause death (IRR 0.87, 95% CI 0.77-0.99), but increased stroke (IRR 1.69, 95% CI 1.04-2.76)., Conclusions: In CCS patients without LM disease or reduced LVEF, physiology-guided PCI and CABG are associated with better outcomes than angiography-guided PCI. Compared with medical therapy, CABG is the only revascularization strategy associated with a reduction of myocardial infarction and death rates, at the cost of higher risk of stroke., Study Registration: This study is registered in PROSPERO (CRD42022313612)., Competing Interests: Declaration of Competing Interest M.G. declares that he has received consulting fees or honoraria from Terumo, outside the present work. D.C. declares that he has received consulting and speaker's fee from Amgen, Daiichi Sankyo, Sanofi, Tarumo outside the present work. G.B.-Z. has consulted for Cardionovum, CrannMed, InnovHeart, Meditrial, Opsens Medical, Replycare and Terumo, outside the present work. I.P. reports consultant or speaker fees from Biotronik, ABIOMED, Terumo, Philips, Sanofi, Amgen, Daiichi-Sankyo, Astra Zeneca, Bayer, and PIAM, outside the present work. F.B. declares that he has received consulting fees or honoraria from Abbott, Abiomed, Medtronic and Terumo, outside the present work. C.T. declares that he has received consulting fees or honoraria from Abbott, Abiomed, Medtronic and Terumo, outside the present work. R.DC. declares that he has received consulting fees or honoraria from Daiichi-Sankyo, Novartis, Roche, Boehringer Ingelheim, Bayer, BMS/Pfizer, Janssen, Novartis, AspraZeneca, Milestone, Lilly, Menarini, Guidotti, outside the present work. J.E. declares that he has participated as speaker at educational events and advisory board member for Abbott, Boston Scientific and Philips. D.J.A. declares that he has received consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, and Sanofi, outside the present work. D.J.A. also declares that his institution has received research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, Renal Guard Solutions and Scott R. MacKenzie Foundation. F.C. declares that he has received consulting and speaker's fee from Amgen, AstraZeneca, Servier, BMS, outside the present work. F.C. also declares to be member of the advisory board of GlyCardial Diagnostics. The remaining authors report no disclosures., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Aims: Wall shear stress (WSS) is involved in coronary artery plaque pathological mechanisms and modulation of gene expression. This study aims to provide a comprehensive haemodynamic and biological description of unstable (intact-fibrous-cap, IFC, and ruptured-fibrous-cap, RFC) and stable (chronic coronary syndrome, CCS) plaques and investigate any correlation between WSS and molecular pathways., Methods and Results: We enrolled 24 CCS and 25 Non-ST Elevation Myocardial Infarction-ACS patients with IFC (n = 11) and RFC (n = 14) culprit lesions according to optical coherence tomography analysis. A real-time PCR primer array was performed on peripheral blood mononuclear cells for 17 different molecules whose expression is linked to WSS. Computational fluid dynamics simulations were performed in high-fidelity 3D-coronary artery anatomical models for three patients per group. A total of nine genes were significantly overexpressed in the unstable patients as compared to CCS patients, with no differences between IFC and RFC groups (GPX1, MMP1, MMP9, NOS3, PLA2G7, PI16, SOD1, TIMP1, and TFRC) while four displayed different levels between IFC and RFC groups (TNFα, ADAMTS13, EDN1, and LGALS8). A significantly higher WSS was observed in the RFC group (p < 0.001) compared to the two other groups. A significant correlation was observed between TNFα (p < 0.001), EDN1 (p = 0.036), and MMP9 (p = 0.005) and WSS values in the RFC group., Conclusions: Our data demonstrate that IFC and RFC plaques are subject to different WSS conditions and gene expressions, suggesting that WSS profiling may play an essential role in the plaque instability characterization with relevant diagnostic and therapeutic implications in the era of precision medicine., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Several studies have compared surface electrocardiographic changes following different self-expandable (SE) (Evolut (Medtronic, USA); Acurate (Boston Scientific, USA); Portico (Abbott, USA); and Allegra (NVT, Germany)) and balloon-expandable (BE) Sapien-3 (Edwards Lifesciences, USA) transcatheter heart valves. We aimed to compare these prosthesis with the novel Myval BE prosthesis (Meril Life, India)., Methods: Academic European registry of consecutive patients with severe aortic stenosis who received any of the 6 aforementioned valves. Baseline, post-procedural, and discharge 12‑leads electrocardiograms (ECG) were centrally analyzed and compared., Results: A total of 1131 patients were included: 135 Myval (11.9%), 290 Sapien-3 (25.6%), 298 Evolut (26.3%), 180 Acurate (15.9%), 125 Portico (11.1%), and 103 Allegra (9.1%). There were no baseline differences in intraventricular conduction disturbances rate. Compared to the novel BE Myval, there were similar procedural and in-hospital outcomes. Similar rates of early new permanent pacemaker implant (PPI) were observed amongst Myval (7.4%), Sapien-3 (13.4%), and Acurate (9.1%), but Evolut, Portico, and Allegra presented significantly higher rates (18.5%, p = 0.003; 29.5% p < 0.001 and 22%, p = 0.001, respectively). Central analysis of ECGs, unraveled significant prolongation of the PR segment with Evolut, Portico and Allegra whereas Evolut, Acurate, and Portico showed significant QRS widening compared to Myval. However, at discharge no differences in PR segment duration were observed while, Evolut, and Portico- but not Acurate, Allegra or Sapien-3 - still presented significant widening of QRS segment compared to Myval., Conclusions: After blinded central ECG analysis, the novel Myval balloon-expandable prosthesis was associated with a low rate of early conduction disturbances., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Coronavirus disease 2019 (COVID-19) has caused an unprecedented change in the apparent epidemiology of acute coronary syndromes (ACS). However, the interplay between this disease, changes in pollution, climate, and aversion to activation of emergency medical services represents a challenging conundrum. We aimed at appraising the impact of COVID-19, weather, and environment features on the occurrence of ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) in a large Italian region and metropolitan area., Methods and Results: Italy was hit early on by COVID-19, such that state of emergency was declared on January 31, 2020, and national lockdown implemented on March 9, 2020, mainly because the accrual of cases in Northern Italy. In order to appraise the independent contribution on changes in STEMI and NSTEMI daily rates of COVID-19, climate and pollution, we collected data on these clinical events from tertiary care cardiovascular centers in the Lazio region and Rome metropolitan area. Multilevel Poisson modeling was used to appraise unadjusted and adjusted effect estimates for the daily incidence of STEMI and NSTEMI cases. The sample included 1448 STEMI and 2040 NSTEMI, with a total of 2882 PCI spanning 6 months. Significant reductions in STEMI and NSTEMI were evident already in early February 2020 (all p<0.05), concomitantly with COVID-19 spread and institution of national countermeasures. Changes in STEMI and NSTEMI were inversely associated with daily COVID-19 tests, cases, and/or death (p<0.05). In addition, STEMI and NSTEMI incidences were associated with daily NO2, PM10, and O3 concentrations, as well as temperature (p<0.05). Multi-stage and multiply adjusted models highlighted that reductions in STEMI were significantly associated with COVID-19 data (p<0.001), whereas changes in NSTEMI were significantly associated with both NO2 and COVID-19 data (both p<0.001)., Conclusions: Reductions in STEMI and NSTEMI in the COVID-19 pandemic may depend on different concomitant epidemiologic and pathophysiologic mechanisms. In particular, recent changes in STEMI may depend on COVID-19 scare, leading to excess all-cause mortality, or effective reduced incidence, whereas reductions in NSTEMI may also be due to beneficial reductions in NO2 emissions in the lockdown phase., Competing Interests: Declaration of Competing Interest Prof. Biondi-Zoccai has consulted for Cardionovum, Bonn, Germany, InnovHeart, Milan, Italy, Meditrial, Rome, Italy, and Replycare, Rome, Italy., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Contrast fractional flow reserve (cFFR) is a relatively new tool for the assessment of intermediate coronary artery stenosis and represents a reliable surrogate of FFR with the advantage of potentially simplifying functional evaluation. We aimed to compare the incidence of major adverse cardiac events (MACE) in patients undergoing functional evaluation with both FFR and cFFR based on the results of the two indexes., Method and Result: We retrospectively analyzed outcomes in 488 patients who underwent functional evaluation with FFR and cFFR. Patients were divided into four groups using the cutoff values of 0.80 for FFR and 0.85 for cFFR: -/- (n = 298), +/+ (n = 134), -/+(n = 31) and +/- (n = 25). All patients were treated according to FFR value. MACE rate was assessed in each group, including death, myocardial infarction and urgent target vessel revascularization (TVR). Mean follow-up time was 22 ± 15 months. Incidence of MACE at follow-up was 8.3% in FFR-/cFFR-, 14.0% in FFR+/cFFR+, 16.0% in FFR-/cFFR+ and 8.0% in FFR+/cFFR- without a significant difference amongst the 4 groups (p = 0.2). Nevertheless, a significant difference in the rate of TVR comparing FFR-/cFFR- (n = 17) and FFR-/cFFR+ (n = 5) was found at 24 months (5.7% vs 16.0%; p = 0.027)., Conclusion: cFFR is accurate in predicting FFR and consequently reliable in guiding coronary revascularization. In the rare case of discordance, while FFR+/cFFR- patients show a prognosis similar to FFR-/cFFR- patients, FFR-/cFFR+ patients show a prognosis similar to FFR+/cFFR+ patients., Competing Interests: Declaration of Competing Interest A.M.L. received speaking honoraria from St. Jude Medical/Abbott, Medtronic, Abiomed and from Bracco Imaging, C.T, F.B. received speaker's fees from Abbott, Medtronic, and Abiomed. The other authors have no conflicts of interest., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Adenosine-free indexes (AFIs), including resting Pd/Pa, instantaneous wave-free ratio (iFR) and contrast-FFR (cFFR), have been proposed to circumvent the use of vasodilators, in order to simplify the functional evaluation of coronary stenoses. Aims of this study were to analyze the correlation between AFIs and Fractional Flow Reserve (FFR) and to compare their diagnostic accuracy when FFR is used as reference., Methods: We conducted a systematic review and meta-analysis of observational studies in which AFIs were compared to FFR. We produced paired forest plots to show the variation of the sensitivity and specificity estimates. We used a hierarchical summary ROC model (HSROC) to summarize the sensitivity and specificity of AFIs in detecting the concordance with FFR assessment., Results: Eighteen studies were included in this meta-analysis. Overall, 4424, 4822 and 2021 coronary lesions in 4410, 4472 and 1898 patients, respectively, were evaluated by Pd/Pa, iFR and cFFR, respectively. The overall Pearson's correlations were 0.81 (95%CI 0.78-0.83), 0.80 (95%CI 0.78-0.81) and 0.92 (95%CI 0.90-0.94) for Pd/Pa, iFR and cFFR, respectively. cFFR showed a significantly higher correlation with FFR compared to Pd/Pa and iFR (p < 0.0001). The area under the HSROC estimating the discriminating accuracy of cFFR was 0.95 (95%CI 0.94-0.96) and it was significantly higher compared to Pd/Pa (0.86, 95%CI 0.80-0.93) and iFR (0.89, 95%CI 0.84-0.94) (p < 0.0001)., Conclusions: AFIs show a good correlation with the gold standard FFR. Among AFIs, cFFR shows the highest correlation with FFR and the best diagnostic accuracy., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Percutaneous coronary intervention (PCI) is establishing as the last remaining revascularization option in an increasing number of patients affected by complex coronary artery disease not suitable for surgery. Over the past decade, percutaneous left ventricular assist device (pLVAD) has increasingly replaced intra-aortic balloon pump to provide hemodynamic support during such non-emergent complex high-risk indicated procedures (CHIP) averting the risk of circulatory collapse and of adverse events in long lasting and/or complicated procedures. This review article aims to report the key factors to define CHIP, to summarize the available pLVAD which have CE mark for temporary mechanical LV support and to discuss the rationale of their use in this subset of patients. Based on the expertise of the Italian Society of Interventional Cardiology working group, with the endorsement from Spanish and Portuguese Society of Interventional Cardiology working groups, it will provide several practical suggestions in regards to the use of pLVAD in different clinical CHIP scenarios., (Copyright © 2019. Published by Elsevier B.V.)

Background: Dual quantitative coronary angiography (QCA) has been recently tested for assessment of intracoronary thrombus volume in experimental models. The present study aimed to validate dual QCA in vivo for the assessment of thrombus burden by exploring the correlations between dual QCA-thrombus volume and optical coherence tomography (OCT)-derived indices of thrombotic burden., Methods and Results: Fifty-one patients with ACS and angiographic evidence of thrombus undergoing OCT of the culprit lesion before stenting were included. Dual QCA-thrombus volume was calculated as difference between edge-detection and video-densitometry area functions along the target segment. Culprit lesion was categorized using the Ambrose's and AHA/ACC angiographic classifications. Thrombus volume (mean thrombus area × thrombus length), thrombus burden [(mean thrombus area/mean lumen area) x100] and Prati thrombus score (number of quadrants with thrombus) were measured by OCT, and the presence of plaque rupture (PR) or intact fibrous cap (IFC) was assessed. Dual QCA-thrombus volume correlated significantly with OCT-thrombus volume (R = 0.791), thrombus burden (R = 0.767) and Prati thrombus score (R = 0.600) (all p < 0.001). Dual-QCA thrombus volume was significantly higher in patients with PR compared with those with IFC (3.48 mm 3 [1.45-11.26] vs. 1.69 mm 3 [0.09-5.02], p = 0.013). Compared with IFC, PR showed higher prevalence of eccentric type II Ambrose lesion (41.7% vs. 7.4%, p = 0.004), complex B2/C lesion (87.5% vs. 55.6%, p = 0.012), and heavy calcification (29.2% vs. 3.7%, p = 0.013)., Conclusions: Dual QCA analysis appears to be a promising tool for quantification of intracoronary thrombus in vivo. This novel methodology may be useful to guide intracoronary thrombus removal during percutaneous coronary intervention and to aid prognostic stratification in patients with ACS., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Fractional Flow Reserve (FFR) in Stable Ischemic Heart Disease (SIHD) is universally accepted, while in Acute Coronary Syndromes (ACS) is less established. Aims of this retrospective study were: to compare in patients undergoing FFR assessment the prognostic impact of ACS vs SIHD, to evaluate the clinical relevance of the modality of utilization and timing of FFR assessment and to assess the different outcomes associated with an FFR> or ≤0.80., Methods: Major cardiac adverse events were assessed at a follow up of 16.4 ± 10.5 months in 543 patients with SIHD and 231 with ACS needing functional evaluation. FFR was used for lesions of ambiguous significance in the absence of a clear culprit vessel (first intention, FI) and for incidental lesions in the presence of a clear culprit vessel (second intention, SI). The decision to perform FFR and the identification of the stenosis needing functional assessment were left to the operator's discretion. Revascularization was performed when FFR was ≤0.80., Results: SIHD and ACS patients were not significantly different for principal clinical characteristics. ACS patients had significantly more events than SIHD, due to an excess of death and myocardial infarction. This was confirmed when FFR was used as FI, in particular if FFR was >0.80. On the contrary, when FFR was used as SI, event rates were similar between ACS and SIHD patients, regardless of FFR value., Conclusions: Our study shows that using FFR the risk of recurrent events in ACS is significantly higher than in SIHD. This different outcome is confined to those patients in whom FFR is utilized for lesions of ambiguous significance in the absence of a clear culprit vessel., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: A sizeable proportion of patients with Acute Coronary Syndromes (ACS) shows a unique adaptive immune system profile, associated to a worse outcome, characterized by higher CD4 + CD28 null T-cells, lower regulatory T-cells (Treg) and increased CD4 + CD28 null /Treg ratio. We sought to investigate the correlation between CD4 + CD28 null T-cells, Treg, CD4 + CD28 null /Treg ratio and plaque phenotype as assessed by Optical Coherence Tomography (OCT)., Methods: Peripheral blood mononuclear cells (PBMC) were collected from 30 Non-ST Elevation Myocardial Infarction (NSTEMI) patients, sub-grouped according to OCT analysis of culprit lesions into two cohorts: Ruptured Fibrous Cap (NSTEMI-RFC, n = 12) and Intact Fibrous Cap (NSTEMI-IFC, n = 18). Stable Angina patients (SA, n = 18) were used as controls. We examined the frequency of CD4 + CD28 null and Treg (defined as CD4 + CD25 high CD127 low Foxp3 + T-cells) by flow-cytometry., Results: CD4 + CD28 null frequency (median, range) was significantly higher in NSTEMI-RFC patients (17.3%, 12.5-33.8) as compared with NSTEMI-IFC (3.8%, 0.3-14.1) and SA (3%, 0.6-17.7) (P < 0.001 for all comparisons). We also found a higher CD4 + CD28 null /Treg ratio in NSTEMI-RFC patients (6.6%, 3.7-13.9) than in NSTEMI-IFC (1.6%, 0.3-5.2) and SA (1.2%, 0.3-8.7) (P < 0.001 for all comparisons). Finally, there was an inverse correlation between CD4 + CD28 null /Treg ratio and cap-thickness (R = -0.44; P = 0.002)., Conclusion: Patients with NSTEMI presenting with RFC as culprit lesion at OCT evaluation have a specific perturbation of adaptive immunity, mostly involving CD4 + CD28 null T- cells and Tregs, as compared with patients with IFC and SA. This specific imbalance of T-cells might play a key role in fibrous cap thinning, predisposing atherosclerotic plaque to rupture., (Copyright © 2018 Elsevier B.V. All rights reserved.)

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.)

Background: The decision-making process of patients with angiographically-intermediate coronary lesions (ICL) is clinically challenging and may benefit from adjunctive invasive techniques. Fractional-flow-reserve (FFR) represents the gold standard to evaluate ICL but frequency-domain optical-coherence-tomography (OCT) is a novel, promising, high resolution coronary imaging technique, which allows physiopathologic assessment of coronary plaque. We investigated the possible relation between OCT and FFR in selected ICL patients., Methods: Stable or unstable patients with ICL who underwent both FFR and OCT assessment at two large tertiary centers were retrospectively enrolled. FFR was performed according to standard methodology. OCT images were (on blind to clinical and FFR results) analyzed to assess minimal lumen area (MLA), percentage area stenosis (AS), thrombus and plaque ulceration., Results: Forty patients were identified (62±10years, 93% symptomatic, 35% acute presentation, 93% left-anterior-descending artery ICL). Percentage diameter stenosis at quantitative coronary angiography was 40±12% and FFR was 0.85±0.07. MLA (p=0.009), AS (p<0.001) and plaque ulceration (p=0.02) were significantly associated with FFR values. An integrated assessment of AS (≥ or <70%), MLA (≥ or <2.5mm 2 ) and presence or absence of thrombus and plaque ulceration was found to have the potential to accurately (sensitivity 91%, specificity 93%) predict FFR results., Conclusion: In patients with ICL, a combination of different OCT parameters may help predict FFR results. These findings suggest that only a comprehensive assessment of lesion features by OCT can allow an accurate prediction of lesion severity assessed by FFR., (Copyright © 2017. Published by Elsevier B.V.)

Background: Left main (LM) atherosclerotic lesions affect clinical outcomes. Frequency domain-optical coherence tomography (FD-OCT) allows detailed characterization of non-ostial coronary atherosclerotic lesions. The clinical impact of FD-OCT assessment of LM bifurcation disease on the revascularization decision is unknown., Methods: Patients who underwent FD-OCT assessment to guide management of angiographically intermediate distal LM stenosis were retrospectively selected. The FD-OCT LM criteria for percutaneous or surgical revascularization were: Clinical follow-up was obtained to evaluate the occurrence of target vessel failure (TVF) defined as cardiac death and/or acute myocardial infarction (AMI) not related to other vessel and/or target vessel revascularization., Results: Out of 131 patients underwent FD-OCT assessment of LM, 122 patients (93%) entered the study. Based on FD-OCT features, 58 (48%) patients were conservatively managed, while the remaining 64 (52%) were revascularized by stenting (n=48) or surgery (n=16). After a mean follow-up of 18months, TVF-free survival was not different between patients undergoing conservative management vs. revascularization (HR 0.40, CI 95% 0.10-1.61, P=0.20). Of note, two patients only in the conservative management group had TVF (elective LM stenting, no death or myocardial infarction)., Conclusions: This preliminary experience suggests that a FD-OCT based management for patients with angiographically-intermediate LM bifurcation stenosis may help identify patients in whom revascularization could be deferred. Such observation calls for further evaluations by appropriately designed trials., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching., Methods: Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n=1846) or Evolut R (n=302) were prospectively included in the Italian TAVI ClinicalService® project. For the purpose of our analysis 211 patients treated with the Evolut R were matched to 211 patients treated with the CoreValve. An independent core laboratory reviewed all angiographic procedural data and an independent clinical events committee adjudicated all events., Results: Patients treated with Evolut R experienced higher 1-year overall survival (log rank test p=0.045) and a significantly lower incidence of major vascular access complications, bleeding events and acute kidney injury compared to patients treated with the CoreValve. Recapture manoeuvres to optimize valve deployment were performed 44 times, allowing a less implantation depth for the Evolut R. As a consequence, the rate of more than mild paravalvular leak and new permanent pacemaker was lower in patients receiving the Evolut R., Conclusion: In this matched comparison of high surgical risk patients undergoing TAVI, the use of Evolut R was associated with a significant survival benefit at 1year compared with the CoreValve. This was driven by lower incidence of periprocedural complications and higher rates of correct anatomic positioning., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Aims: Microvascular obstruction (MVO) is associated with a worse prognosis in patients with ST-elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI). However, data about incidence, clinical outcome and correlates of MVO in latecomers after STEMI are still lacking., Methods: We prospectively enrolled consecutive patients that were latecomers after STEMI (symptoms onset >12h) undergoing PCI. We performed an angiographic analysis to assess the occurrence of MVO [defined as TIMI flow grade ≤2 or 3 with a myocardial blush grade <2]. Moreover, we performed a clinical and echocardiographic follow-up to assess the occurrence of major adverse cardiovascular events (MACE), defined as the composite of cardiac death, myocardial infarction and rehospitalization for heart failure, and to evaluate left ventricle remodelling., Results: Seventy-eight patients were enrolled [mean age 67.58±11.72years, 57 (73%) male; mean time of symptom onset 23.14±16.06h] with a mean follow-up time of 29.7±14.1months. MVO occurred in 39 (50%) patients. Patients with MVO had a higher rate of MACE [18 (46%) vs. 3 (8%), p<0.001] and LV remodelling [25 (64%) vs. 6 (15%), p<0.001] compared with patients without MVO. By multivariable Cox regression MVO and left anterior descending artery were independent predictors of MACE., Conclusions: Latecomers after STEMI have a high risk to develop MVO that is related to an adverse prognosis. Appropriate management and follow-up strategies should be implemented in such high-risk patients group., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Consistent evidence of benefit exists for radial access (RA) in ST-elevation acute myocardial infarction (STEMI). Patients with non ST-elevation acute coronary syndrome (NSTE-ACS) have a more varied ischemic and bleeding profile. No randomized trial of vascular access ever focused on NSTE-ACS and landmark studies did not provide conclusive results in this heterogeneous subset of patients., Methods: We assessed in a meta-analysis whether RA is associated with improved outcomes in NSTE-ACS patients. Included studies had to meet the following criteria: 1) enrolling patients with NSTE-ACS undergoing invasive management; 2) reporting outcomes with respect to RA as compared with femoral access (FA); 3) reporting short-term (procedural, in-hospital and up to 30-day) or long-term clinical outcomes. Studies were pooled with fixed and random effects models and heterogeneity was investigated by weighted meta-regression., Results: Eleven studies were included encompassing 131.339 patients, 46.451 receiving RA and 84.888 receiving FA. Thirty-day mortality and MACE were lower with RA (p<0.001 with fixed effects, p=NS with random effects model), but these results depended on one large observational database. Major bleeding was consistently reduced by RA (p<0.001), albeit an inverse relationship with the proportion of patients in each study receiving FA and experiencing major bleeding was evident. The association of RA with reduced long-term mortality was of borderline significance (p=0.054 with random-effects, p=0.001 with fixed-effect model) and also depended on major bleeding in FA patients., Conclusions: RA is associated with better outcomes as compared with FA in NSTE-ACS, although this observation is influenced by nonrandomized comparisons. Large heterogeneity exists among studies., Registration: This study is registered in the PROSPERO database (CRD42015029459)., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Diffuse coronary artery disease treatment still remains a challenge for interventional cardiologists and cardiac surgeons. There are few data on full metal jacket (FMJ) stenting, especially with new-generation drug-eluting stents. We aimed to assess the efficacy and safety of FMJ with new-generation Zotarolimus-eluting stents (n-ZES)., Methods and Results: All patients who underwent FMJ with n-ZES (≥60mm stent length) in eleven Italian interventional centers participating in the Clinical Service® project were included in this analysis. The project population consisted of 120 patients and 122 lesions. Mean age was 67±10years and 95 (79.2%) patients were male. A chronic total occlusion was present in 34 lesions (27.9%). The number of stents implanted per lesion was 2.9±0.8, and the diameter of the stents was 3.0±0.5mm. Predilation and post-dilatation were performed in 107 (87.7%) and 92 (75.4%) patients, respectively. At 41±21month follow-up there were 2 patients with subacute definite stent thrombosis, 6 patients (5.0%) had cardiac death and 5 patients (4.2%) had non-fatal myocardial infarction. Seven patients (5.8%) underwent clinically-driven target lesion revascularization. Fourteen patients (11.7%) had at least one major adverse cardiac event., Conclusion: The treatment of diffuse coronary artery disease with FMJ stenting with n-ZES appears to be effective and safe. Late and very-late ST does not seem to be an issue and the rate of restenosis and of major cardiac adverse events after more than 3-year follow-up is rather low., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Mechanical circulatory support represents an evolving field of clinical research and practice. Currently, several cardiac assist devices have been developed but, among different institutions and countries, a large variation in indications for use and device selection exists. The Impella platform is an easy to use percutaneous circulatory support device which is increasingly used worldwide. During 2014, we established a working group of European physicians who have collected considerable experience with the Impella device in recent years. By critically comparing the individual experiences and the operative protocols, this working group attempted to establish the best clinical practice with the technology. The present paper reviews the main theoretical principles of Impella and provides an up-to-date summary of the best practical aspects of device use which may help others gain the maximal advantage with Impella technology in a variety of clinical settings., (Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

Background: Percutaneous angioplasty of lower limb disease is commonly performed with a transfemoral access. In the coronary field, a transradial approach has shown to reduce access-site bleeding and adverse clinical events. This route has not yet been well studied for the majority of peripheral interventions, like those involving the iliac arteries. In this study we sought to evaluate the feasibility and safety of this approach for iliac interventions., Methods: Multicenter study was performed at high-volume centers with experience in transradial percutaneous interventions. Primary endpoint of the study was procedural success; secondary endpoints included in-hospital bleeding, 1-month freedom from adverse events and the rate of radial occlusion. Feasibility of this technique was evaluated by recording procedural and fluoroscopy time and contrast load., Results: A total of 149 patients from 5 centers were enrolled. The population had a medium risk profile, with 48% of patients having TASC 2 or 3 lesions. Procedural success was achieved in 98.7% of the population, and we did not register in-hospital complications, including both vascular access site and procedural-related complications. An ancillary transfemoral approach was used in 13% of patients. One-month freedom from symptoms was achieved in 97.3% of patients, and the rate of radial occlusion was 2.7%. Major determinants of an unsuccessful procedure were the use of normal 6 or 7-Fr introducer with guiding catheter, TASC D lesion attempt, lesion length>30 mm and total occlusion., Conclusions: A transradial approach for iliac disease may be a feasible and safe alternative to the transfemoral route in experienced hands, in the light of significant technical improvements and dedicated devices., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Objectives: To angiographically assess myocardial perfusion in patients with Tako-Tsubo syndrome (TTS) in comparison with control individuals and patients with ST-elevation myocardial infarction (STEMI)., Background: Coronary microvascular dysfunction has been proposed as the pathophysiological mechanism underlying TTS., Methods: We retrospectively selected consecutive TTS patients showing typical left ventricular (LV) apical dysfunction admitted to our Department in the period 2007-2011 (n=25). We also enrolled an age and gender-matched control group showing normal coronary arteries (CTR, n=25), patients with STEMI undergoing primary percutaneous intervention with myocardial reperfusion (SR, n=25) or microvascular obstruction (SMVO, n=25). TIMI flow, TIMI frame count (TFC) and both qualitative and quantitative myocardial blush grade in LV apex were assessed. Specifically, myocardial perfusion was quantitatively evaluated using 'Quantitative Blush Evaluator' (QuBE), an open source software previously validated in the setting of STEMI., Results: In TTS, TIMI flow on the LAD was significantly lower and TFC significantly higher compared to CTR and SR (p=0.008 for both), while it did not significantly differ compared to SMVO (p=0.06). In TTS, MBG was significantly lower than that in CTR and SR (p=0.001 for both), while it was significantly higher than that in SMVO (p<0.001). In TTS, QuBE score was significantly lower than that in CTR and SR (p=0.001 for both) and higher than in SMVO (p=0.02)., Conclusions: Our data indicate that myocardial perfusion assessed during angiography is more impaired in patients with TTS than in patients with STEMI exhibiting myocardial reperfusion, while it is less impaired than in patients with STEMI exhibiting MVO., (© 2013.)

Background: Access-site vascular complications (ASVC) in patients undergoing trans-radial coronary procedures are rare but may have relevant clinical consequences. Data regarding the optimal management of radial-access-related ASVC are lacking., Methods: During a period of 6 years we prospectively collected ASVC. ASVC were defined as any complication requiring ultrasound examination or upper limb angiography. ASVC were categorized according to the timing of diagnosis: "very early" (in the cath lab), "early" (after cath lab discharge, but during the hospital stay) and "late" (after hospital discharge). The need of surgery (primary end-point) and the development of neurological hand deficit (secondary end-point) were assessed., Results: Fifty-seven radial-artery related ASVC were collected. ASVC diagnosis was obtained by upper limb angiography in 25 patients (44%) and by Doppler in 32 patients (56%). Surgery was required in 6 cases (11%), the remaining patients receiving successful conservative management (which included prolonged local compression). Three patients (who received surgery) exhibited a mild neurological hand deficit in the follow-up. Need for surgery differed significantly according to timing of diagnosis as it occurred in 1 of 26 patients (3.8%) with "very early" diagnosis, in 1 of 21 patients (4.8%) with "early" diagnosis, and in 4 of 10 patients (40%) with "late" diagnosis (p=0.026)., Conclusions: ASVC are diagnosed with different timing after trans-radial procedures. Conservative management including local compression allows successful management in the majority of ASVC. Prompt recognition is pivotal as late diagnosis is associated to the need for surgery., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Background: The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a simple risk model able to predict early and late mortality after cardiac surgery. Recent data suggest that this score may also predict early clinical outcome after percutaneous coronary intervention (PCI). Data regarding EuroSCORE usefulness to predict late outcome after PCI in unselected patients are lacking., Methods: EuroSCORE was prospectively assessed in consecutive patients undergoing PCI during 18 months. The primary end-point was cardiac mortality during the follow-up after PCI. Total mortality was the secondary end-point. Kaplan-Meyer analyses were performed dividing the study population in three subgroups according to the additive EuroSCORE algorithm (low risk group: EuroSCORE 0-2; medium risk group: EuroSCORE 3-5; high-risk group: EuroSCORE ≥ 6). Receiver operating characteristics (ROC) curve and landmark analysis on cardiac mortality after 30 days were performed., Results: The study population comprised 1170 patients undergoing PCI. Mean follow-up duration was 633 days (range: 365-1000 days). Cardiac mortality was 2%; 2.4%; 13.2% in patients with low, medium and high EuroSCORE respectively. Kaplan-Meyer survival curves for cardiac death differed significantly between EuroSCORE groups (p<0.0001). The area under the ROC curve for the prediction of cardiac death was 0.77. Similar results were obtained for total mortality. At landmark analysis starting 30 days after PCI, EuroSCORE groups were significantly associated with different survival in the long term (P=0.014)., Conclusion: EuroSCORE risk model can be efficiently utilized to predict late mortality in consecutive, unselected, patients undergoing PCI., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Objectives: To investigate a possible independent predictive role of systemic inflammation markers on renal function after renal artery stenting., Background: An elevated baseline serum creatinine has previously been shown to be the strongest predictor of improved renal function after percutaneous renal artery stenting. The inflammatory system is implicated in every stage of chronic kidney disease, and we hypothesized an additional value of markers of systemic inflammation in predicting response after renal artery stenting., Methods: This single center, prospective study includes 62 consecutive patients with chronic kidney disease at stage ≥ 3 or resistant hypertension who underwent stent placement for 74 angiographically significant atherosclerotic renal lesions. Inflammatory markers, including serum C-reactive protein (CRP), erythrocyte sedimentation rate, and white blood cell count were determined prior to renal angioplasty and related to changes in renal function at follow-up., Results: Six-month clinical follow up was completed in 57 patients. Overall, median serum creatinine concentration exhibited a non significant reduction from 1.40 mg/dl (quartiles: 1.20, 1.75 mg/dl) at baseline to 1.30 mg/dl (quartiles: 1.1, 1.55 mg/dl) at 6 months (p=0.17). Significant multivariate independent predictors of decreased creatinine included higher baseline serum creatinine levels (adjusted OR per quartile increment, 2.5 [1.3 to 4.7], p=0.004) and lower C-reactive protein levels (adjusted OR per quartile increment 0.39 [0.19 to 0.82], p=0.013)., Conclusions: Patients with higher serum creatinine and lower CRP derive the most benefit from renal artery stenting., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Background: In the treatment of coronary bifurcation lesions (CBL), with drug eluting stents (DES), we sought to compare angiographic and clinical outcomes of a simple strategy of stenting main vessel only with balloon dilatation of the side branch with a complex strategy of stenting both branches., Methods: We performed a meta-analysis of six studies, randomized (three) or prospective observational (three), including 963 patients, that directly compared the simple strategy to the complex strategy, in the treatment of CBL with DES., Results: Final minimal lumen diameter (MLD) of the side branch was significantly smaller in the simple strategy group [WMD -0.50 mm, 95% CI (-0.76, -0.24), p<0.00001]. The risk of main vessel restenosis [RR 0.66, 95% CI (0.38-1.17), p=0.16], side branch restenosis [RR 0.62, 95% CI (0.24-1.56), p=0.31], follow up death [RR 0.60, 95% CI (0.19-1.86), p=0.38], follow up myocardial infarction [RR 0.71, 95% CI (0.46-1.10), p=0.13], or target vessel revascularization [RR 0.90, 95% CI (0.56-1.46), p=0.67] was similar between the two strategies. The simple strategy showed a trend to a lower risk of early myocardial infarction [RR 0.65, 95% CI (0.41-1.05), p=0.08]., Conclusion: In the treatment of unselected CBL with DES, the complex strategy does not penalize angiographic and clinical outcomes compared to the simple strategy. Further randomized studies are needed to assess the benefit of simple or complex strategy in the treatment of specific subsets of bifurcated lesions., (Copyright 2008 Elsevier Ireland Ltd. All rights reserved.)

Objectives: To overview and summarize the results emerging from the studies on adjunctive devices (AD) with theoretical anti-embolic properties in patients with ST-elevation acute myocardial infarction (STEMI) undergoing percutaneous coronary interventions (PCI)., Background: A series of small-to-medium size randomized studies have compared different AD with standard PCI (SP) in the setting of STEMI. The reported results are conflicting., Methods: Eighteen prospective randomized studies on 3180 STEMI patients comparing AD with SP were identified and entered the meta-analysis. Pre-specified angiographic, electrocardiographic (absence of ST-segment resolution, STR) and early (up to 30 days) clinical end-points were assessed., Results: AD were associated with lower rates of angiographically evident distal embolization: OR (95% CI): 0.54 (0.37-0.81). Analyses of angiographic and electrocardiographic reperfusion showed striking heterogeneity among studies and an overall trend toward better results with AD: OR (95% CI) 0.76 (95% CI 0.51-1.12) for TIMI<3, 0.53 (0.37-0.76) for myocardial blush grade (MBG)<3, 0.60 (0.45-0.78) for absence of STR. Subgroup analysis according to the type of AD for the end-point of no STR showed concordant absence of benefit in studies testing distal protection devices, positive results being confined to the studies using thrombectomy devices (OR 0.46, 95% CI 0.32-0.66). However, the possibility of a "small study" bias within thrombectomy studies cannot be discharged (significant heterogeneity and positive Egger's test). Early major adverse cardiac events were not different between AD and SP., Conclusions: AD use may be associated with reduced rate of angiographic distal embolization, and improved MBG 3 and STR rates. However, efficacy might vary with the type of device employed. Moreover, early clinical outcome is not modified suggesting that further, larger, studies are needed to assess the clinical impact of AD., Condensed Abstract: We conducted a meta-analysis of 18 prospective randomized trials comparing adjunctive devices (AD) with standard PCI in the setting of STEMI. The use of AD was associated with lower rates of (angiographically evident) distal embolization. Analyses of angiographic and electrocardiographic reperfusion showed striking heterogeneity and an overall trend toward better results with AD. Subgroup analysis suggested that different types of device may have different effects. Early major adverse cardiac events were similar between AD and SP.

Background: Systemic inflammation is involved in several pathological cardiovascular processes. However, whether it plays a role in the no-reflow phenomenon occurring in patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI) is unknown., Methods: We studies 60 consecutive patients (59.5+/-12 years, 82% males) with a first ST-segment elevation AMI, treated by primary or rescue PCI within 6 h of symptom onset. Angiographic indexes of no-reflow, evaluated at the end of the procedure, included coronary TIMI flow grading, corrected TIMI frame count (c-TFC) and myocardial blush grade (MBG). ECG indexes of no-reflow included the lack of ST segment resolution (defined as a reduction <50% of the measured ST-segment elevation at 90 min, compared to the admission ECG), as analyzed both in the single lead with the maximal ST elevation and in all leads showing ST elevation on admission. Patients were divided into two groups according to baseline high-sensitivity C-reactive protein (CRP) serum levels measured on admission: high CRP group (CRP>5 mg/L) and low CRP group (CRP<5 mg/L)., Results: A similar prevalence of final TIMI flow<3 and MBG<3 was observed in patients with high and low CRP serum levels (30% vs. 12%, p=0.1, and 50% vs. 53%, p=1.0, respectively), and c-TFC was also similar in the two groups (26+/-4.5 vs. 24+/-6, p=0.5). Accordingly, the prevalence of lack of ST-segment resolution in the two groups was similar, both by the single-lead method (25% vs. 25%, p=1.0) and the multiple-lead method (29% vs. 19%, p=0.4)., Conclusion: In this study we failed to demonstrate any significant association between CRP serum levels on admission and coronary no-reflow, as assessed by both angiographic and ECG parameters in AMI patients treated by successful primary or rescue PCI within 6 h of chest pain onset.

Plaque debulking before stenting is still controversial. We performed a meta-analysis of 12 randomized and non-randomized trials comparing directional coronary atherectomy (DCA) before stenting versus stenting alone. Angiographic end points were acute gain, late loss and angiographic restenosis rate. Clinical end points were early major adverse cardiac events [MACEs: death, Q-wave myocardial infarction (MI), non-Q-wave MI], late MACEs (death, Q-wave MI) and target lesion revascularization (TLR). Data are expressed as odds ratio (OR) with 95% confidence intervals (CI) or weighted mean difference (WMD) with 95% CI, as appropriate. A total of 1216 patients undergoing DCA before stent and 1484 patients undergoing stent alone have been included. DCA before stent was associated to a better acute gain compared to stenting alone (WMD 0.23, [0.18-0.28]; p<0.0001), to a striking reduction of angiographic restenosis rate (OR of 0.67, [0.54-0.84], p=0.0003) and to a significantly lower rate of late TLR (OR 0.73 [0.59-0.91], p=0.006). Late loss did not differ between the two groups (WMD 0.00 [-0.08 and 0.08], p=0.98). We found a higher rate of early MACEs for the combined approach (OR 1.87 [1.16-3.02], p=0.01), with similar prevalence of late MACEs (OR 0.83 [0.65-1.06], p=0.13). In conclusion, this meta-analysis demonstrates that DCA before stenting is superior to stenting alone with regard to acute angiographic results and TLR with a similar prevalence of late MACEs. The higher prevalence of early MACEs with DCA before stenting, however, is disturbing and probably related to distal embolization.

Background: Recent data suggest that the intracoronary (i.c.) administration of a systemic bolus dose of abciximab during PCI may increase the efficacy of this antiplatelet drug. However, the effect of i.c. abciximab on coronary angiographic flow has been not clarified., Methods: We studied 37 consecutive patients with acute coronary syndromes (ACS) who underwent successful urgent PCI on the target vessel and were treated by an i.c. abciximab bolus (0.25 mg/kg) prior to the first balloon inflation (Group IC), and 37 matched controls who were treated by intravenous (i.v.) abciximab bolus at the same dose (Group IV). Corrected TIMI frame count (CTFC) in the culprit and in a non-culprit coronary artery branch was assessed before treatment, immediately after intracoronary administration of abciximab bolus and at the end of the procedure., Results: After administration of abciximab, CTFC significantly decreased from 48+37 to 33+30 (P=0.001) in the culprit vessel while in the non-culprit vessel it remained unchanged (16+7 pre-treatment and 16+7 post-treatment, P=0.68). Final CTFC was 12+4 in Group IC and 14+5 in Group IV (P=0.069). Post-treatment mean peak of the cardiac enzymes showed a trend toward reduction in Group IC compared with Group IV., Conclusions: The i.c. administration of abciximab bolus acutely decreases CTFC through culprit vessels of patients with ACS undergoing urgent PCI. Further studies evaluating the potential clinical benefits associated with i.c. abciximab administration are warranted.