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Abstract: Cardiogenic shock (CS) is a life-threatening condition. The aim of this study is to evaluate the clinical characteristics, management, and complication rate of patients with CS admitted to a high-volume hospital in Italy. We retrospectively reviewed the clinical, echocardiographic, and laboratory data, therapeutic management, and outcomes of patients with CS admitted to the Policlinico Gemelli (Rome) between January 1, 2020, and January 1, 2023. We included 96 patients [median age 71 years, interquartile range 60-79; 65 (68%) males], of whom 49 patients (51%) presented CS secondary to acute myocardial infarction and 60 (63%) with a de novo presentation of CS. Dobutamine was the most frequently used inotrope and noradrenaline the most frequently used vasopressor (adopted in 56% and 82% of cases, respectively). Forty-five (47%) patients died during the hospitalization. Nonsurvivors were older and had a higher inflammatory burden at admission, elevated lactate levels, a greater increase in lactate levels, higher left ventricular filling pressures, and worse right ventricular function. C-reactive protein levels [odds ratio (OR) 1.03, 95% confidence interval (CI) (1.00-1.04), P = 0.027], lactate levels at admission (OR 3.49, 95% CI, 1.59-7.63, P = 0.02), and increase in lactate levels (OR 2.8, 95% CI, 1.37-5.75, P = 0.005) were independent predictors of in-hospital all-cause death. Our data contribute to the assessment of the regional variations in the management and outcomes of patients with CS. We observed a high mortality and complication rate. Lactate acidosis and C-reactive protein measured at admission may help in identifying patients at higher risk of adverse in-hospital outcomes., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Increased body mass index (BMI) is an established cardiovascular risk factor. The impact of high BMI on vascular and bleeding complications in patients undergoing transcatheter aortic valve implantation (TAVI) is not clarified. RISPEVA, a multicenter prospective database of patients undergoing TAVI stratified by BMI was used for this analysis. Patients were classified as normal or high BMI (obese and overweight) according to the World Health Organization criteria. A comparison of 30-day vascular and bleeding outcomes between groups was performed using propensity scores methods. A total of 3776 matched subjects for their baseline characteristics were included. Compared with normal BMI, high BMI patients had significantly 30-day greater risk of the composite of vascular or bleeding complications (11.1% vs 8.8%, OR: 1.28, 95% CI [1.02 to 1.61]; p = 0.03). Complications rates were higher in both obese (11.3%) and overweight (10.5%), as compared with normal weight patients (8.8%). By a landmark event analysis, the effect of high versus normal BMI on these complications appeared more pronounced within 7 days after the TAVI procedure. A significant linear association between increased BMI and vascular complications was observed at this time frame (p = 0.03). In conclusion, compared with normal BMI, both obese and overweight patients undergoing TAVI, experience increased rates of 30-day vascular and bleeding complications. These findings indicate that high BMI is an independent risk predictor of vascular and bleeding complications after TAVI., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) has become first-line treatment for severe aortic valve stenosis in patients with moderate, high or prohibitive surgical risk. However, access site complications may occur more frequently in extreme body mass index (BMI) categories. The aim of this study was to describe the features and outcomes of patients undergoing TAVI in a comprehensive Italian prospective clinical registry, focusing on BMI classes., Methods: A national prospective database was queried for baseline, procedural, and outcome details of patients undergoing TAVI according to established BMI categories: underweight (BMI <18.5 kg/m 2 ), normal weight (BMI 18.5-24.9 kg/m 2 ), overweight (BMI 25.0-29.9 kg/m 2 ), and obese (BMI≥30 kg/m 2 ). Short- and long-term outcomes, including major adverse events (MAE), i.e. the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure, were appraised with bivariate and multivariable analyses., Results: A total of 3075 subjects were included, 64 (2.1%) were underweight, 1319 (42.9%) were normal weight, 1152 (37.4%) were overweight, and 540 (17.6%) were obese. Several baseline differences were evident, including gender, diabetes mellitus, renal function, chronic obstructive pulmonary disease, surgical scores, and left ventricular ejection fraction (LVEF) (all P<0.05). Several procedural differences were also evident, including percutaneous approach, predilation, prosthesis type and size (all P<0.05), with postprocedural aortic regurgitation >2+ significantly more common in underweight patients (P<0.05). Nonetheless, unadjusted analysis for one-month outcomes showed similar rates for fatal and non-fatal outcomes, including MAE (all P>0.05), with the notable exception of permanent pacemaker implantation, which was more common in higher BMI classes (P=0.010) Unadjusted analysis for long-term events showed an increased rate of death in underweight patients (P=0.024). Multivariable adjusted analysis confirmed the increased risk of permanent pacemaker implantation in obese patients (P=0.015 when comparing obese vs. normal weight subjects), but disproved differences in long-term mortality and other outcomes (P>0.05 for all comparisons)., Conclusions: Irrespective of BMI class, TAVI is associated with favorable outcomes in surgical high-risk risk patients, with the notable exclusion of permanent pacemaker implantation, which is significantly more common in obese subjects.

Aims: Killip classification is a simple and fast clinical tool for risk stratification of patients presenting with acute coronary syndrome (ACS). However, the clinical features and predictors of high Killip class at admission, and its prognostic impact in patients presenting with anterior ST elevation MI (STEMI) as first clinical cardiovascular event are still poorly known. The aim of this study was to identify the predictors of high Killip class and its impact on in-hospital and follow-up outcomes., Methods: We prospectively enrolled patients with unheralded anterior STEMI because of proximal or mid left anterior descending (LAD) artery categorized according to Killip classification. Patients' characteristics, in-hospital complications and major adverse cardiovascular events (MACEs; composite of all-cause death, heart failure hospitalization and new-onset ACS) at follow-up were collected., Results: We enrolled 147 patients [age 66.16±13.33, 113 male patients (76.9%)]. Killip class III--IV occurred in 22 (15%) patients. The median duration of follow-up was 12 [6--15.1] months. At multivariate analysis age [hazard ratio 1.137, 95% CI (1.068--1.209), P < 0.001], prehospital cardiac arrest [hazard ratio 12.145, 95% CI (1.710--86.254), P = 0.013] and proximal LAD lesion [hazard ratio 5.066, 95% CI (1.400--18.334), P = 0.013] were predictive of Killip class III--IV at admission. At multivariate analysis, Killip class III--IV was an independent predictor of in-hospital mortality [hazard ratio 7.790, 95% CI (1.024--59.276], P = 0.047 and of MACEs [hazard ratio 4.155 (1.558--11.082), P = 0.004) at follow-up., Conclusion: Killip classification performed at the time of admission is a simple and useful clinical marker of a high risk of early and late adverse cardiovascular events., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. 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.)

The ACC/TVT score is a specific predictive model of in-hospital mortality for patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to test its predictive accuracy in comparison with standard surgical risk models (Logistic Euroscore, Euroscore II, and STS-PROM) in the population of TAVI patients included in the multicenter RISPEVA (Registro Italiano GISE sull'impianto di Valvola Aortica Percutanea) registry. The study cohort included 3293 patients who underwent TAVI between 2008 and 2019. The 4 risk scores were calculated for all patients. For all scores, the capability to predict 30-day mortality was assessed by means of several analyses testing calibration and discrimination. The ACC/TVT score showed moderate discrimination, with a C-statistics for 30-day mortality of 0.63, not significantly different from the standard surgical risk models. The ACC/TVT score demonstrated, in contrast, better calibration compared with the other scores, as proved by a greater correspondence between estimated probabilities and the actual observations. However, when the ACC/TVT score was tested in the subgroup of patients treated in a more contemporary period (from 2016 on), it revealed a slight tendency to lose discrimination and to overestimate mortality risk. In conclusion, in comparison with the standard surgical risk models, the ACC/TVT score demonstrated better prediction accuracy for estimation of 30-day mortality in terms of calibration. Nevertheless, its predictive reliability remained suboptimal and tended to worsen in patients treated more recently., (Copyright © 2020. Published by Elsevier Inc.)

Refractory cardiogenic shock (RCS) or refractory cardiac arrest (RCA) complicating acute coronary syndrome (ACS) is associated with extremely high mortality rate. Veno-arterial extracorporeal life support (VA-ECLS) represents a valuable therapeutic option to stabilize patients' condition before or at the time of emergency revascularization. We analyzed 29 consecutive patients with RCS or RCA complicating ACS, and implanted with VA-ECLS in two centers who have adopted a similar, structured approach to ECLS implantation. Data were collected from January 2010 to December 2015 and ECLS had to be percutaneously implanted either before (within 48 h) or at the time of attempted percutaneous coronary revascularization (PCI). We investigated in-hospital outcome and factors associated with survival. Twenty-one (72%) were implanted for RCA, whereas 8 (28%) were implanted on ECLS for RCS. All RCA were witnessed and no-flow time was shorter than 5 min in all cases but one. All patients underwent attempted emergency PCI, using radial access in ten cases (34.5%), whereas in three patients a subsequent CABG was performed. Overall, ten patients (34.5%) survived, nine of them with a good neurological outcome. Life threatening complications, including stroke (4 pts), leg ischemia (4 pts), intestinal ischemia (5 pts), and deep vein thrombosis 2 pts), occurred frequently, but were not associated with in-hospital death. Main cause of death was multi-organ failure. PCI variables did not predict survival. Survivors were younger, with shorter low-flow time, and with ECLS mainly implanted for RCS. At multivariate analysis, levels of lactate at ECLS implantation (OR 4.32, 95%CI 1.01-18.51, p = 0.049) emerged as the only variable that independently predicted survival. In patients with RCA or RCS complicating ACS who are percutaneously implanted with ECLS before or at the time of coronary revascularization, in hospital survival rate is higher than 30%. Level of lactate at ECLS implantation appears to be the most important factor to predict survival.

Background: Strong epidemiologic evidence has highlighted the role of pollution, on top of adverse climate features, as a novel cardiovascular risk factor. However, mechanistic proof that reducing pollution may be beneficial to prevent atherothrombotic events is limited. We aimed at appraising the impact of temporary traffic bans in a large metropolitan area on the risk of acute coronary syndromes., Methods: Aggregate and anonymized data from 15 tertiary cardiac care centers were obtained detailing precoronavirus disease 2019 (COVID-19) daily cases of ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI), including those treated with percutaneous coronary intervention (PCI). Data on pollutants and climate were sought for the same days. Mixed level regression was used to compare the week before vs after the traffic ban (Fortnight analysis), the 3 days before vs. after (Weekly analysis) and the Sunday before vs. after (Sunday analysis)., Results: A total of 8 days of temporary traffic bans were included, occurring between 2017 and 2020, totaling 802 STEMI and 1196 NSTEMI in the Fortnight analysis, 382 STEMI and 585 in the Weekly analysis, and 148 STEMI and 210 NSTEMI in the Sunday analysis.Fortnight and Sunday analyses did not disclose a significant impact of traffic ban on STEMI or NSTEMI (all P>0.05). Conversely, Weekly analysis showed non-significant changes for STEMI, but a significant decrease in daily NSTEMI when comparing the 3 days before the traffic ban with the ban day (P=0.043), as well as the 3 days before vs. the 3 days after the ban (P=0.025). No statistically significant effect of traffic ban was found at Fortnight, Weekly or Sunday analyses for daily mean concentrations of benzene, carbon monoxide, nitric oxide, nitrogen dioxide, ozone, sulfur dioxide, particulate matter (PM) <2.5 µm or PM <10 µm (all P>0.05). However, minimum daily concentrations showed a significant reduction of ozone during the ban in comparison to the week preceding it (P=0.034), nitric oxide during the ban in comparison to the 3 days preceding it (P=0.046), and an increase in benzene during the ban in comparison to the Sunday before (P=0.039)., Conclusions: Temporary traffic ban may favorably reduce coronary atherothrombotic events, and in particular NSTEMI, even if not globally and immediately impacting on environmental pollution. Further controlled studies are required to confirm and expand this hypothesis-generating results.

Objective: The objective is to analyze the acute and midterm angiographic outcome of percutaneous treatment of left main coronary stem (LM-PCI) guided by optical coherence tomography (OCT)., Background: LM-PCI is a complex procedure, and several anatomical factors may impair its outcome. Intravascular imaging is emerging as a useful tool to guide the procedure., Methods: We conducted a retrospective analysis of patients undergoing LM-PCI at three European centers between 2014 and 2017 with a control angiography at 6-12 months. Patients were divided into two groups: OCT-guidance (pre- and post-PCI) and control group (standard angiographic guidance with/out intravascular ultrasound [IVUS]). A blinded core lab analyzed all angiographic images. Primary endpoint was late lumen loss (LLL) after 6 months., Results: A total of 112 patients entered the study, 55 in the OCT group and 57 in the control group (10 IVUS). Baseline and procedural characteristics were similar between groups. Overall, reference vessel diameter of the LM was 3.98 ± 0.65 mm. OCT guidance detected four cases of stent underexpansion (7.2%) and six cases of acute malapposition (10.9%). After a median of 207 ± 23 days, LLL of LM tended to be lower in the OCT group (0.12 ± 0.41 vs. 0.26 ± 0.52 mm, p = .10), and was significantly reduced in the distal portion of the main vessel (0.03 ± 0.45 vs. 0.24 ± 0.53 mm, p = .025). Percent diameter stenosis was also lower (14 ± 9 vs. 19 ± 16%, p = .05). Adverse event rates were similar in the two groups., Conclusions: In this study, systematic OCT guidance during LM-PCI allowed a timely detection and correction of acute stent underexpansion and malapposition, and was associated with signs of improved angiographic outcome at midterm, compared to standard practice., (© 2019 Wiley Periodicals, Inc.)

Aims: The aim of this study was to investigate nationwide trends and clinical outcomes of the Impella device for cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI)., Methods and Results: The IMP-IT study was a multicentre observational national registry which enrolled all patients treated with Impella 2.5, Impella CP, Impella 5.0 and Impella RP, both for CS and HR-PCI indications, across 17 Italian centres from 2004 to June 2018. A total of 406 patients were included: 229 had CS (56.4%) and 177 underwent HR-PCI (43.6%). The use of Impella increased significantly during the study period (average annual percent change 39.8%, 95% confidence interval: 30.4 to 49.9; p<0.0001) for both indications. The Impella 2.5 was the most commonly used device (N=242; 59.6%). Rates of in-hospital and one-year all-cause death in patients with CS were 46.9% and 57.0%, respectively; 18.5% underwent left ventricular assist device implantation or heart transplant at one year. Rates of in-hospital and one-year all-cause death in patients who underwent HR-PCI were 5.7% and 15.6%, respectively. Rates of device-related complications were 37.1% and 10.7% in the setting of CS and HR-PCI, respectively., Conclusions: Use of the Impella for CS and HR-PCI is increasing substantially in Italy, despite relatively high rates of device-related complications.

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.)

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.)

Aim: To assess the impact of lesion predilation with kissing inflation using under-sized balloons (pre-kissing [PK]) on the procedural outcome of percutaneous intervention (PCI) on coronary bifurcation lesions (CBLs)., Methods: Patients who underwent PCI with second-generation drug-eluting stenting on a complex CBL (Medina 1,1,1 or 1,0,1 or 0,1,1) were selected. The study population was divided according to the lesion preparation into the PK group and the control group. To adjust for higher anatomic complexity of PK patients, a 2:1 propensity-matched (PM)-control group was selected. The PCI procedural details were assessed to evaluate occurrence of "side-branch trouble" (primary procedural endpoint) after main-vessel (MV) stenting. Angiographic characteristics, including side-branch TIMI flow during PCI, were also systematically evaluated., Results: A total of 538 patients were identified, with 66 patients in the PK group, 472 patients in the control group, and 126 patients in the PM-control group. Side-branch trouble was less common in side-branch PK patients vs the PM-control patients (7.5% vs 18.0%, respectively; P=.03). In multivariable analysis, the absence of PK independently predicted side-branch trouble. Among selected patients with a long side-branch lesion (122 patients), the PK technique improved post-MV stenting side-branch TIMI flow., Conclusions: Use of PK with under-sized balloons may facilitate side-branch management after MV stenting in patients with complex CBL undergoing provisional stenting.

Background The role of endothelial dysfunction in predicting angina recurrence after percutaneous coronary intervention is unknown. Design We assessed the role of peripheral endothelial dysfunction measured by reactive-hyperaemia peripheral-artery tonometry (RH-PAT) in predicting recurrence of angina after percutaneous coronary intervention. Methods We enrolled consecutive patients undergoing percutaneous coronary intervention with second-generation drug-eluting stents. RH-PAT was measured at discharge. The endpoint was repeated coronary angiography for angina recurrence and/or evidence of myocardial ischaemia at follow-up. Patients with in-stent restenosis and/or significant de novo stenosis were defined as having angina with obstructed coronary arteries (AOCA); all other patients as having angina with non-obstructed coronary arteries (ANOCA). Results Among 100 patients (mean age 66.7 ± 10.4 years, 80 (80.0%) male, median follow-up 16 (3-20) months), AOCA occurred in 14 patients (14%), ANOCA in nine patients (9%). Repeated coronary angiography occurred more frequently among patients in the lower RH-PAT index tertile compared with middle and upper tertiles (14 (41.2%) vs. 6 (18.2%) vs. 3 (9.1%), p = 0.006, respectively). ANOCA was more frequent in the lower RH-PAT index tertile compared with middle and upper tertiles. In the multivariate regression analysis, the RH-PAT index only predicted angina recurrence. The receiver operating characteristic curve of the RH-PAT index to predict the angina recurrence demonstrated an area under the curve of 0.79 (95% confidence interval: 0.69-0.89; p < 0.001), with a cut-off value of 1.705, having sensitivity 74% and specificity 70%. Conclusions Non-invasive assessment of peripheral endothelial dysfunction using RH-PAT might help in the prediction of recurrent angina after percutaneous coronary intervention, thus identifying patients who may need more intense pharmacological treatment and risk factor control.

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of patients with symptomatic severe aortic stenosis and has become the standard of care for inoperable patients and the preferred therapy for those at increased surgical risk with peculiar clinical and anatomic features. Technology advances, growing experience and accumulating data prompted the update of the 2011 Italian Society of Interventional Cardiology (SICI-GISE) position paper on institutional and operator requirements to perform TAVI. The main objective of this document is to provide a guidance to assess the potential of institutions and operators to initiate and maintain an efficient TAVI program.

Background: Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES) on unprotected left main (ULM) represent a complex subset. The role of routine coronary angiography at follow up in this subset remains debated., Methods: At the documented center, all patients undergoing successful PCI on ULM lesions performing angiographic follow-up is suggested, but adherence to such a recommendation is inhomogeneous. Consecutive patients undergoing DES PCI on ULM were enrolled and experienced no adverse events during the first 6 months. Patients were then allocated to two groups: those undergoing routine control angiography (CA) and those undergoing clinical follow-up (CF). Primary endpoint was major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction and urgent repeat target vessel revascularization., Results: A total of 190 patients underwent successful DES implantation on ULM and the study population was without early events. CA was performed at 6 months after the index procedure in 91 (48%) patients. After 35 ± 21 months, MACE rates were significantly more common in the CF group as compared with the CA group (16.2% vs. 4.3%, p = 0.009). At multivariable analysis, CA was associated with reduced MACE risk (HR 0.13, 95% CI 0.1-0.7, p = 0.028). Of note, this was mainly driven by higher cardiac death rate in those undergoing CF than in those undergoing CA (p = 0.01)., Conclusions: CA after complex PCI, such as ULM PCI, is associated with reduced MACE. Such an observation calls for appropriately designed randomized trials.

Objectives: to understand the role of a transradial (TR) secondary approach during complex percutaneous interventions., Background: The value of the TR route for ancillary vascular approach has not been adequately validated in this setting, and there is scant data on its role in reducing bleeding complications., Methods: In the present study we retrospectively included patients undergoing the following interventions requiring two vascular approaches at nine high-volume centers in Italy: structural cardiac interventions, complex PCI, endovascular aortic repair (EVAR) and complex lower limb angioplasty. We compared procedural outcomes according to the type of ancillary vascular approach selected, namely TR or transfemoral/transbrachial (TF/TB). Primary endpoints of the study were procedural success and in-hospital BARC grade 3-5 bleedings., Results: We included 906 patients, 433 receiving TR and 473 TF/TB ancillary approaches. Baseline characteristics did not differ significantly. Patients underwent the following types of intervention: structural 50%, complex coronary PCI 37%, EVAR 11%, peripheral angioplasty 2%. Procedural success was similar (90% in TR and 92% TF/TB, P = NS). In-hospital BARC 3/5 bleedings were more common in TF/TB group as compared to TR group (19.7% vs. 6.7%,P < 0.001). In TF/TB group we also observed a higher postprocedural hemoglobin drop (1.92 vs 1.13 g/dl, P = 0.008) and longer hospital stay as compared to TR group. Similar results were observed in a propensity score-matched population of 450 patients., Conclusions: In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex structural, coronary, and peripheral percutaneous interventions. The value of the transradial route for ancillary vascular approach during percutaneous interventions has not been adequately validated yet. We retrospectively included 906 patients, 433 receiving TR and 473 TF/TB ancillary approach at nine high-volume centers for the following interventions: structural cardiac interventions, complex PCI, EVAR and complex peripheral angioplasty. Procedural success was similar, whereas in-hospital BARC bleedings were more common in the transfemoral/brachial group. Similar results were observed in a propensity score-matched population. In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex interventions. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

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.)

Objectives: The goal of this study was to assess the clinical impact of optical coherence tomography (OCT) findings during percutaneous coronary intervention (PCI)., Background: OCT provides unprecedented high-definition visualization of plaque/stent structures during PCI; however, the impact of OCT findings on outcome remains undefined., Methods: In the context of the multicenter CLI-OPCI (Centro per la Lotta contro l'Infarto-Optimisation of Percutaneous Coronary Intervention) registry, we retrospectively analyzed patients undergoing end-procedural OCT assessment and compared the findings with clinical outcomes., Results: A total of 1,002 lesions (832 patients) were assessed. Appropriate OCT assessment was obtained in 98.2% of cases and revealed suboptimal stent implantation in 31.0% of lesions, with increased incidence in patients experiencing major adverse cardiac events (MACE) during follow-up (59.2% vs. 26.9%; p < 0.001). In particular, in-stent minimum lumen area <4.5 mm(2) (hazards ratio [HR]: 1.64; p = 0.040), dissection >200 μm at the distal stent edge (HR: 2.54; p = 0.004), and reference lumen area <4.5 mm(2) at either distal (HR: 4.65; p < 0.001) or proximal (HR: 5.73; p < 0.001) stent edges were independent predictors of MACE. Conversely, in-stent minimum lumen area/mean reference lumen area <70% (HR: 1.21; p = 0.45), stent malapposition >200 μm (HR: 1.15; p = 0.52), intrastent plaque/thrombus protrusion >500 μm (HR: 1.00; p = 0.99), and dissection >200 μm at the proximal stent edge (HR: 0.83; p = 0.65) were not associated with worse outcomes. Using multivariable Cox hazard analysis, the presence of at least 1 significant criterion for suboptimal OCT stent deployment was confirmed as an independent predictor of MACE (HR: 3.53; 95% confidence interval: 2.2 to 5.8; p < 0.001)., Conclusions: Suboptimal stent deployment defined according to specific quantitative OCT criteria was associated with an increased risk of MACE during follow-up., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. 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: This study sought to assess whether intracoronary adenosine or nitroprusside following thrombus aspiration (TA) is superior to TA alone for the prevention of microvascular obstruction (MVO) in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI)., Background: MVO, due to its multifactorial pathogenesis, still occurs after TA in a sizeable portion of patients., Methods: We performed a placebo-controlled, randomized, open-label, blind-examination, multicenter trial. A total of 240 STEMI patients with Thrombolysis In Myocardial Infarction (TIMI) flow grade 0/1 were randomly allocated 1:1:1 to receive adenosine (n = 80), nitroprusside (n = 80), or saline (n = 80) given distal to the occluded site after TA. The primary endpoint was the incidence of ST-segment resolution (STR) >70% on surface electrocardiogram at 90 min after PCI. Secondary endpoints were angiographic MVO incidence (TIMI flow grade ≤2 or 3 with a myocardial blush grade <2) and major adverse cardiac event (MACE) rate at 30 days as a composite of cardiac death, myocardial infarction, target lesion revascularization, and heart failure requiring hospitalization., Results: STR >70% occurred in in 71% of adenosine-treated patients, in 54% of nitroprusside-treated patients, and in 51% of saline-treated patients (p = 0.009 and p = 0.75, respectively, vs. saline). Angiographic MVO occurred in 18% of adenosine-treated patients, in 24% of nitroprusside-treated patients, and in 30% of saline-treated patients (p = 0.06 and p = 0.37, respectively, vs. saline). MACE occurred in 10%, 14%, and 20% of patients, respectively (p = 0.08 and p = 0.29 vs. saline)., Conclusions: In STEMI patients treated by PCI and TA, the additional intracoronary administration of adenosine, but not that of nitroprusside, results in a significant improvement of MVO, as assessed by STR., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of the study was to compare outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein graft (SVG) interventions in a case-control study with a long-term follow-up., Background: Safety and efficacy of DES in SVG interventions are still controversial., Methods: We performed a multicenter registry assessing clinical outcomes with DES vs. BMS. We included 311 patients (239 men, age 68 ± 8 years) who underwent percutaneous coronary interventions (PCI) of SVG lesions with DES (n = 138) or BMS (n = 173) with a 2-year follow-up., Results: The two groups were similar for age, sex, main risk factors, incidence of diabetes, use of IIb/IIIa antagonists, use of aspiration devices or filters, number of stents, and total stent length. Overall, at 9 months follow-up incidence of major adverse cardiac events (MACE) and target vessel revascularization (TVR) were significantly lower in the DES group compared with the BMS group (10.9% vs. 22.0%, P = 0.014 and 8.7% vs. 19.1% in DES and BMS respectively, P = 0.015), while there was no significant difference in incidence of myocardial infarction (5.1% vs. 5.2%, P = 0.96) or death (2.2% vs. 4%, respectively, P = 0.54). However, at 24-month follow-up incidence of MACE was 29.7% in the DES group and 37.0% in BMS group (P = 0.29); incidence of TVR (23.2% vs. 28.9% P = 0.39), myocardial infarction (9.4% vs. 9.2%), death (7.2% vs. 6.9%) were also similar in the two groups., Conclusions: Although DES appear safe, our findings suggest that the early benefit of DES in SVG may rapidly wane during long-term follow-up., (Copyright © 2012 Wiley Periodicals, Inc.)

Aims: Contrast-induced nephropathy (CIN) is a frequent and potentially harmful complication of percutaneous coronary interventions (PCI), especially in the setting of ST-elevation myocardial infarction (STEMI). We tested the efficacy of a sodium bicarbonate (SB)-based hydration in urgent PCI for STEMI., Methods and Results: From June 2009 to September 2010, 262 consecutive STEMI patients undergoing urgent PCI were prospectively enrolled and treated by SB-based hydration (154 mEq/L at 3 ml Kg-1 for one hour followed by 1 ml Kg-1 for six hours) (group A). As controls, 262 consecutive STEMI patients receiving 0.9% saline hydration (1 ml Kg-1 for 24 hours) before June 2009 were retrospectively enrolled (group B). Both groups received high-dose N-acetylcysteine (NAC). The primary endpoint was the composite of in-hospital death, need for dialysis and CIN (≥25% increase in serum creatinine at 48 hours). The two groups were comparable for baseline clinical and procedural characteristics, for Mehran risk score and baseline estimated glomerular filtration rate. The primary combined endpoint was significantly reduced in group A as compared to group B (9.2 vs. 18.7%, p=0.023) with a number needed to treat (NNT) of 11. Specifically, a significant reduction of both in-hospital death (2.3 vs. 6.1%, p=0.049, NNT 27) and CIN (8.0 vs. 14.1%, p=0.03, NNT 17) was observed, with no difference in the need for dialysis., Conclusions: Our data indicate that hydration with sodium bicarbonate in addition to high-dose NAC in the setting of urgent PCI for STEMI is associated with a net clinical benefit.

Background: Women have a worse outcome than men after percutaneous coronary intervention (PCI). However, in the drug-eluting stent (DES) era, limited data are available about the impact of gender-related differences on clinical outcome. Furthermore, many series have also included patients previously treated by coronary-artery bypass grafts or PCI, which may bias the evaluation of DES-related clinical events at follow up. We aimed to assess the impact of gender on clinical outcomes in a consecutive series of patients at first manifestation of coronary artery disease (CAD) undergoing PCI with mTOR-inhibitor DES., Methods and Results: A total of 138 consecutive patients (age 64 ± 13 years, female gender 29%) undergoing successful mTOR-inhibitor DES implantation [sirolimus-eluting stent (SES); zotarolimus-eluting stent (ZES); and everolimus-eluting stent (EES)] for the treatment of stable chronic angina or an acute coronary syndrome, as their first clinical manifestation of CAD, were prospectively enrolled between February 2008 and May 2009. Major adverse cardiac events (MACE), defined as a combination of cardiac death, myocardial infarction (MI), and clinically driven target lesion revascularization (TVR) at 12-month follow up, constituted the endpoint of the study. Fifty-one (37%) patients received SES; 46 (33%) patients received ZES; and 41 (30%) patients received EES. At follow up, 21 (15%) patients experienced a MACE. Three (2%) patients had cardiac death, five (4%) had MI, while 13 (9%) patients underwent clinically driven TVR. MACE occurred more frequently in females than males [10 (25%) vs. 11 (11%), p = 0.05]. At Cox regression analysis, the only independent predictors of MACE were female gender and implantation of more than one stent [hazard ratio (HR) 3.70, 95% confidence interval (CI) 1.46-9.36, p = 0.006; HR 1.26, 95% CI 0.99-2.74, p = 0.01, respectively]., Conclusions: In conclusion, our finding suggests that women may have a worse outcome as compared with men after mTOR-inhibitor DES implantation.

Background: Neointimal hyperplasia plays a pivotal role in the pathogenesis of in-stent restenosis in patients undergoing percutaneous coronary interventions. Drug-eluting balloons are a promising tool to prevent restenosis after coronary angioplasty. Moreover, an increased knowledge of the pathophysiology of restenosis my help improve therapeutic strategies., Methods/design: We present the design of an open-label, randomized three-arm clinical trial aimed to assess whether a strategy of bare-metal stent implantation with additional use of drug-eluting balloons, either before (pre-dilation) or after stenting (post-dilation), reduces the primary endpoint of in-stent neointimal hyperplasia area as compared with a strategy of bare-metal stent implantation alone. This primary endpoint will be assessed by optical coherence tomography at follow-up. Secondary endpoints will be the percentage of uncovered struts, and the percentage of struts with incomplete apposition. An ancillary study investigating the relation between systemic levels of endothelial progenitors cells and neointimal hyperplasia, and the interaction between endothelial progenitors cell levels and drug-eluting balloons has been planned. Thirty consecutive patients undergoing percutaneous coronary intervention will be randomized with a 1:1:1 design to bare-metal stent implantation alone (n = 10); bare-metal stent implantation after pre-dilation with a drug-eluting balloon (n = 10); or bare-metal stent implantation followed by post-dilation with a drug-eluting balloon (n = 10). Six-month follow-up coronary angiography with optical coherence tomography imaging of the stented segment will be performed in all patients. Blood samples for the assessment of endothelial progenitors cell levels will be collected on admission and at 6 months., Discussion: Experimental and early clinical data showed that inhibition of neointimal hyperplasia may be obtained by local administration of antiproliferative drugs loaded on the surface of angioplasty balloons. The INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO) trial was conceived to test the superiority of a strategy of bare-metal stent implantation with additional drug-eluting balloon use (either before or after stenting) versus a strategy of bare-metal stent implantation alone for the reduction of neointimal hyperplasia. We also planned an ancillary study to assess the role of endothelial progenitors cells in the pathophysiology of neointimal hyperplasia., Trial Registration: Clinicaltrials.gov NCT01057563.

Background: Randomized trials have shown that transradial approach, compared with transfemoral, reduces vascular complications (VCs) of coronary procedures in selected patients. Yet, radial approach is associated to a variety of access-site VC as well as to a higher failure rate compared with femoral access., Methods: At our institution, from May 2005 to May 2010, we prospectively assessed the occurrence and outcome of VC in consecutive patients undergoing transradial percutaneous coronary procedures performed by trained radial operators. The need of access crossover to complete the procedure was also prospectively investigated. Vascular complications were classified as "radial related" or "nonradial related" (in the case of access crossover). Vascular complications were also classified "major" if requiring surgery and/or blood transfusions or causing hemoglobin drop >3 g/dL., Results: Ten thousand six hundred seventy-six procedures were performed using a right radial (87.5%), left radial (12.4%), or ulnar (0.1%) artery as primary access. A total of 53 VCs (0.5%) were observed: 44 (83%) radial related and 9 (17%) nonradial related. Major VCs occurred in 16 patients only (0.2%) and were radial related in 10 (62.5%) and nonradial related in 6 (37.5%) patients. Vascular complications rate was stable during the study and independent of operator's experience. Access crossover rate was 4.9%, differed according to the operator radial experience and significantly decreased over time., Conclusions: The present study, conducted in a center with high volume of radial procedures, shows that transradial approach is associated with a very low rate of VC, which is stable over time. On the contrary, access crossover rate decreased over time and differed according to operator (radial) experience., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Aims: To assess the main predictors and significance of filter no-reflow (FNR) in protected saphenous vein graft (SVG) percutaneous coronary intervention (PCI) and the effect of two different filter-based devices on FNR incidence. The phenomenon of FNR has been described as a transient impairment of blood flow due to debris plugging of a filter-based device used to shield the distal microvasculature during SVG PCI., Methods and Results: Fifty consecutive patients treated with SVG PCI were enrolled, using two different filter-based devices (FilterWire EZ™ [Boston Scientific, Natick, MA, USA] and SpiderRX® [Ev3, Plymouth, MN, USA]). We evaluated: 1) the value of clinical and angiographic variables for predicting FNR including the recently-described "degeneration score" (DS); 2) the predictive value of FNR for post-procedural (type IVa) myocardial infarction (MI); 3) the effect of filter type on incidence of FNR. FNR was observed in 30% of patients and was predicted by a higher DS at baseline (2.1±0.9 vs. 1.4±0.8, p=0.02, respectively) as well as by the type of filter used (54% vs. 23% in SpiderFX and FilterWire EZ, respectively, p=0.04). However, at multivariate analysis DS was the only independent predictor of FNR (OR 2.47, CI 95% 1.06-5.76, p=0.04). Graft age and FNR were found to be independent predictors of type IVa MI (OR 1.28; CI%E2%80%AF95% 1.01-1.64, p=0.04 and OR 15.69; CI%E2%80%AF95% 2.12-116.39, p=0.007, respectively)., Conclusions: FNR is a common complication of protected SVG stenting. FNR occurs mainly in grafts with a high degeneration score, and the presence of FNR predicts post-procedural myocardial infarction.

Drug-eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus-eluting stents (SES) showed better outcomes than paclitaxel-eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor-eluting stents in the treatment of bifurcation lesions according to the provisional T-stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus-eluting stents (ZES) were implanted in 53 patients and everolimus-eluting stents (EvES) in 62 patients. Primary end-point of the study was the 12-month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of > 50% restenosis on the main vessel or TIMI flow < 3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non-ST-segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed., (Copyright © 2010 Wiley-Liss, Inc.)

Aims: As data on the use of the latest-generation drugeluting stents (DES) in bifurcation interventions are lacking, we realized a multicenter registry to assess the procedural and clinical results obtained in patients with unselected bifurcated lesions treated with the novel zotarolimus-eluting Resolute stent (ZRS)., Methods and Results: Three Italian centers participated in the study. Consecutive patients with significant stenosis of bifurcated lesions undergoing DES implantation were treated with ZRS. The recommended technique was the "provisional TAP approach" [main-vessel (MV) stent implantation eventually followed by kissing balloon and sidebranch (SB) stenting according to TAP technique]. Clinical characteristics, procedural details and clinical follow-up data were prospectively recorded. Procedural success was defined as post-percutaneous coronary intervention visual stenosis > 20% on MV and TIMI 3 flow on both MV and SB. Primary endpoint was major adverse coronary events (cardiac death, myocardial infarction and target vessel revascularization) at 9-month follow up. A total of 180 patients were enrolled. The target lesion was located in the distal left main in 16% and in the left anterior descending artery in 52%. All but 3 cases were treated according to the provisional TAP approach (kissing balloon rate, 69%; overall SB stenting rate, 10.6%). Procedural success was obtained in 98.3% (3 failures due to final SB TIMI flow < 3). At 9-month follow up, the survival free from MACE was 97.8% (1 cardiac death and 3 repeat revascularizations)., Conclusion: The use of the latest-generation ZRS in unselected bifurcated lesions treated by a provisional approach is associated with excellent procedural results and with promising clinical outcomes.

Objectives: To investigate the role of renal stenting in selected patients with chronic ischemic heart disease and renal artery stenosis., Methods: Consecutive patients, with chronic ischemic heart disease and severe hypertension and/or impaired renal function undergoing renal stenting, were prospectively enrolled. Mid-term (at least 2 years) follow-up was performed to assess both changes in renal function [serum creatinine and estimated glomerular filtrate rate (eGFR)] and blood pressure (BP) control (number of required drugs) and to record the incidence of clinical major adverse events. Moreover, in the first consecutive 24 patients, out-of-range pressure values at 24-hr BP monitoring and GFR at renal scintigraphy were measured at baseline and 1 month after stenting., Results: Seventy patients treated by stenting on 86 renal arteries entered the study. Procedural success rate was 99% and no major complication occurred. At 2-year follow-up, both mean serum creatinine (-0.1 +/- 0.7 mg/dl at follow-up compared to baseline, P = 0.6) and eGFR (+3.7 +/- 23.5 ml/min/1.73m(2) at follow-up compared to baseline, P = 0.2) did not significantly change while the number of drugs required to control BP significantly decreased (2.7 +/- 0.8 to 2.2 +/- 0.7, P < 0.0001). In the subset of 24 patients evaluated at 1 month, GFR significantly increased (62 +/- 20 ml/min to 67 +/- 21 ml/min; P = 0.008) and the rate of the out-of-range systolic pressure values at 24-hr monitoring significantly decreased (51-33%, P = 0.005). Elevated baseline creatinine values and the presence of global renal ischemia were identified as predictors of poor outcome at the multivariate analysis., Conclusions: In selected patients with chronic ischemic heart disease and hypertension and/or renal insufficiency, renal stenting may be performed with very low periprocedural complications and results in unchanged renal function and improved BP control., ((c) 2010 Wiley-Liss, Inc.)

Objective: We evaluated the acute and long-term results of the use of a new intracardiac microaxial pump, the Impella Recover LP 2.5, during elective high-risk percutaneous coronary interventions in a two-centre registry., Methods: Ten consecutive patients with poor left ventricular function and multivessel or left main coronary artery disease were considered at high risk of haemodynamic compromise and underwent percutaneous coronary interventions with preintervention Impella implantation. Procedural complications, 30-day and 12-month clinical outcome were recorded. Left ventricular ejection fraction was assessed by echocardiography before procedure and after at least 6 months., Results: The Impella was implanted before percutaneous coronary interventions by femoral approach and percutaneous coronary interventions were successfully performed (by contra lateral femoral or radial approach) in all cases. After percutaneous coronary intervention, Impella was removed in all patients, and haemostasis was obtained by prolonged manual compression or by double suture device preimplantation technique. No access-site complication was observed and no patient required transfusions. One patient died after Impella removal due to acute stent thrombosis. The other patients had an uncomplicated in-hospital course and were discharged within 5 days. At 1-year follow-up, no patient died nor suffered acute myocardial infarction, whereas two patients underwent re-percutaneous coronary intervention. Left ventricular ejection fraction at follow-up increased significantly in this study population (from 31 +/- 7% to 41% +/- 13%, P = 0.02)., Conclusion: Our results support the feasibility and safety of Impella-assisted percutaneous coronary intervention in high-risk patients. Prospective randomized trials are needed to test the clinical impact of such an innovative approach.

Objectives: To describe a novel modification of the T-stenting technique and to report the bench test as well as the first clinical results obtained., Background: The best technique to treat bifurcated coronary lesions has not been defined., Methods: This novel modification of the T-stenting technique is based, after stenting of the main vessel (MV) and kissing balloon, on the intentional minimal protrusion of the side-branch (SB) stent within the MV. Final kissing balloon is performed using the balloon kept uninflated into the MV before SB stenting. The technique was tested in vitro and applied in two independent series of patients undergoing elective drug-eluting stent implantation on one bifurcated lesion. Bifurcated lesions were classified according to the Medina classification. Patients' outcome up to 9 month was prospectively assessed., Results: The bench test showed perfect coverage of the bifurcation with minimal stent's struts overlap at the proximal part of SB ostium and a small, single layer stent struts, neo-carina not affecting the MV patency. Seventy-three complex patients (67% of Medina 1,1,1 lesions; 44% of unprotected distal left main lesions) were treated with sirolimus-, paclitaxel-, or zotarolimus-eluting stents using the TAP technique. Procedural success was achieved in all cases and the clinical outcome up to 9 month was characterized by a low rate of clinically-driven target vessel revascularization (6.8%)., Conclusions: The TAP-stenting is a modification of the T-stenting technique which allows full coverage of bifurcated lesions and facilitates final kissing balloon. The first clinical experience suggests that this technique may be practical, thus calling for further evaluations of the technique., ((c) 2007 Wiley-Liss, Inc.)

Background: Stent thrombosis (ST) is a recognized complication limiting the clinical efficacy of percutaneous coronary interventions (PCI). Because of the increasing number of stent-based PCI, the absolute number of patients experiencing ST is expected to expand. Re-PCI is the commonly adopted treatment for patients with ST; however, the prognostic variables as well as the angiographic and clinical results have not been systematically assessed. Moreover, the possible benefit associated with the use of adjunctive devices (AD) with theoretical antiembolic property has not been systematically analyzed in this high-risk population., Methods: We present the design of a prospective and retrospective multicenter registry to assess the contemporary angiographic and clinical outcome of PCI in patients with ST. Moreover, we sought to assess if the use of thrombectomy or distal protection AD is associated with any improvement in the PCI's angiographic results. All patients with angiographically confirmed ST undergoing attempt of PCI in the enrolling centers during a fixed 2-year study period will enter the study. Clinical outcome during hospitalization, at 30 days and 6 months will be assessed. Percutaneous coronary intervention with or without AD will be performed according to physician's discretion. All PCI cine-film will undergo blind core laboratory analysis to assess a series of key angiographic data (TIMI flow, TIMI frame count, thrombus score, myocardial blush grade, distal embolization)., Conclusions: The OPTIMIST study is designed to provide a detailed description of the angiographic and clinical outcome achieved in the real world with contemporary PCI for ST. Moreover, it will provide observational data regarding the role of AD in this high-risk scenario.