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Background: Intravascular lithotripsy (IVL) showed to be effective in dilating heavily calcified de novo coronary lesions but little is known about its performance in under-expanded stents management. Aim of this study was to assess the feasibility, effectiveness and safety of IVL for the treatment of stent underexpansion refractory to balloon dilatation. Methods: A multicentre, retrospective cohort analysis was performed in patients undergoing IVL to treat under-expanded stents following non-compliant balloon expansion failure. Primary endpoint was successful IVL dilatation defined as IVL balloon delivery and application at the target site followed by an increase of at least 1 mm2 in minimal stent cross-sectional area (MSA) on intracoronary imaging or an increase of at least 20% in minimal stent diameter (MSD) by quantitative coronary analysis (QCA). Results: Thirty-nine under-expanded stents (34 patients) were included. Two cases (5.1%) of multiple stent layers and one (2.5%) acutely under-expanded stent were treated. The median IVL balloon diameter was 3.1 mm (IQR: 2.5–3.5 mm) while the number of pulses emitted was 56.7 (IQR: 30–80). IVL was successful in 34 cases (87.1%), with significant improvement in MSD (post: 3.23 mm [IQR: 3–3.5 mm] vs. pre: 0.81 mm [IQR: 0.35–1.2], p < 0.00001) and MSA (post: 7.61mm2 [IQR: 6.43–7.79mm2] vs. pre: 3.35 [IQR: 2.8–4 mm2], p < 0.00001). Non-fatal peri-procedural ST-elevation myocardial infarction occurred in one case (2.5%) due to IVL balloon rupture. No cardiac death, target lesion revascularization and stent thrombosis occurred in-hospital and at 30-day follow-up. Conclusions: Bailout IVL was feasible, efficacious and safe to improve refractory stent under-expansion.

It is debated whether percutaneous revascularization (PCI) of total coronary chronic occlusion (CTO) is superior to optimal medical therapy (OMT) in improving symptoms, left ventricular (LV) function and major adverse cardiac/cerebrovascular events (MACCE). Furthermore, CTO-PCI is a challenging technique, with lower success rate than in other settings. A systematic analysis of baseline LV function, infarction extent and ischaemic burden to predict response to revascularization has never been performed.To establish a CMR protocol to identify patients (pts) who can benefit most from CTO-PCI. Myocardial viability/ischaemia retains high biological plausibility as predictors of response to revascularization. Therefore, baseline viability (necrotic tissue extent, response to inotropic stimulation) and ischaemia (perfusion defect, wall motion abnormality during stress) will be studied as potential predictors of mechanical LV segmental improvement and ischaemic burden reduction in CTO territory (primary endpoint), LV remodelling and global function, Seattle Angina Questionnaire, and MACCE improvement (secondary endpoints) in the follow-up.Pts with CTO suitable for PCI undergo stress-CMR for viability/ischaemia assessment. Pts with normal LV function undergo adenosine, those with moderately-reduced ejection fraction (EF) and wall motion abnormalities high-dose dobutamine, pts with EF35% low-dose dobutamine. All pts undergo late gadolinium enhancement and repeat the same scan at 12 ± 3 months, regardless of PCI success or decision for OMT.A multi-parameter CMR protocol tailored on pts characteristics to study viability/ischaemia could help in identifying responders in terms of LV function, ischaemic burden and clinical outcome among pts suitable for CTO-PCI, improving selection of best candidates to percutaneous revascularization.

Coronary artery aneurysm is defined as a coronary dilation that exceeds the diameter of adjacent segments or the diameter of the patient's largest normal coronary vessel by 1.5×. It is an uncommon disease that has been diagnosed with increasing frequency since the widespread appearance of coronary angiography. The published incidence varies from 1.5% to 5%, suggesting male dominance and a predilection for the right coronary artery. Although several causes have been described, atherosclerosis accounts for ≥50% of coronary aneurysms in adults. Reported complications include thrombosis and distal embolization, rupture, and vasospasm, causing ischemia, heart failure, or arrhythmias. The natural history and prognosis remain unknown, as definitive data are scarce. Controversies persist regarding the use of medical management (antithrombotic therapy) or interventional/surgical procedures. Only some case reports or small case series are available about this condition. The Coronary Artery Aneurysm Registry (CAAR; http://www.ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02563626","term_id":"NCT02563626"}}NCT02563626) is a multicenter international ambispective registry that aims to provide insights on anatomic, epidemiologic, and clinical aspects of this substantially unknown entity. In addition, the registry will assess management strategies (conservative, interventional, or surgical) and their short‐ and long‐term results in a large cohort of patients. Clinical Trial registration: ClinicalTrials.gov. Unique identifier: {"type":"clinical-trial","attrs":{"text":"NCT02563626","term_id":"NCT02563626"}}NCT02563626.

To assess the incidence of no-reflow in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI), analyze possible causes and differential diagnoses, and identify useful management approaches.In this multicenter observational study, all CTO-PCIs performed between January 2018 and April 2019 were reviewed to collect no-reflow complications, defined as Thrombolysis in Myocardial Infarction (TIMI) flow ≤1 in a patent epicardial artery. Patient clinical, anatomical, and procedural characteristics were analyzed.Out of 461 PCIs, two (0.43%) were complicated by no-reflow. In 1 case, PCI was performed on a long segment of the right coronary artery, after use of a dissection-re-entry technique by knuckle wiring. In the second patient, no-reflow developed after proximal left anterior descending coronary artery stenting, with a short subintimal tracking. Intravascular ultrasound was used to exclude complications in the epicardial vessel in both cases. Distal embolization seems the most plausible cause, and intracoronary adenosine effectively improved flow. Both patients had a type 4a myocardial infarction, asymptomatic in the first case, and associated with chest pain, electrocardiographic changes, and new regional wall-motion abnormality at echocardiography in the second case.No-reflow in CTO recanalization is rare, but associated with a high risk of periprocedural myocardial infarction, with incomplete protection from ischemia offered by the pre-existing collateral network.

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

Background Coronary Aneurysms are a focal dilatation of an artery segment >1.5-fold the normal size of adjacent segments. Although some series have suggested a prevalence of 0.3–12%, data are lacking. In addition, they are not mentioned in practice guidelines. Our aim was investigate its prevalence, management and long-term outcomes. Methods and results The coronary artery aneurysm registry (CAAR) involved 32 hospitals across 9 countries in America and Europe. We reviewed 436,467 consecutive angiograms performed over the period 2004–2016. Finally, 1565 patients were recruited. Aneurysm global prevalence was 0.35%. Most patients were male (78.5%) with a mean age of 65 years and frequent cardiovascular risk factors. The main indication for angiogram was an acute coronary syndrome, 966 cases. The number of aneurisms was ≤2 per patient in 95.8% of the cases, mostly saccular, most frequently found in the left anterior descending and with numbers proportional with coronary stenosis. Aortopathies were related with more aneurysms too. Most patients received any revascularization procedure (69%), commonly percutaneous (53%). After a median follow-up of 37.2 months, 485 suffered a combined event (MACE) and 240 died. Without major differences comparing CABG vs PCI, MACE and death were more frequent in patients who received bare metal stents. Conclusions Coronary artery aneurysms are not uncommon. Usually, they are associated with coronary stenosis and high cardiovascular risk. Antiplatelet therapy seems reasonable and a percutaneous approach is safe and effective.

Background Coronary Aneurysms are a focal dilatation of an artery segment of >1.5-fold the normal size of adjacent segments. Some limited series suggested an incidence of 0.3–12%. However, coronary aneurysms are not mentioned in practice guidelines and several questions remain unanswered. Purpose To investigate its clinical profile, prognostic predictors, and long term outcomes. Methods The coronary artery aneurysm registry (CAAR, NCT02563626) is a collaborative effort involving 32 hospitals across 9 countries (Canada, Cuba, Czech Republic, Germany, Italy, Netherlands, Spain, USA and Uruguay). When eligibility was uncertain, cases were reviewed by a core lab. Results We reviewed 436,467 consecutive angiographies between 2004–2016. 1,565 patients were ambispectively included. Global incidence was 0.35%. Most were male (78.5%) with a mean age of 65 years. Cardiovascular risk factors were frequent. An aortopathy history was present in 8.7% but a Kawasaki antecedent was unfrequent (0.3%). The main indication for cath was an ACS in 966 cases. Most aneurysms were saccular and 82 giant. The number of aneurisms was low, mainly with 1–2 (95.8%) and only 3 patients with ≥6, proportionally with more coronary stenosis. The most affected artery was the LAD. Aortopathy was related with higher number of aneurysms. Most received any revascularization, commonly percutaneous (PCI). During a follow-up of 37.2 months, 485 suffered a MACE, (death/heart failure/unstable angina/reinfarction) and 240 died. Age, race, diabetes, renal failure, peripheral disease, acute cath, coronary stenosis, LVEF and anticoagulation remained as predictors of death/MACE after multivariate adjustments, without no major differences comparing CABG vs PCI. No restenosis was found in aneurysm with DES but those with BMS suffered 4 (p=0.002). MACE and death were more frequent in patients who received BMS. Figure 1 Conclusions Coronary aneurysmal disease is not uncommon. It is associated with severe coronary stenosis and a high cardiovascular risk burden, pointing out an aggressive atherosclerotic status. Antiplatelet therapy is a reasonable option and interventional procedures safe and effective, compared with surgery. Drug eluting stents should be preferred as the default strategy. Acknowledgement/Funding None

Background: Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure. Aim: To evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD). Methods: XLIMIT is a multicenter randomized controlled trial targeting 180 patients requiring percutaneous coronary interventions (PCI). Patients will be treated with Xlimus SES or Synergy EES implantation and randomization will be performed in a 2:1 ratio. The primary endpoint will be the reendothelialization grade of the Xlimus stent in terms of strut coverage and neointimal hyperplasia volume as compared to Synergy. Secondary endpoints will be represented by clinical and procedural outcomes. The first patient was enrolled on February 2019. Conclusions: A clearer understanding of the endothelialization process of new generation DES could significantly impact the treatment with dual antiplatelet therapy in the future. Moreover, although not powered for clinical end-points, the XLIMIT trial will provide randomized data in a population with minimal exclusion criteria. Trial registration: ClinicalTrials.gov Identifier: NCT03745053. Registered on November 19, 2018. Keywords: Clinical trials, Drug-eluting stent, Coronary artery disease

The introduction into clinical practice of transcatheter aortic valve implantation (TAVI) has led to a significant change in the therapeutic paradigm for patients with valvular aortic stenosis. However, in parallel with the benefits obtained in prognosis and quality of life, an inherent risk of major cerebral thromboembolic events has been observed. In different studies this risk has been estimated between 2% and 6%. In order to reduce the incidence of cerebrovascular accidents during TAVI, several brain protection systems have been developed but, to date, none has obtained sufficient clinical evidence to be implemented on a large scale, and they are therefore used only in selected cases. Furthermore, periprocedural drug therapy and follow-up are still the subject of extensive discussion in the scientific community. This paper reviews the topic of stroke prevention in patients undergoing TAVI for both the periprocedural and postprocedural aspects.

Background Previous trials comparing carotid artery stenting (CAS) with carotid endarterectomy have shown that the former can increase the stroke rate. However, in the last years, because of the improvements either of the technique or the improvement of the stents and embolic protection devices (EPD), CAS has become a very competitive procedure. In this study, we tried to assess the feasibility and the safety of using double EPD (proximal and distal) in high-risk patients. Methods We collected data about all consecutive patients with carotid artery stenosis who underwent CAS and compared clinical and procedural characteristics as well as immediate and 30-day outcomes between the use of double vs. single EPD. Results Between November 2007 and August 2014, 294 patients underwent CAS. In 35 of them (11.9%) double EPD was used. In comparison with the patients treated with single EPD, those with double EPD presented more with acute carotid syndrome (recurrent TIAs

Increasing evidence suggests that percutaneous coronary intervention with newer generation drug-eluting stents may be an acceptable alternative, or even preferred in selected cases to the surgical approach, in patients with left main disease. This review will discuss the anatomic factors, the clinical variables, and the procedural strategies to consider, including physiology assessment and imaging guidance, in order to optimize outcomes.

Background The optimal treatment of unprotected left main (UPLM) with either PCI or CABG remains uncertain. Aim The purpose of this study was to determine the comparative safety and efficacy of PCI versus CABG in patients with UPLM disease. Methods Search of BioMedCentral, CENTRAL, mRCT, PubMed, major cardiological congresses proceedings and references cross-check (updated November 2016). Outcomes were the rate of MACE [all cause death, MI, stroke], the rates of the individual components of MACE and the rate of target vessel revascularisation (TVR). Results We identified 6 Randomised Controlled Trials totalling 4717 patients allocated to PCI or CABG. At 1 year follow up, PCI and CABG were substantially equivalent with respect to the rates of MACE [PCI 8.5% vs CABG 8.9%, OR 1.02,(0.76–1.36), p = 0.9], death [PCI 5.4% vs CABG 6.6%, OR 0.81,(0.63–1.03),p = 0.08] and MI [PCI 3.4% vs CABG 4.3%, OR 0.80 (0.59–1.07), p = 0.14]. Notably, PCI was associated with a significantly lower rate of stroke [PCI 0.6% vs CABG 1.8%, OR 0.36,(0.17–0.79), p = 0.01] and with a significantly higher rate of TVR [PCI 8.7% vs CABG 4.5%, OR 2.00(1.46–2.75), p

Patient Initials or Identifier Number LMR ### Relevant Clinical History and Physical Exam 49 years, female cardiovascular risk factors: former smoker comorbidities: multifactorial anemia 2014: NSTEMI → PCI +DES in obtuse marginal 2017: aspecific thoracic pain → coronary CT scan →

Background The feasibility and efficacy of percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) via transradial access (TRA) is still a matter of concern, mainly in an unselected population. Methods We collected data about all PCI performed in patients with ULMCA stenosis by a TRA-dedicated operator and analyzed clinical and procedural characteristics as well as in-hospital and long-term outcomes. Results From January 2008 to December 2011, 49 PCIs were performed; 27 (55%) via TRA and 22 (45%) via transfemoral access (TFA). Most patients in both groups underwent PCI for acute coronary syndrome (66.7% in the TRA group vs 77.3% in the TFA group, p = 0.73). Patients in the TRA group were more hypertensive (81.5% vs 40.9%, p = 0.008) and had a higher left ventricular ejection fraction (54.6 ± 10.3 vs 46.1 ± 12.8, p = 0.01). There were no significant differences in procedural success (100% in the TRA group vs 90.9% in the TFA group, p = 0.38), as well as in procedural time, in fluoroscopic time and in contrast volume. Bleeding complications occurred in 1 patient in the TFA group (4.5%) vs none in the TRA group (p = 0.91). In-hospital major adverse cardiac events (MACE) occurred in 1 patient (3.7%) in the TRA group vs 3 (13.6%) in the TFA group (p = 0.48). At a follow-up of 32 ± 13 months, MACE occurred in 4 cases (14.8%) in the TRA group vs 7 cases (31.8%) in the TFA group (p = 0.28). Conclusions The PCI of ULMCA via TRA is feasible with good results, provided that a rigorous learning curve was followed and a TRA volume caseload was maintained.

Coronary artery aneurysm is defined as a coronary dilation that exceeds the diameter of adjacent segments or the diameter of the patient's largest normal coronary vessel by 1.5×. It is an uncommon disease that has been diagnosed with increasing frequency since the widespread appearance of coronary angiography. The published incidence varies from 1.5% to 5%, suggesting male dominance and a predilection for the right coronary artery. Although several causes have been described, atherosclerosis accounts for ≥50% of coronary aneurysms in adults. Reported complications include thrombosis and distal embolization, rupture, and vasospasm, causing ischemia, heart failure, or arrhythmias. The natural history and prognosis remain unknown, as definitive data are scarce. Controversies persist regarding the use of medical management (antithrombotic therapy) or interventional/surgical procedures. Only some case reports or small case series are available about this condition. The Coronary Artery Aneurysm Registry (CAAR; http://www.ClinicalTrials.gov NCT02563626) is a multicenter international ambispective registry that aims to provide insights on anatomic, epidemiologic, and clinical aspects of this substantially unknown entity. In addition, the registry will assess management strategies (conservative, interventional, or surgical) and their short‐ and long‐term results in a large cohort of patients. Clinical Trial registration: ClinicalTrials.gov. Unique identifier: NCT02563626.

Aims: Randomized clinical trials (RCTs) are the most reliable evidence, even if they require important resource and logistic efforts. Large, cost-free and real-world datasets may be easily accessed yielding to observational studies, but such analyses often lead to problematic results in the absence of careful methods, especially from a statistic point of view. We aimed to appraise the performance of current multivariable approaches in the estimation of causal treatment and effects in studies focusing on drug-eluting stents (DES). Methods and Results: Pertinent studies published in the literature were searched, selected, abstracted, and appraised for quality and validity features. Six studies with a logistic regression were included, all of them reporting more than 10 events for covariates and different length of follow-up, with an overall low risk of bias. Most of the 15 studies with a Cox proportional hazard analysis had a different follow-up, with less than 10 events for covariates, yielding an overall low or moderate risk of bias. Sixteen studies with propensity score were included: the most frequent method for variable selection was logistic regression, with underlying differences in follow-up and less than 10 events for covariate in most of them. Most frequently, calibration appraisal was not reported in the studies, on the contrary of discrimination appraisal, which was more frequently performed. In seventeen studies with propensity and matching, the latter was most commonly performed with a nearest neighbor-matching algorithm yet without appraisal in most of the studies of calibration or discrimination. Balance was evaluated in 46% of the studies, being obtained for all variables in 48% of them. Conclusions: Better exploitation and methodological appraisal of multivariable analysis is needed to improve the clinical and research impact and reliability of nonrandomized studies. (J Interven Cardiol 2012;25:611–621)

Functional assessment of coronary lesions has become an integral part of routine practice in most cath labs. Such evaluation is performed using a pressure wire that allows measurement of fractional flow reserve (FFR). The latter has received a class I indication with level of evidence A according to the most recent European guidelines on myocardial revascularization for the assessment of angiographically moderate coronary lesions. The present document has the following objectives: 1) to summarize the theoretical basis of FFR; 2) to provide a guideline for vasodilator therapy; 3) to summarize scientific evidence supporting FFR; 4) to provide a model of health economy evaluation focusing on resource sparing associated with the use of FFR.

ObjectivesTo first explore in Italy appropriateness of indication, adherence to guideline recommendations and mode of selection for coronary revascularisation.DesignRetrospective, pilot study.Setting22 percutaneous coronary intervention (PCI)-performing hospitals (20 patients per site), 13 (59%) with on-site cardiac surgery.Participants440 patients who received PCI for stable coronary artery disease (CAD) or non-ST elevation acute coronary syndrome were independently selected in a 4:1 ratio with half diabetics.Primary and secondary outcome measuresProportion of patients who received appropriate PCI using validated appropriate use scores (ie, AUS≥7). Also, in patients with stable CAD, we examined adherence to the following European Society of Cardiology recommendations: (A) per cent of patients with complex coronary anatomy treated after heart team discussion; (B) per cent of fractional flow reserve-guided PCI for borderline stenoses in patients without documented ischaemia; (C) per cent of patients receiving guideline-directed medical therapy at the time of PCI as well as use of provocative test of ischaemia according to pretest probability (PTP) of CAD.ResultsOf the 401 mappable PCIs (91%), 38.7% (95% CI 33.9 to 43.6) were classified as appropriate, 47.6% (95% CI 42.7 to 52.6) as uncertain and 13.7% (95% CI 10.5% to 17.5%) as inappropriate. Median PTP in patients with stable CAD without known coronary anatomy was 69% (78% intermediate PTP, 22% high PTP). Ischaemia testing use was similar (p=0.71) in patients with intermediate (n=140, 63%) and with high PTP (n=40, 66%). In patients with stable CAD (n=352) guideline adherence to the three recommendations explored was: (A) 11%; (B) 25%; (C) 23%. AUS was higher in patients evaluated by the heart team as compared with patients who were not (7 (6.8) vs 5 (4.7); p=0.001).ConclusionsUse of heart team approaches and adherence to guideline recommendations on coronary revascularisation in a real-world setting is limited. This pilot study documents the feasibility of measuring appropriateness and guideline adherence in clinical practice and identifies substantial opportunities for quality improvement.Trial registration numberNCT02748603.

Previous trials comparing carotid artery stenting (CAS) with carotid endarterectomy have shown that the former can increase the stroke rate. However, in the last years, because of the improvements either of the technique or the improvement of the stents and embolic protection devices (EPD), CAS has become a very competitive procedure. In this study, we tried to assess the feasibility and the safety of using double EPD (proximal and distal) in high-risk patients.We collected data about all consecutive patients with carotid artery stenosis who underwent CAS and compared clinical and procedural characteristics as well as immediate and 30-day outcomes between the use of double vs. single EPD.Between November 2007 and August 2014, 294 patients underwent CAS. In 35 of them (11.9%) double EPD was used. In comparison with the patients treated with single EPD, those with double EPD presented more with acute carotid syndrome (recurrent TIAs48 hr, minor stroke14 days) and with complex plaque (79.4 vs. 33.6%, P0.0001). There was no difference between the 2 groups in primary success (100 vs. 99.6%, P = 0.16) and in 30-days major complications: death (0 vs. 0.8%, P = 0.6), major stroke (0 vs. 0.8%, P = 0.42), and minor stroke (0 vs 1.1%, P = 0.66).In our experience, in high-risk patients with high-risk lesions, the use of double EPD (proximal and distal) is safe and effective in minimizing the risk of cerebral embolization, but, to validate such a technique in wide range of patients, further studies are warranted.

To assess the impact on in-hospital and long-term survival of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS).From September 2001 to May 2010 we collected data from 155 patients affected with STEMI complicated by CS undergoing PPCI (12.4% of all PPCI) including 70 patients (45.2%) in TA group and 85 patients (54.8%) in conventional PCI group. Patients in TA group were more likely to have right ventricular infarction (24.3% vs 5.9%, p=0.002), higher mean left ventricular ejection fraction (40% ± 9% vs 35% ± 7%, p0.0001) and lower left main coronary artery occlusion (2.8% vs 21.2%, p=0.002). TA was associated with a lower rate of in-hospital and long-term mortality (31.4% vs 48.2%, p=0.05 and 42.8% vs 64.7%, p=0.01 respectively) at a mean follow-up time of 6.1 ± 2.1 years. At multivariate analysis the only independent predictor of in-hospital and long-term survival was the procedural success (HR 0.18 95% CI 0.025-0.31, p=0.03 and HR 0.46 95% CI 0.09-0.74, p=0.034 respectively).In this retrospective study TA, performed during PPCI for STEMI complicated by CS, was not an independent predictor of in-hospital and long-term survival.

Background Developed countries are facing a sustained increase in life expectancy. Along with all social and cultural implications of increase lifespan, very elderly patients are undergoing percutaneous coronary intervention (PCI) with increasing frequency. However, there is limited evidence to guide clinicians in evaluating pros and cons of PCI in this very frail patient population. We, thus, aimed to perform a systematic review and meta-analysis of clinical studies reporting on PCI with stenting in nonagenarians. Methods Studies reporting on five or more nonagenarians undergoing PCI were systematically searched in PubMed (last updated on November 2011). Baseline and clinical characteristics, in-hospital and long-term outcomes were systematically appraised. End points of interest were in-hospital and long-term follow-up incidence of death and Major Adverse Cardiac Events (MACE; i.e. the composite of death from all causes, myocardial infarction or repeat revascularization). Events were pooled with a random-effect model, generating summary estimates of incidence rates [95% confidence intervals (CI)]. Results A total of 10 studies were included, reporting on a total of 575 nonagenarians undergoing PCI with stenting who represented 1.99% (1.34-2.5) of those undergoing revascularization in the cath lab in a mean period of 5 (3-7) years. Twenty-three percent (13-45) of patients presented with STEMI (ST Segment Elevation Myocardial Infarction), 10% (7-12) with cardiogenic shock and in 78% (64-88) of cases a multivessel disease was diagnosed. Meta-analytic pooling of event rates showed an in-hospital death risk of 12.61% (9.71-15.50) with MACE in 16.41% (13.36-19.47). After a follow-up ranging from 6 to 29 months (median 12), the risk of long-term death was 31.00% (17.10-45.52), with MACE in 37.00% (19.56-55.95; all CI 95%). Conclusion Our meta-analysis, pooling the largest cohort ever of nonagenarians undergoing PCI with stents, confirms the feasibility of percutaneous coronary stenting even in this very frail patient subset, despite the expected severe event attrition during follow-up. Thus, nonagenarians with an acceptable risk profile, recent clinical instability and/or disabling symptoms should not be denied the possibility of percutaneous coronary revascularization.

Background Stent thrombosis remains among the most feared complications of percutaneous coronary intervention (PCI) with stenting. However, data on its incidence and predictors are sparse and conflicting. We thus aimed to perform a collaborative systematic review on incidence and predictors of stent thrombosis. Methods PubMed was systematically searched for eligible studies from the drug-eluting stent (DES) era (1/2002–12/2010). Studies were selected if including ≥2000 patients undergoing stenting or reporting on ≥25 thromboses. Study features, patient characteristics, and incidence of stent thrombosis were abstracted and pooled, when appropriate, with random-effect methods (point estimate [95% confidence intervals]), and consistency of predictors was formally appraised. Results A total of 30 studies were identified (221,066 patients, 4276 thromboses), with DES used in 87%. After a median of 22months, definite, probable, or possible stent thrombosis had occurred in 2.4% (2.0%; 2.9%), with acute in 0.4% (0.2%; 0.6%), subacute in 1.1% (1.0%; 1.3%), late in 0.5% (0.4%; 0.6%), and very late in 0.6% (0.4%; 0.8%). Similar figures were computed for studies reporting only on DES. From a total of 47 candidate variables, definite/probable stent thrombosis was more commonly and consistently predicted by early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length, with acute coronary syndrome at admission, diabetes, smoking status, and bifurcation/ostial disease also proving frequent predictors, but less consistently. Conclusions Despite numerous possible risk factors, the most common and consistent predictors of stent thrombosis are early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length.

Chronic kidney disease (CKD) constitutes a predictor of adverse events for surgical aortic valve replacement. In patients undergoing TAVI no study was performed to evaluate outcomes according to renal clearance, which represents the most accurate instrument to assess kidney function.From January 2007 to December 2011 all TAVI patients of our institutions were prospectively divided into 3 cohorts. Preserved renal function those with clearance more or equal to 60 ml/min/1.73 m2, moderate CKD those between 30 and 60, and severe CKD those between 15 and 30. Patients with a clearance less than 15 or in dialysis were excluded. All outcomes were adjudicated according to VARC criterion.72 patients with preserved renal function, 219 with moderate and 73 with severe CKD were included; those in the latter group were older and with lower ejection fraction. At 30 days, severe CKD was associated with a trend toward a higher risk of major events than preserved and moderate CKD: cardiovascular death (2.8% vs 6.7% vs 9%; p=0.256) life threatening bleedings (10% vs 10% vs 16%; p=0.384), major stroke (1.4% vs 2.3% vs 4.1%; p=0.763). At a medium follow-up of 540 ± 250 days, cardiovascular death incidence was higher in patients with severe CKD (7% vs 8 vs 19%; p0.0001), however this difference was not consistently significant after multivariable adjustment (p=0.300). Overall, 2% of patients developed kidney failure, whereas 47.1% of patients with severe CKD improved to moderate renal impairment.Patients with severe chronic renal disease presented higher risk of adverse events, mainly driven by increased hazard of bleedings. TAVI procedures could offer kidney functional improvement in an important subset of patients.

The aim of this study was to evaluate short- and long-term results of PCI (percutaneous coronary intervention) in patients with small vessel coronary artery disease and the prognostic impact of the extension and the length of coronary lesions.All consecutive patients treated with PCI in our centre between July 2002 and December 2004 were included and divided into two groups according to the diameter of the implanted stents: small vessel disease was defined as requiring implantation of stents2.75 mm in diameter. The primary end point was the long-term incidence of major adverse cardiac events (MACE), the composite of cardiac mortality, nonfatal myocardial reinfarction, and repeated percutaneous target vessel revascularization (re-PTCA TVR). 1599 patients were treated by PCI: 419 (26.2%) were implanted with 2.75 mm or smaller stents. At both 1 and 36 months as well as at 53 + 20 months of follow-up small vessel stenting was associated with a higher rate of MACE (4.2% vs 2.1%, P= 0.028; 20.3% vs 17.9%, P0.001; 27.5% vs 22.4%, P= 0.04, respectively). Multivariate analysis showed higher rates of revascularization for patients with small vessel disease regardless of lesion length. Rates of death were higher in patients with small vessels and long lesions.Atherosclerotic involvement of small vessels in patients with CAD confers a higher short- and long-term risk of adverse outcome after PCI.

OBJECTIVES To investigate the relationship between classic SYNTAX and functional SYNTAX score guided by fractional flow reserve (FFR). BACKGROUND SYNTAX score predicts clinical outcome after percutaneous coronary intervention in patients with multivessel coronary artery disease (CAD), based on data from angiography alone. However, in the clinical setting, decision-making on myocardial revascularization should be guided by reliable demonstration of inducible ischemia, as detected by FFR. METHODS FFR was collected in all 50-90% angiographic stenoses of 39 consecutive patients with stable multivessel CAD. SYNTAX score was calculated as usually described in SYNTAX group's reports. A functional SYNTAX (F-SYNTAX) score was determined by only considering ischemia-producing lesions (FFR ≤ 0.80). The two scores were compared with correlation, Bland-Altman and agreement tests. RESULTS FFR was measured in 97 lesions, with a median value of 0.82±0.10. In the 50-70% and 70-90% category stenoses, FFR was greater than 0.80 in 68 and 16% of cases, respectively. F-SYNTAX was systematically inferior to SYNTAX score, with a median difference of 8.4±7.4 (P

Aims Highly active antiretroviral therapy (HAART) dramatically reduces human immunodeficiency virus (HIV)-associated morbidity and mortality, but adverse effects of HAART are becoming an increasing challenge, especially in the setting of acute coronary syndromes (ACS). We thus performed a comprehensive review of studies focusing on ACS in HIV patients. Methods and results MEDLINE/PubMed was systematically screened for studies reporting on ACS in HIV patients. Baseline, treatment, and outcome data were appraised and pooled with random-effect methods computing summary estimates [95% confidence intervals (CIs)]. A total of 11 studies including 2442 patients were identified, with a notably low prevalence of diabetes [10.86 (4.11, 17.60); 95% CI]. Rates of in-hospital death were 8.00% (2.8, 12.5; 95% CI), ascribable to cardiovascular events for 7.90% (2.43, 13.37; 95% CI), with 2.31% (0.60, 4.01; 95% CI) developing cardiogenic shock. At a median follow-up of 25.50 months (11.25, 42; 95% CI), no deaths were recorded, with an incidence of 9.42% of acute myocardial infarction (2.68, 16.17; 95% CI) and of 20.18% (9.84, 30.51; 95% CI) of percutaneous coronary revascularization. Moreover, pooled analysis of the studies reporting incidence of acute myocardial infarction in patients exposed to protease inhibitors showed an overall significant risk of 2.68 (odds ratio 1.89, 3.89; 95% CI). Conclusion Human immunodeficiency virus patients admitted for ACS face a substantial short-term risk of death and a significant long-term risk of coronary revascularization and myocardial infarction, especially if receiving protease inhibitors.

Background Acute coronary syndromes (ACS) represent a difficult challenge for physicians. Risk scores have become the cornerstone in clinical and interventional decision making. Methods and results PubMed was systematically searched for ACS risk score studies. They were divided into ACS studies (evaluating Unstable Angina; UA, Non ST Segment Elevation Myocardial Infarction; NSTEMI, and ST Segment Elevation Myocardial Infarction; STEMI), UA/NSTEMI studies or STEMI studies. The c-statistics of validation studies were pooled when appropriate with random-effect methods. 7 derivation studies with 25,525 ACS patients and 15 validation studies including 257,654 people were formally appraised. Pooled analysis of GRACE scores, both at short (0.82; 0.80–0.89 I.C 95%) and long term follow up (0.84; 0.82–0.87; I.C 95%) showed the best performance, with similar results to Simple Risk Index (SRI) derivation cohorts at short term. For NSTEMI/UA, 18 derivation studies with 56,560 patients and 18 validation cohorts with 56,673 patients were included. Pooled analysis of validations studies showed c-statistics of 0.54 (95% CI = 0.52–0.57) and 0.67 (95% CI = 0.62–0.71) for short and long term TIMI validation studies, and 0.83 (95% CI = 0.79–9.87) and 0.80 (95% CI = 0.74–0.89) for short and long term GRACE studies. For STEMI, 15 studies with 134,557 patients with derivation scores, and 17 validation studies with 187,619 patients showed a pooled c-statistic of 0.77 (95% CI = 0.71–0.83) and 0.77 (95% CI = 0.72–0.85) for TIMI at short and long term, and a pooled c-statistic of 0.82 (95% CI = 0.81–0.83) and 0.81 (95% CI = 0.80–0.82) for GRACE at short and long terms respectively. Conclusions TIMI and GRACE are the risk scores that up until now have been most extensively investigated, with GRACE performing better. There are other potentially useful ACS risk scores available however these have not undergone rigorous validation. This study suggests that these other scores may be potentially useful and should be further researched.

A 29-year-old woman with two mechanical valve prostheses was referred to our institution for sudden and self-resolved diplopia 2 weeks after childbirth. From the beginning of pregnancy, nadroparin was started instead of warfarin. The echocardiogram performed at hospital admission revealed a severe aortic prosthesis regurgitation due to incomplete leaflet apposition with a prosthetic aortic transvalvular gradient increase. Three-dimensional transoesophageal echocardiography revealed a thrombus located between the two prostheses, causing intermittent aortic valve malfunction. Intravenous heparin was started. Three days later, a second transoesophageal echocardiogram revealed a decreased aortic transvalvular gradient, but an oval thrombus adhered to the mitral prosthesis and fluctuating through the prosthetic valve was detected. Tissue plasminogen activator infusion was started. To reduce cerebral embolization, carotid filters used during artery angioplasty were placed in common carotid arteries, left and right. No complication occurred during and after the procedure. With thrombus absence at 30-min transoesophageal echocardiography, filters were removed. The patient continued intravenous heparin until achievement of a therapeutic international normalized ratio range and she was asymptomatic on discharge.

Antiplatelet therapy plays a fundamental role in reducing atherothrombotic events by several pathways. The present work reviews available evidence on antiplatelet therapy both for primary prevention and in the presence of established peripheral, cerebral, or cardiac ischemic disease. Due to the importance of adherence to therapy to achieve optimal effects, special attention is given to the use of fixed-dose oral formulations in the clinical subset of patients in whom double antiplatelet therapy has proven indications.

To the editorTakotsubo cardiomyopathy (TCM), first described by Japanese physicians in the 1990s,1 normally occurs following stressful situations or events.2,3 Although the specific cause of TCM is still debated, several factors have been proposed, such as coronary artery spasm,4 microvascular invol

We aimed to appraise the early and long-term outcome after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in patients with unprotected left main disease (ULM) and left ventricular systolic dysfunction (LVD).PCI with DES has being performed with increasing frequency in subjects with ULM and LVD, but few specific data are available.We identified patients undergoing PCI with DES for ULM at our Center and distinguished those with ejection fraction (EF)50% from those with 40%EFor=50% and those with EFor=40%. The primary end-point was the rate of major adverse cerebro-cardiovascular events (MACCE, ie death, myocardial infarction [MI], stroke, repeat PCI or bypass surgery).A total of 197 patients were included, 57.4% with EF50%, 32.0% with 40%EFor=50%, and 10.6% with EFor=40%. In-hospital mortality was significantly higher in those with EFor=40% (9.5% vs. 0 and 3.2%, P0.001). A total of 96% patients were followed for 23 +/- 14 months, yielding a MACCE rate of 44.2% (41.6% in those with EF50%, 41.6% in those with 40%EFor=50%, and 61.9% in those with EFor=40%, P = 0.4). Specifically, death occurred in 2.7%, 7.9%, and 28.6% (P0.001), cardiac death in 1.8%, 4.8%, and 23.8% (P = 0.001), MI in 8.0%, 7.9% and 0 (P = 0.4), and TVR in 15.9%, 11.1% and 33.3% (P = 0.6).Systolic ventricular dysfunction is highly correlated with in-hospital and long term death rates in patients undergoing PCI with DES for ULM disease. However it does not confer an increased risk of nonfatal adverse events or stent thrombosis.

Background: The optimal stenting strategy for coronary bifurcation lesions has not yet been defined, especially given the lack of very long-term data (>24 months). We compared our long-term results of a simple vs complex stenting strategy in patients with bifurcation lesions. Methods: We retrospectively selected subjects undergoing percutaneous coronary intervention (PCI) with stenting in a bifurcation lesion between June 2002 and December 2005, comparing those treated with a simple technique vs those treated with a complex one. The primary end-point was the rate of major adverse cardiac events (MACE) at >24 months of follow-up. Results: A total of 326 patients were included, 64.7% treated with a simple technique (Group A) and 35.3% with a complex strategy (Group B). Drug-eluting stents were used in 82.0% and 73.0%, respectively (P = 0.059), final kissing balloon in 47.9% and 53.0% (P = 0.37), and procedural success obtained in 99.5% and 99.1% (P = 0.66). After a median of 34 months, MACE occurred in 52 (26.5%) in Group A and in 32 (31.4%) in Group B (P = 0.37), cardiac death in six (3.1%) vs four (3.9%, P = 0.70), myocardial infarction in 13 (6.6%) vs 6 (5.9%, P = 0.80), target vessel revascularization in 36 (18.4%) vs 29 (28.4%, P = 0.04), and bypass in five (2.6%) vs two (2%, P = 0.74). Definite stent thrombosis was adjudicated in two (1%) vs one (0.9%, P = 0.98). Conclusions: This study, comparing simple and complex stenting strategies for the treatment of coronary bifurcation lesions, shows that both techniques are associated with favorable clinical results and low adverse events rates at long-term follow-up. © 2009 Wiley-Liss, Inc.

Percutaneous aortic valve replacement is performed with increasing frequency in patients with severe aortic stenosis at prohibitive surgical risk. Currently available devices are however in their early development stage, and are thus quite bulky with a large profile, with ensuing difficulties in delivery of the device through a stenotic aortic valve. We report hereby a case in which we employed a buddy wire and balloon technique as a "shoehorn" to enable accurate delivery of a balloon-expandable aortic valve prosthesis from the transfemoral route.

Objectives: We aimed to conduct a retrospective cohort study focusing on our 5-year experience in the percutaneous treatment of unprotected left main (ULM) trifurcation disease. Background: Percutaneous treatment of ULM trifurcation remains a challenging and rare procedure for most interventional cardiologists. Moreover, data on long-term outcomes are lacking. Methods: We retrieved all patients with ULM trifurcation disease treated percutaneously at our Institution since 2002, and adjudicated baseline, procedural, and outcome data. The primary end point was the long-term rate of major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, bypass surgery, or target vessel revascularization). Results: A total of 27 patients underwent percutaneous coronary intervention with stent implantation for ULM trifurcation disease, with 14 (52%) cases of true trifurcations, i.e., with concomitant significant stenoses of the distal ULM/ostial left anterior descending plus ostial ramus intermedius and ostial circumflex. Bare-metal stents were implanted in 8 (29%) patients and drug-eluting stents (DES) in 26 (96%), with a main branch stent only strategy in 11 (40%), T stenting in 9 (33%), and V stenting in 6 (27%). Procedural and clinical success occurred in 26 (96%), with one postprocedural death. Angiographic follow-up was obtained in 22 patients (81%), and clinical follow-up was completed in all subjects after a median of 28 ± 17 months, showing overall MACE in 9 (33%), with cardiac death in 4 (15%), myocardial infarction in 1 (4%), coronary artery bypass grafting (CABG) in 4 (15%), and percutaneous target vessel revascularization in 5 (19%). Definite stent thrombosis was adjudicated in 1 (3%) patient. Treatment of a true trifurcation lesion and recurrence of angina during follow-up were significantly associated with an increased risk of MACE (P = 0.029 and P = 0.050, respectively). Conclusions: Percutaneous treatment of ULM trifurcation disease is feasible, associated with favorable mid-term results, and may be considered given its low invasiveness in patients at high surgical risk or with multiple comorbidities. © 2008 Wiley-Liss, Inc.

Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES), such as sirolimus-eluting (Cypher®) and paclitaxel-eluting stents (Taxus®), have further improved results of percutaneous coronary intervention (PCI) by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor®) and everolimus-eluting stents (Xience V®), have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent.

Given their suboptimal success rates, coronary chronic total occlusions (CTO) represent one of the last challenges of percutaneous coronary intervention (PCI). Among several novel techniques, the retrograde approach is one of the most promising, but it is still incompletely described. We report our 5-year experience in retrograde PCI for CTOs. We abstracted patient and procedural data on all cases with attempted retrograde approach. End-points were technical and procedural success, plus long-term major adverse cardiovascular events (MACE). The retrograde approach was used in 17 patients, with procedural success in 12 (71%), including 9 CTOs of right coronary, 2 of left circumflex, and 2 of left main arteries. Conversely, 4 cases of technical failure and 1 post-procedural myocardial infarction in an otherwise angiographically successful procedure were found. Causes of retrograde failure were: inability to deliver the balloon through the chosen collateral in 2 cases, inability to retrogradely cross the distal stump with the wire in 1 case, and interruption of the procedure due to rupture of a minor septal collateral branch during attempts at advancing the non-inflated balloon in 1 case. In all patients with retrograde failure, subsequent antegrade attempts could be carried out, with ultimate success in everybody. Follow-up at 24±21 months showed an overall MACE rate of 23%. In conclusion, the retrograde approach appears feasible and safe, and its application can be envisioned as a promising alternative strategy in selected patients in whom antegrade approaches fail or are deemed unsafe.