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Cerebrovascular accidents (CVAs) can complicate the follow-up of patients with acute myocardial infarction (AMI). Intracavitary blood stasis evaluation can be useful to stratify cardioembolic risk and optimize medical therapy. Cardiac magnetic resonance (CMR) imaging is increasingly used in AMI patients for prognostic purposes. Slow-flow artefact is common on T2-weighted images in presence of left ventricular (LV) blood stasis.In this observational retrospective study, all patients with AMI undergoing CMR in our hospital were included. T2-weighted images were used to assess the presence of LV blood stasis. Among the 209 patients enrolled (males 72%, mean age 61 ± 12 years), LV blood stasis was detected in 48 (23%) and was significantly more prevalent in patients with extensive anterior or antero-apical AMI, lower LV ejection fraction, greater infarct size and microvascular obstruction. During follow-up (54 months, IQR 41-70), 8 CVAs and 6 cardiovascular deaths occurred. LV blood stasis emerged as a significant risk factor for both endpoints (logRank p 0.001 and p = 0.008, respectively) and remained independent predictor of CVAs (HR 9.819, 95% CI 1.733-55.617, p = 0.010).LV blood stasis identified with CMR predicts the occurrence of CVAs in patients with AMI. These results may be helpful to personalize antithrombotic therapy for prevention strategies.

Introduction Refractory angina (RA) is considered the end-stage of coronary artery disease, and often has no interventional treatment options. Coronary sinus Reducer (CSR) is a recent addition to the therapeutic arsenal, but its efficacy has only been evaluated on small populations. The RESOURCE registry provides further insights into this therapy. Methods The RESOURCE is an observational, retrospective registry that includes 658 patients with RA from 20 centers in Europe, United Kingdom and Israel. Prespecified endpoints were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score, the rates of procedural success and complications, and MACEs as composite of all-cause mortality, acute coronary syndromes, and stroke. Results At a median follow-up of 502 days (IQR 225–1091) after CSR implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. Procedural success was achieved in 96.7% of attempts, with 3% of procedures aborted mostly for unsuitable coronary sinus anatomy. Any complication occurred in 5.7% of procedures, but never required bailout surgery nor resulted in intra- or periprocedural death or myocardial infarction. One patient developed periprocedural stroke after inadvertent carotid artery puncture. At the last available follow-up, overall mortality and MACE were 10.4% and 14.6% respectively. At one, three and five years, mortality rate at Kaplan-Meier analysis was 4%, 13.7%, and 23.4% respectively. Conclusions CSR implantation is safe and reduces angina in patients with refractory angina.

The coronary sinus (CS) Reducer is a novel device designed for the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization. Aim of this study was to investigate the efficacy and the safety of the CS Reducer device in a real-world, multicenter, and country-level cohort of patients presenting with refractory angina pectoris. The study included patients affected by refractory angina pectoris who underwent CS Reducer implantation in 16 centers. Clinical follow-up was carried as per each center's protocol. One hundred eighty-seven patients were included. Technical and procedural success were achieved in 98% and 95%, respectively. Minor peri-procedural complications were recorded in 8 patients. During a median follow-up of 18.4 months, 135 (82.8%) patients demonstrated at least 1 CCS class reduction after Reducer implantation, and 80 (49%) patients at least 2 CCS class reduction. Mean CCS class improved from 3.05 ± 0.53 at baseline to 1.63 ± 0.98 at follow-up (p < 0.001). Treatment benefit was also reflected in a significant improvement in quality of life scores and in a reduction of the mean number of anti-ischemic drugs prescribed for patient. In conclusion, in this multicenter, country-level study, the implantation of CS Reducer in patients with refractory angina pectoris resulted to be safe and effective in reducing of angina pectoris and improving quality of life.

Objectives This study aimed to investigate the feasibility and safety of left atrial appendage occlusion (LAAO) procedures in patients with persistent left atrial appendage (LAA) thrombus. Background The left atrial appendage (LAA) is the most common site of thrombus formation in patients with nonvalvular atrial fibrillation (AF). Oral anticoagulation (OAC) is used to prevent and treat AF-related thrombus. However, a significant proportion of patients may not be eligible for long-term OAC therapy. In many cases, OAC may fail to resolve the thrombus. Left atrial appendage occlusion (LAAO) may be a potential option in such cases. Major LAAO studies have excluded patients with LAA thrombus, and it is not known whether LAAO procedures in the presence of LAA thrombus is feasible and safe. Methods This was a systematic review of patient-level data of all published cases of LAAO in the presence of LAA thrombus. Results There was a total of 58 patients included in the study. Most of the patients had a distally located thrombus in the LAA. All cases underwent successful implantation of LAAO devices with some procedural modifications. Amulet was the most commonly used device (50%). A cerebral protection device was used in 17 (29%) patients, and procedural transesophageal echocardiography was used in most of the cases. One stroke (1.7%) and 2 (3.4%) device-related thromboses were noted during the mean follow-up of 3.4 ± 7 months. Conclusions Percutaneous LAAO procedures appear to be feasible in patients with a distally located persistent LAA thrombus when performed by experienced operators with some technical modifications. Further studies are required to determine the long-term safety and efficacy of this approach.

Primary ventricular fibrillation (PVF) may occur in the early phase of ST-elevation myocardial infarction (STEMI) prior to primary percutaneous coronary intervention (PCI). Multiple electrocardiographic STEMI patterns are associated with PVF and short-term mortality including the tombstone, Lambda, and triangular QRS-ST-T waveform (TW). We aimed to compare the predictive value of different electrocardiographic STEMI patterns for PVF and 30-day mortality. We included a consecutive cohort of 407 STEMI patients (75% males, median age 66 years) presenting within 12 h of symptoms onset. At first medical contact, 14 (3%) showed the TW or Lambda ECG patterns, which were combined in a single group (TW-Lambda pattern) characterized by giant R-wave and downsloping ST-segment. PVF prior to primary PCI occurred in 39 (10%) patients, significantly more often in patients with the TW-Lambda pattern than those without (50% vs. 8%, p < 0.001). For the multivariable analysis, Killip class ≥3 (OR 6.19, 95% CI 2.37–16.1, p < 0.001) and TW-Lambda pattern (OR 9.64, 95% CI 2.99–31.0, p < 0.001) remained as independent predictors of PVF. Thirty-day mortality was also higher in patients with the TW-Lambda pattern than in those without (43% vs. 6%, p < 0.001). However, only LVEF (OR 0.86, 95% CI 0.82–0.90, p < 0.001) and PVF (OR 4.61, 95% CI 1.49–14.3, p = 0.042) remained independent predictors of mortality. A mediation analysis showed that the effect of TW-Lambda pattern on mortality was mediated mainly via the reduced LVEF. In conclusion, among patients presenting with STEMI, the electrocardiographic TW-Lambda pattern was associated with both PVF before PCI and 30-day mortality. Therefore, this ECG pattern may be useful for early risk stratification of STEMI.

Coronary sinus Reducer is a current therapeutic treatment for patients with persistent refractory angina. We report a case of successful implantation of the device in the middle cardiac vein of a 65 years old female patient. The singular and unusual site for the Reducer was planned after a careful assessment of the venous drainage of the ischemic territory.

Aims After percutaneous coronary intervention (PCI) with second-generation drug-eluting stent (DES), whether short dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) with a P2Y12 receptor inhibitor confers benefits compared with prolonged DAPT is unclear. Methods and results Multiple electronic databases, including PubMed, Scopus, Web of Sciences, Ovid, and ScienceDirect, were searched to identify randomized clinical trials comparing ≤3 months of DAPT followed by P2Y12 inhibitor SAPT vs. 12 months of DAPT after PCI with second-generation DES implantation. The primary and co-primary outcomes of interest were major bleeding and stent thrombosis 1 year after randomization. Summary hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by fixed-effect and random-effects models. Multiple sensitivity analyses including random-effects models 95% CI adjustment were applied. A sensitivity analysis comparing trials using P2Y12 inhibitor SAPT with those using aspirin SAPT was performed. A total of five randomized clinical trials (32 145 patients) were available. Major bleeding was significantly lower in the patients assigned to short DAPT followed by P2Y12 inhibitor SAPT compared with those assigned to 12-month DAPT (random-effects model: HR 0.63, 95% 0.45–0.86). No significant differences between groups were observed in terms of stent thrombosis (random-effects model: HR 1.19, 95% CI 0.86–1.65) and the secondary endpoints of all-cause death (random-effects model: HR 0.85, 95% CI 0.70–1.03), myocardial infarction (random-effects model: HR 1.05, 95% CI 0.89–1.23), and stroke (random-effects model: HR 1.08, 95% CI 0.68–1.74). Sensitivity analyses showed overall consistent results. By comparing trials testing ≤3 months of DAPT followed by P2Y12 inhibitor SAPT vs. 12 months of DAPT with trials testing ≤3 months of DAPT followed by aspirin SAPT vs. 12-month of DAPT, there was no treatment-by-subgroup interaction for each endpoint. By combining all these trials, regardless of the type of SAPT, short DAPT was associated with lower major bleeding (random-effects model: HR 0.63, 95% CI 0.48–0.83) and no differences in stent thrombosis, all-cause death, myocardial infarction, and stroke were observed between regimens. Conclusion After second-generation DES implantation, 1–3 months of DAPT followed by P2Y12 inhibitor SAPT is associated with lower major bleeding and similar stent thrombosis, all-cause death, myocardial infarction, and stroke compared with prolonged DAPT. Whether P2Y12 inhibitor SAPT is preferable to aspirin SAPT needs further investigation.

Bioresorbable scaffolds have emerged as a potential breakthrough for the treatment of coronary artery lesions. The need for drug release and plaque scaffolding is temporary, and leaving a permanent stent once the process of plaque recoil and vessel healing has ended might be superfluous or even deleterious exposing the patient to the risk of very late thrombosis, eliminating vessel reactivity, impairing non-invasive imaging and precluding possible future surgical revascularization. This long-term potential limitation of permanent bare metal stents might be overcome by using a resorbable scaffold. The metallic and antithrombotic properties make the resorbable magnesium scaffold an appealing technology for the treatment of coronary artery lesions. Notwithstanding this, its mechanical properties substantially differ from those of conventional bare metal stents, and previous experience using polymer-based scaffolds has shown that a standardized implantation technique and optimal patient and lesion selection are key factors for a successful implantation. A panel of expert cardiologists gathered to find a consensus on the best practices for Magmaris implantation in a selected patient population and to discuss the rationale for new potential future indications.

BACKGROUND In last few decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice. OBJECTIVE This study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing treatment for aortic stenosis with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The study also aims to evaluate the feasibility of wearable devices in assessing physical function in such patients. METHODS This is a prospective observational study. The enrollment will be conducted 1 month before patients’ SAVR/TAVR. Patients will be provided with the wearable device at baseline (activity tracker device, Garmin vívoactive 3). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12 months after SAVR/TAVR. After baseline assessment, they will undergo 4 follow-up assessments at 1, 3, 6, and 12 months after SAVR/TAVR. At baseline and each follow-up, they will undergo a set of standard and validated tests to assess physical function, health-related quality of life, and sleep quality. RESULTS The ethics committee of Vicenza in Veneto Region in Italy approved the study (Protocol No. 943; January 4, 2019). As of October 2020, the enrollment of participants is ongoing. CONCLUSIONS The use of the wearable devices for real-time monitoring of physical activity of patients undergoing aortic valve replacement is a promising opportunity for improving the clinical management and consequently, the health outcomes of such patients. CLINICALTRIAL Clinicaltrials.gov NCT03843320; https://tinyurl.com/yyareu5y INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20072

AIMS: The coronary sinus Reducer is a percutaneous device proven to improve angina symptoms in refractory angina (RA). We evaluated its potential cost-effectiveness and impact on the healthcare resource use. METHODS AND RESULTS: Angina-related healthcare resource usage and quality-of-life data were collected for 215 consecutive RA patients undergoing Reducer implantation in Belgium, the Netherlands, and Italy. Costs were assessed from each country's healthcare system perspective. Data from the date of RA diagnosis to Reducer implantation [Standard-of-Care (SoC)-period] and from Reducer implantation to follow-up (Reducer-period) were compared: during Reducer-period, a significant reduction in angina-driven hospitalizations, outpatient visits, coronary angiograms, and percutaneous coronary interventions per patient-year was observed, translating into significantly reduced costs per patient-year. To assess cost-effectiveness, costs and utilities of 1-year SoC were compared with those of 1-year Reducer-period. Assumptions on Reducer efficacy duration were further explored with modelled projections. Reducer was associated with higher quality-adjusted life years (QALYs: 0.665 vs. 0.580, P

Patent foramen ovale (PFO) is implicated in the pathogenesis of different clinical syndromes in which it plays variable roles. In 2017 and 2018, four randomized clinical trials were published, allowing for the clarification of certain issues pertaining to cryptogenic stroke. Recently, eight European scientific societies collaborated to the writing of an interdisciplinary international position paper on PFO and cryptogenic stroke, based upon best available evidence, with the aim of defining the principles needed to guide decision making. Nonetheless, a tailored approach is not suitably addressed by standard position documents, considering that decisions about optimal management of PFO patients with left circulation thromboembolism are often challenging, mostly due to comorbidities and complex clinical scenarios.A panel of Italian cardiology experts gathered under the auspices of the Italian Society of Interventional Cardiology (SICI-GISE) for comprehensive discussion and consensus development, with the aim of providing practical recommendations, for both clinical and interventional cardiologists, regarding optimal management of PFO in patients with cerebral or systemic thromboembolism. In this position paper, various clinical scenarios in patients with and without high-risk PFO features are presented and discussed, including PFO patients with associated conditions (e.g. hypercoagulable states, deep vein thrombosis/pulmonary embolism, short runs of atrial fibrillation), and special subsets (e.g. patients with risk factors for atrial fibrillation, patients aged ≥65 years, patients who refused percutaneous PFO closure), with the Panel's recommendations being provided for each scenario.

Background In last few decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice. Objective This study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing treatment for aortic stenosis with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The study also aims to evaluate the feasibility of wearable devices in assessing physical function in such patients. Methods This is a prospective observational study. The enrollment will be conducted 1 month before patients’ SAVR/TAVR. Patients will be provided with the wearable device at baseline (activity tracker device, Garmin vívoactive 3). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12 months after SAVR/TAVR. After baseline assessment, they will undergo 4 follow-up assessments at 1, 3, 6, and 12 months after SAVR/TAVR. At baseline and each follow-up, they will undergo a set of standard and validated tests to assess physical function, health-related quality of life, and sleep quality. Results The ethics committee of Vicenza in Veneto Region in Italy approved the study (Protocol No. 943; January 4, 2019). As of October 2020, the enrollment of participants is ongoing. Conclusions The use of the wearable devices for real-time monitoring of physical activity of patients undergoing aortic valve replacement is a promising opportunity for improving the clinical management and consequently, the health outcomes of such patients. Trial Registration Clinicaltrials.gov NCT03843320; https://tinyurl.com/yyareu5y International Registered Report Identifier (IRRID) DERR1-10.2196/20072

This study aimed to investigate the feasibility and safety of left atrial appendage occlusion (LAAO) procedures in patients with persistent left atrial appendage (LAA) thrombus.The left atrial appendage (LAA) is the most common site of thrombus formation in patients with nonvalvular atrial fibrillation (AF). Oral anticoagulation (OAC) is used to prevent and treat AF-related thrombus. However, a significant proportion of patients may not be eligible for long-term OAC therapy. In many cases, OAC may fail to resolve the thrombus. Left atrial appendage occlusion (LAAO) may be a potential option in such cases. Major LAAO studies have excluded patients with LAA thrombus, and it is not known whether LAAO procedures in the presence of LAA thrombus is feasible and safe.This was a systematic review of patient-level data of all published cases of LAAO in the presence of LAA thrombus.There was a total of 58 patients included in the study. Most of the patients had a distally located thrombus in the LAA. All cases underwent successful implantation of LAAO devices with some procedural modifications. Amulet was the most commonly used device (50%). A cerebral protection device was used in 17 (29%) patients, and procedural transesophageal echocardiography was used in most of the cases. One stroke (1.7%) and 2 (3.4%) device-related thromboses were noted during the mean follow-up of 3.4 ± 7 months.Percutaneous LAAO procedures appear to be feasible in patients with a distally located persistent LAA thrombus when performed by experienced operators with some technical modifications. Further studies are required to determine the long-term safety and efficacy of this approach.

Transcatheter aortic valve replacement (TAVR) has been recognized as a well-established alternative to surgical aortic valve replacement (SAVR) for symptomatic aortic stenosis with high surgical risk. With this updated systematic review and meta-analysis, we evaluated TAVR vs. SAVR in low- and intermediate-risk subjects. Studies comparing TAVR and SAVR in low-risk patients (defined as STS ≤ 8% or EuroSCORE ≤ 20%) were identified with electronic searches. The principal endpoint was all-cause mortality at short term (

Objectives This study sought to evaluate the feasibility, safety, and efficacy of intracardiac echocardiography (ICE)–guided versus transesophageal echocardiography (TEE)–guided left atrial appendage occlusion (LAAO) by the use of Amplatzer Cardiac Plug or Amulet devices included in a large Italian registry. Background TEE is widely used for LAAO procedure guidance. ICE may be a potential alternative imaging modality in LAAO. Methods Data from 604 LAAO procedures performed in 16 Italian centers were reviewed. ICE-guided LAAO was performed in 187 patients, whereas TEE was used in 417 patients. Procedural success was defined as LAAO without occurrence of pericardial tamponade, stroke, systemic embolism with end organ damage, major bleeding, and device embolization. Stroke, transient ischemic attack, major bleeding, overall and cardiovascular death were analyzed. Results CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65 to 74 years, sex category) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores were similar between the ICE and TEE groups. TEE implied lower procedural (delta 12 min) and fluoroscopy time (delta 5 min) when compared with ICE. Procedural success was similarly high (≥94%) between the TEE and ICE groups with a complication rate of 6.5% for TEE versus 4.2% for ICE (odds ratio: 1.468; 95% confidence interval: 0.681 to 3.166; p = 0.327). At median follow-up of 451 days (interquartile range: 162 to 899 days), the rate of cerebral ischemic events was similar between TEE-guided and ICE-guided procedures. Conclusions ICE-guided LAAO by means of Amplatzer devices may represent a second alternative imaging modality after an appropriate learning curve and bearing in mind that pre-procedural computed tomography imaging is mandatory. When comparing ICE with TEE, TEE remains the gold standard.

Background: Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic performance of the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, California, USA) transcatheter heart valves (THV) are limited. Therefore, this study aimed to compare long-term clinical outcome data and hemodynamic performance of TAVR with either CV or ES. Methods: We reviewed prospectively collected data of 171 patients treated with TAVR for severe aortic stenosis (AS) at our center between June 2007 and December 2010, with last follow-up contact in 2016. Results: Out of 171 patients treated with TAVR at our Institution, 87 received a CV and 84 an ES THV. Mean age was 81 [78–85] years, and mean Society of Thoracic Surgeons (STS) score was 7.5% [4.5–13.9%]. Hemodynamic success by Valve Academic Research Consortium (VARC) definition was 97.1%. Mean trans-prosthetic gradient remained low and stable during follow-up in both groups (at 5-year 9.2±6.4 versus 12.7±5.1 mmHg, P=0.10). Late prosthesis failure occurred in 4 cases (2.4%). Thirty-day mortality was 4.7%, and estimated survival rates by Kaplan-Meyer after 1, 5 and 8 years were 87.6%, 44.9%, and 24.5%, respectively, without difference between THV groups. Rates of cardiovascular death, stroke, myocardial infarction (MI) and congestive heart failure (CHF) were also similar with CV and ES at long-term follow-up. History of CHF, pre-existent severe mitral regurgitation, paravalvular leak grade ≥2+, and chronic obstructive pulmonary disease were independent predictors of late mortality at multivariate analysis. Conclusions: Clinical and hemodynamic outcomes of patients treated by self-expandable CV or balloon-expandable ES THV were favorable and similar throughout long-term follow-up, with a rate of prosthesis failure of less than 3%.

We thank Dr. Tamis-Holland and colleagues for their interest in our article [(1)][1]. We recognize that combining prospective observational studies with randomized controlled trials (RCTs) might be a limitation, but this was done to increase the statistical power of our observations. We acknowledge

BACKGROUND Peripheral arterial disease (PAD) plays a decisive role in the preinterventional selection process of the optimal vascular access site in patients undergoing transcatheter aortic valve implantation (TAVI). However, the impact of PAD on mortality and vascular complications (VCs) in TAVI-treated patients remains unclear. Accordingly, we aimed to assess the outcomes of patients with and without PAD undergoing TAVI, by performing a meta-regression analysis. METHODS Studies published between January 2002 and March 2018 and reporting outcomes according to the presence of PAD in TAVI patients were identified. Outcome measures analyzed were short-, mid- and long-term mortality, and peri-procedural VC. The interaction between sheath size and PAD on outcomes was also assessed. RESULTS A total of 26 studies (68,581 TAVI patients, of whom 17,326 with preprocedural PAD) were included in the analysis. Patients with PAD had higher risk of mortality at short- (HR 1.36, 95% confidence interval [CI] 1.13-1.63, p = .0009), mid- (HR 1.18, 95% CI 1.08-1.30, p = .0005), and long-term (HR 1.36, 95% CI 1.24-1.48, p

Percutaneous mitral valve repair (MVR) using MitraClip system has been shown to be effective in patients with severe symptomatic mitral regurgitation deemed at high surgical risk. Atrial fibrillation is frequently observed in this setting, and the presence of a contraindication to oral anticoagulation is also very common in these patients. In this context, percutaneous left atrial appendage occlusion (LAAO) may be a valid alternative in reducing the thromboembolic risk. Since there is a large overlap between these two populations and the two procedures share some common steps, a combined approach of percutaneous MVR using the MitraClip system and LAAO may be considered a suitable strategy for patients with serious contraindications to both cardiac surgery and chronic antithrombotic therapy. Here we report the case of a patient affected by severe functional mitral regurgitation, secondary to post-infarction ventricular dilation, symptomatic for heart failure despite optimal medical therapy and cardiac resynchronization, and by atrial fibrillation with a contraindication for systemic anticoagulation due to high bleeding risk. Therefore, it was decided to perform a combined transcatheter procedure of MVR and LAAO.

Objectives The authors conducted a systematic pairwise and network meta-analysis to assess optimal treatment strategies in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MV-CAD) undergoing primary percutaneous coronary intervention (PCI). Background Patients with STEMI and MV-CAD have a worse prognosis than those with single-vessel CAD. The optimal revascularization strategy for these patients is uncertain. Methods Studies of revascularization strategies for MV-CAD in STEMI patients undergoing primary PCI published between 2001 and 2015 were identified using an electronic search. Pairwise and network meta-analyses were performed for 3 PCI strategies in prospective and retrospective studies: 1) infarct-related artery (IRA)-only PCI; 2) single procedure MV-PCI; and 3) staged MV-PCI. Information on study design, inclusion and exclusion criteria, and clinical outcomes was extracted. The outcomes of interest were short-term and long-term mortality. Results Thirty-two studies (13 prospective and 19 retrospective) with 54,148 patients (IRA-only PCI [n = 42,112], single procedure MV-PCI [n = 8,138], and staged MV-PCI [n = 3,898]) were included in the analysis. Pairwise meta-analyses showed that staged MV-PCI was associated with lower short-term and long-term mortality compared with both IRA-only PCI and single stage MV-PCI, whereas IRA-only PCI was associated with lower mortality compared with single stage MV-PCI. Staged MV-PCI was also associated consistently with improved survival in network analyses. Conclusions The present systematic review and meta-analysis supports the hypothesis that in patients with MV-CAD presenting with STEMI undergoing primary PCI, a staged multivessel revascularization strategy may improve early and late survival.

Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASD) is the gold-standard treatment, because of a comparable efficacy and less complications than heart surgery. Nevertheless, percutaneous treatment of very large ASD is still considered a challenging procedure and is discouraged for diameters larger than 38 mm, especially when atrial septal rims are absent. These patients are characterized by more frequent complications when a percutaneous approach is attempted. Hence, the treatment of choice is still debated. We report the case of a 75-year-old Caucasian male, admitted for congestive heart failure secondary to a very large ASD. After accurate sizing with transesophageal echocardiography and sizing balloon, percutaneous closure with an Amplatzer Septal Occluder was successfully performed, using few simple tricks.

Acute ST-segment elevation myocardial infarction (STEMI) typically arises from total occlusion of an epicardial coronary artery, most often due to atherosclerotic plaque rupture/erosion and subsequent thrombus formation. Granted this, important angiographic information for patients presenting with STEMI is not only about the status of infarct-related artery (IRA) but also about the atherosclerotic disease burden and disease severity of non-IRA vessels. Previous studies have reported that multivessel coronary artery disease is found in approximately 50% of patients with STEMI undergoing primary percutaneous coronary intervention (PCI). Primary PCI is now considered the gold standard in the treatment for patients with STEMI; however, the optimal reperfusion strategy in patients with STEMI and multivessel disease (MVD) remains uncertain. In this review, we summarize the available evidence on treatment options for patients with STEMI and MVD and highlight current guideline recommendations on this topic.

This study sought to evaluate the feasibility, safety, and efficacy of intracardiac echocardiography (ICE)-guided versus transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) by the use of Amplatzer Cardiac Plug or Amulet devices included in a large Italian registry.TEE is widely used for LAAO procedure guidance. ICE may be a potential alternative imaging modality in LAAO.Data from 604 LAAO procedures performed in 16 Italian centers were reviewed. ICE-guided LAAO was performed in 187 patients, whereas TEE was used in 417 patients. Procedural success was defined as LAAO without occurrence of pericardial tamponade, stroke, systemic embolism with end organ damage, major bleeding, and device embolization. Stroke, transient ischemic attack, major bleeding, overall and cardiovascular death were analyzed.CHAICE-guided LAAO by means of Amplatzer devices may represent a second alternative imaging modality after an appropriate learning curve and bearing in mind that pre-procedural computed tomography imaging is mandatory. When comparing ICE with TEE, TEE remains the gold standard.

The appropriate use of dual antiplatelet therapy (DAPT) in elderly patients with acute coronary syndrome (ACS) remains a highly debated subject. In fact, achieving the correct balance between the reduction of ischemic risk and the increase in hemorrhagic events is more difficult in this population than in younger subjects, especially in the case of very potent drug therapy. As a consequence of this, despite guideline recommendations, antiplatelet therapy is currently underutilized in elderly patients with ACS.In current clinical practice, the antiplatelet drugs that can be used in combination with aspirin are clopidogrel, prasugrel and ticagrelor. The efficacy of these molecules is supported by randomized clinical trials, which gave variable results in terms of the extent of reduction in ischemic events and increase in hemorrhagic complications. The purpose of this article is to identify, based on the results of a consensus meeting, common elements in the use of DAPT in the elderly and to identify areas where further scientific evidence is required to better define the role of the individual antiplatelet agents.

Aims The aim of this study was to investigate the feasibility, safety and efficacy of percutaneous closure for prevention of thromboembolic events in patients with atrial fibrillation (AF) and left atrial appendage (LAA) thrombus. Methods and results The study included consecutive patients with AF and LAA thrombus who underwent transcatheter occlusion in eight high-volume centres. Clinical and transoesophageal echocardiography (TEE) follow-up was carried out as per each centre's protocol. Twenty-eight patients were included. The location of the LAA thrombus was distal in 100% of cases. Technical and procedural success was achieved in all patients. A cerebral protection device was used in six cases. There were no periprocedural adverse events. Follow-up was complete in all patients (total 32 patient-years). No death or thromboembolic events were reported. There was one major bleeding during follow-up. Among the 23 patients undergoing TEE, device thrombosis was present in one patient. No significant peri-device leaks were observed. Conclusions In this multicentre study, percutaneous closure in selected patients with distal LAA thrombus appears to be feasible and safe, and is associated with high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Special implant techniques avoiding mechanical mobilisation of the thrombotic mass and the liberal use of cerebral embolic protection devices are recommended.

Background: Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER (TM) devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding.Methods: From December 2008 to April 2015 613 NVAF patients (75.1 +/- 8.0 years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER (TM) devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset.Results: AMPLATZER (TM) devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20 months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6 months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively.Conclusions: In this large, multicenter, single-nation study, LAAO with the AMPLATZER (TM) devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism. (C) 2017 Elsevier B.V. All rights reserved.

Conflicting data have been reported related to the impact of atrial fibrillation (AF) on the outcomes after transcatheter aortic valve implantation (TAVI). We aimed to assess the prognosis of TAVI-treated patients according to the presence of pre-existing or new-onset AF.Studies published between April 2002 and November 2016 and reporting outcomes of pre-existing AF, new-onset AF, or sinus rhythm in patients undergoing TAVI were identified with an electronic search. Pairwise and network meta-analysis were performed. Outcomes of interest were short- and long-term mortality, stroke, and major bleeding.Eleven studies (11,033 individuals) were eligible. Compared to sinus rhythm, short-term and long-term mortality were significantly higher in new-onset AF (short-term OR 2.9, P=.002; long-term OR 2.3, P.0001) and pre-existing AF groups (short-term OR 2.7, P=.004; long-term OR 2.8, P.0001). Compared to sinus rhythm, new-onset AF increased the risk of stroke at early (OR 2.1, P.0001) and late follow-up (OR 1.92, P.0001), and the risk of early bleedings (OR 1.65, P=.002), while pre-existing AF increased the risk of late stroke (OR 1.3, P=0.03), but not the risk of bleeding. Compared to pre-existing AF, new-onset AF correlated with higher risk of early stroke (OR 1.7, P=.002) and major bleedings (OR 1.7, P=.002).AF is associated with impaired outcomes after TAVI, including mortality, stroke and (limited to new-onset AF) major bleedings. Compared to pre-existing AF, new-onset AF correlates with higher risk of early stroke and major bleedings. Improved management of AF in the TAVI setting, including tailored antithrombotic treatment strategies, remains a relevant need.

Background A specific ECG pattern of presentation of ST-segment elevation acute myocardial infarction (STEMI), characterized by “triangular QRS-ST-T waveform” (TW), has been associated with poor in-hospital prognosis but longitudinal data on its incidence and clinical impact are lacking. We prospectively evaluated the incidence and prognostic meaning of the TW pattern in a cohort of consecutive STEMI patients. Methods All STEMI patients who presented within 12 h of symptoms onset and showed no complete bundle branch block or paced ventricular rhythm were included. The TW pattern was defined as a unique, giant wave (amplitude ≥ 1 mV) resulting from the fusion of the QRS complex, the ST-segment and the T-wave and showing a “triangular” morphology with a positive polarity in the leads exploring the ischemic region. Results Among 428 consecutive STEMI patients, 367 fulfilled the enrollment criteria. The TW pattern was identified in 5 of 367 patients (1.4%) on the admission ECG. This subset of STEMI patients with TW pattern significantly more often showed a left main coronary artery involvement (2/4, 50% vs 2/322, 0.6%; p Conclusions The TW pattern is an uncommon ECG finding, which reflects the presence of a large area of transmural myocardial ischemia and predicts cardiogenic shock accounting for high in-hospital mortality. When present, this ECG pattern should prompt aggressive therapeutic strategies, including mechanical support of circulation.

Large thrombus burden (LTB) lesions in the context of primary percutaneous coronary intervention (p-PCI) have been related to unsuccessful angiographic reperfusion and unfavorable clinical outcomes. However, the hazard of LTB treatment on myocardial damage has not been evaluated. We investigated the impact of LTB on myocardial damage using contrast-enhanced cardiac magnetic resonance (CE-CMR) in the setting of p-PCI. In 327 patients, who underwent p-PCI without thrombus aspiration within 12 hours from symptom onset, we prospectively assessed the impact of LTB on infarct size and microvascular damage using CE-CMR. LTB was defined by the presence of Thrombolysis In Myocardial Infarction thrombus score ≥3 in patent infarct-related artery (IRA); or by "cut-off" occlusion pattern and/or large reference vessel diameter (≥3.5 mm) in occluded IRA. One hundred ninety-seven patients (60.2%) showed LTB and 130 (39.8%) did not. Distal embolization occurred in 18.8% patients with versus 6.9% without LTB (p = 0.003). At CE-CMR, patients with LTB had larger infarct size index (27.5 ± 11.1 vs 22.1 ± 17.5, p = 0.009) and more often transmural necrosis (70.5% vs 55.4%, p = 0.008) compared with patients without LTB. Excluding patients with distal embolization, patients with LTB still had larger necrosis. At multivariate analysis, occluded (IRA) at baseline, anterior infarction, and presence of LTB predicted transmural necrosis. In conclusion, LTB in the setting of p-PCI is related to larger myocardial damage as detected by CE-CMR, regardless of angiographic detectable distal embolization.

Coronary bifurcation lesions represent a difficult problem regularly confronting interventional cardiologist, in part due to the lack of dedicated device.To investigate the feasibility, safety and effectiveness of the Tryton Side Branch Stent (Tryton Medical, Durham, NC, USA), a dedicated bare metal stent deployed in conjunction with a standard drug-eluting stent to treat bifurcation lesions.The SAFE-TRY is a prospective single arm multicenter registry including patients with de novo bifurcation lesions in native coronary arteries and syntax score32. The primary endpoint was target vessel failure (TVF) at 30 days that comprised cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization. Secondary endpoints included device, angiographic and procedural success, 9-month major adverse cardiac and cerebrovascular event (MACCE), and stent thrombosis (ST) rates (ClinicalTrials.gov identifier: NCT01174433).Among 252 enrolled patients, 24% had diabetes and 35.3% unstable angina. True bifurcation lesions involving both branches occurred in 96.8% of cases with Medina classification 1.1.1 in 62%. The left anterior descending artery and the left main were treated in 70% and 8.3% of the patients, respectively. A 6 Fr guide catheter was used in 61% of the cases. Device, angiographic and procedural success rates were 99.6%, 99.6% and 97.2% respectively. The 30-day TVF was 2.8%; the 9-month MACCE rate was 13.7%, with target lesion revascularization being 4.4%. No definite ST occurred.This prospective, multicenter study confirmed the feasibility, safety and effectiveness of the Tryton Side Branch Stent to treat patients with de novo complex bifurcation lesions.

Background Gender-based differences in diabetic patients are understudied in the field of percutaneous coronary intervention (PCI) with drug-eluting stents. Methods Data were obtained from a multicenter registry of 2420 consecutive patients with diabetes mellitus (DM) who underwent PCI with paclitaxel- or sirolimus-eluting stents between 2003 and 2009. Among them, 679 (28.1%) women were compared to 1741 (71.9%) men in terms of clinical aspects and major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR). Target vessel revascularization (TVR) and any revascularization were also reported. Results Women were less numerous, older, used more insulin and showed more tortuous coronary arteries, while men were more frequently smokers and received larger stents. At the median follow-up of 24.3months (interquartile range 12.3–39.7), MACE, TVR and any revascularization did not significantly differ between females and males (19.9% vs 18.7%, 12.2% vs 13.4%, 14.1% vs 15.1%, respectively). At multivariable analysis of the overall cohort, female gender was not a predictor of MACE (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.92–2.36, p=0.11), death (HR 1.04, 95% CI 0.84–1.24, p=0.86), MI (HR 1.48, 95% CI 0.92–2.36, p=0.11), and TLR (HR 1.14, 95% CI 0.85–1.52, p=0.38). Conclusion In this registry of diabetic patients treated by drug-eluting stents, women were less represented, older and needed more insulin compared to men who, on the other hand, received larger stents. Gender-related outcomes were similar and female sex did not predict MACE.

OBJECTIVE: Drug-eluting stents are more effective in reducing restenosis than bare-metal stents. Paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) are the most widely used first-generation drug-eluting stents, but long-term comparative data on these are scant. The aim of the present report is to investigate the 6-year clinical outcomes of PES versus SES in a matched cohort of single-center registry patients. MATERIALS AND METHODS: Data were obtained from the observational, monocentric registry of 632 consecutive patients who underwent percutaneous coronary intervention between September 2002 and September 2005 with PES or SES. We assessed the composite and separate occurrence of the major adverse cardiac events (MACE), including death, nonfatal myocardial infarction, and target lesion revascularization (TLR). RESULTS: After a propensity 1 : 1 matching analysis, baseline clinical, procedural, and angiographic characteristics were well balanced between the two groups. Throughout the 6 years of follow-up, there were no significant differences between PES and SES in terms of MACE (P=0.52), all-cause death (P=0.24), myocardial infarction (P=0.25), stent thrombosis (P=0.38), and TLR (P=0.68). The sensitivity analysis on the total unmatched population confirmed this result, the stent type not being predictive of MACE (PES vs. SES group, hazard ratio 0.97, 95% confidence interval 0.66-1.41, P=0.87) or TLR (PES vs. the SES group, hazard ratio 1.35, 95% confidence interval 0.69-2.64, P=0.38). CONCLUSION: In this 'real-life' registry, PES and SES showed a comparable safety and efficacy profile throughout the 6 years of follow-up. The increase in the rate of TLR was slow and comparable between the two groups, even though the 'late catch-up' phenomenon showed a different temporal pattern between PES and SES.

The optimal percutaneous coronary intervention (PCI) revascularization strategy in patients with multivessel (MV) coronary artery disease (CAD) who present with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) has not been systematically addressed. Accordingly, we performed a study-level meta-analysis comparing 2 PCI strategies in these patients—infarct-related artery (IRA) only versus MV revascularization. Studies including patients with AMI and MV CAD complicated with CS who received primary PCI were searched from 2000 to 2016. The primary end points were in-hospital/30-day and mid- to long-term (≥6 month) mortality. Fixed and random effects models were used for analysis. Ten studies (9 prospective and 1 retrospective) involving 6,068 patients met our inclusion criteria. IRA-only PCI was the most frequently used revascularization strategy (4,872 patients, 80%), while MV PCI was performed in 1,196 patients (20%). The MV PCI strategy was associated with higher short-term mortality compared with the IRA-only PCI strategy (odds ratio 1.41, 95% confidence interval 1.15 to 1.71, p = 0.008). There was no difference in mid- to long-term mortality between MV PCI and IRA-only strategies (odds ratio 1.02, 95% confidence interval 0.65 to 1.58, p = 0.94). In conclusion, in patients with AMI and MV CAD complicated by CS, the IRA-only PCI strategy seems to be associated with lower short-term, but not mid- to long-term mortality compared with MV PCI. This finding is different from the revascularization strategy recommended by current professional guidelines and suggests the need for dedicated randomized clinical trials.

The authors conducted a systematic pairwise and network meta-analysis to assess optimal treatment strategies in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MV-CAD) undergoing primary percutaneous coronary intervention (PCI).Patients with STEMI and MV-CAD have a worse prognosis than those with single-vessel CAD. The optimal revascularization strategy for these patients is uncertain.Studies of revascularization strategies for MV-CAD in STEMI patients undergoing primary PCI published between 2001 and 2015 were identified using an electronic search. Pairwise and network meta-analyses were performed for 3 PCI strategies in prospective and retrospective studies: 1) infarct-related artery (IRA)-only PCI; 2) single procedure MV-PCI; and 3) staged MV-PCI. Information on study design, inclusion and exclusion criteria, and clinical outcomes was extracted. The outcomes of interest were short-term and long-term mortality.Thirty-two studies (13 prospective and 19 retrospective) with 54,148 patients (IRA-only PCI [n = 42,112], single procedure MV-PCI [n = 8,138], and staged MV-PCI [n = 3,898]) were included in the analysis. Pairwise meta-analyses showed that staged MV-PCI was associated with lower short-term and long-term mortality compared with both IRA-only PCI and single stage MV-PCI, whereas IRA-only PCI was associated with lower mortality compared with single stage MV-PCI. Staged MV-PCI was also associated consistently with improved survival in network analyses.The present systematic review and meta-analysis supports the hypothesis that in patients with MV-CAD presenting with STEMI undergoing primary PCI, a staged multivessel revascularization strategy may improve early and late survival.

We report the case of a man affected by non-valvular atrial fibrillation in whom a severely enlarged left atrial appendage with a narrow neck was successfully closed with a 34 mm Amplatzer Amulet device (St. Jude Medical). In the presence of a huge appendage with a narrow neck, as in this case, the Amulet should be considered an available option to ensure the feasibility of percutaneous closure.

Endomyocardial biopsy is a common procedure for monitoring cardiac allograft rejection; several techniques have been described so far, throughout different access sites and under echocardiographic or X-ray control. We describe the routine technique adopted at our centre based on echo-guided puncture of jugular vein and echocardiographic assessment of endomyocardial sampling with direct visualization of the bioptome tip. We also report the most common complications of the procedure, especially concerning the risk of iatrogenic tricuspid regurgitation, and same examples of histopathological findings drawn from our own iconographic collection.

This study aims to develop and validate a new angiographic risk score to predict the risk of distal embolization (DE) during primary percutaneous coronary intervention (p-PCI) for ST-elevation myocardial infarction. Study included data from 1,200 patients who underwent p-PCI. The cohort was randomly split into a derivation cohort (n = 814) and a validation cohort (n = 386). Logistic regression was used to examine the relation between risk factors and the occurrence of DE. To each covariate in the model was assigned an integer score based on the regression coefficients. Variables included in the risk score, according to multivariable analysis, were occlusion pattern of infarct-related artery, Thrombolysis In Myocardial Infarction Thrombus Score 2 to 4, reference vessel diameter ≥3.5 mm, and lesion length >20 mm. To each variable was assigned a 0- to +2-point score according to the strength of the statistical association. Rates of DE in low-, intermediate-, and high-risk groups were 5.6%, 15.8%, and 40% in the derivation cohort (p for trend

Transesophageal echocardiography (TEE) represents the gold standard technique to detect left atrial appendage (LAA) thrombosis. Several conditions may be erroneously interpreted as LAA thrombus at TEE, including artifacts mimicking thrombi. We report a case of a 78-year-old man with atrial fibrillation and contraindication to anticoagulation who was referred to our institution for percutaneous left appendage closure with a transcatheter trans-septal approach. Intraoperative transesophageal echocardiography revealed a thrombus-mimicking image, related to reverberations of left upper pulmonary vein ridge, located at twice the distance of the ridge from the transducer.