In-Hospital and Mid-Term Outcomes of ECMO Support During Coronary, Structural, or Combined Percutaneous Cardiac Intervention in High-Risk Patients - A Single-Center Experience.

INTRODUCTION: Evidence regarding the impact of prophylactic implantation of Extracorporeal Membrane Oxygenation (ECMO) during coronary or structural procedures is limited. The purpose of this paper is to evaluate the in-hospital and medium term outcomes of ECMO support in complex percutaneous coronary or structural intervention. METHODS: The present is an observational prospective study including consecutive patients who underwent to prophylactic ECMO implantation for percutaneous coronary intervention (PCI), structural or combined interventions between July 2018 and July 2020 in Maria Pia Hospital GVM Care & Research, Turin, Italy. Primary endpoints were in-hospital and medium term all-cause death. Secondary endpoints were vascular complication, bleeding and procedural success. RESULTS: 27 patients were included with a mean age of 80 ± 6 years, 10 (37%) being diabetics and 19 (70%) with severe left ventricle dysfunction. Mean Logistic Euroscore was 28.7 ± 18.7. Seven patients (26%) underwent complex coronary revascularization, 7 (26%) combined PCI + TAVI, 5 (19%) combined PCI + Mitraclip, 5 (19%) TAVI alone and finally 3 (11%) combined TAVI + Mitraclip. The procedural success was 96%, with only one in-hospital death due to major vascular complication at the ECMO vascular access. At a mean follow-up of 11 ± 6.8 months 4 deaths were recorded (3 from not cardiovascular causes). CONCLUSIONS: Prophylactic use of ECMO may be beneficial for high risk patients undergoing complex combined coronary/structural percutaneous interventions with good in-hospital and mid-term outcomes in term of safety and procedural success.

[Percutaneous treatment of double valve defect with a modified extracorporeal membrane oxygenation system]. / Trattamento percutaneo di doppio vizio valvolare con sistema di ossigenazione extracorporea a membrana modificato.

Extracorporeal membrane oxygenation (ECMO) has been developed to provide hemodynamic support in patients with severe cardiac or respiratory failure. In the last few years, its use has become increasingly common in interventional cardiology rooms for high-risk coronary interventions and for transcatheter therapies for valvular disease, which are increasingly complex in subsets of fragile patients at high surgical risk and with multiple comorbidities.Here, we describe the treatment of an extremely critical patient for severe dual valvulopathy, severe impairment of post-infarct systolic function, advanced heart failure with prohibitive operative risk. In a single session, the double valvular volume defect was treated percutaneously, using ECMO with an additional drainage of the left ventricle, performing a transcatheter implantation of two aortic valve prostheses with the valve-in-valve technique and the implantation of two MitraClips with excellent final result.

Clinical Discussions in Antithrombotic Therapy Management : A Delphi Consensus Panel.

For some years now, direct-acting oral anticoagulants (DOACs) have entered the clinical practice for stroke prevention in non-valvular atrial fibrillation (NVAF) or prevention and treatment of venous thromboembolism (VTE). However, there is uncertainty on DOAC use in some clinical scenarios not fully explored by clinical trials, but commonly encountered in the real world. We report a Delphi Consensus on DOAC use in NVAF and VTE patients. The consensus dealt with 16 main topics: (1) clinical superiority of DOACs compared to VKAs; (2) DOACs as a first-line treatment in patients with AF; (3) therapeutic options for patients undergoing electrical cardioversion; (4) selection of patients suitable for switching from VKAs to DOACs; (5) and (7) role of general practitioners in the follow-up of patients receiving a DOAC; (6) duties of Italian oral anticoagulation therapy centers; (8) role of therapy with DOACs in oncological patients with NVAF; (9) role of DOACs in oncological patients with VTE; (10) methods for administration and therapy compliance for DOACs; (11) drug interactions; (12) safety of low doses of DOACs; (13) therapeutic management of frail patients with NVAF; (14) therapeutic management of NVAF patients with glomerular filtration rate <30 ml/min (15); advantages of DOACs for the treatment of frail patients; (16) limitations on therapeutic use of DOACs. Sixty-two cardiologists from Italy expressed their level of agreement on each statement by using a 5-point Likert scale (1: strongly disagree, 2: disagree, 3: somewhat agree, 4: agree, 5: strongly agree). Namely, votes 1-2 were considered as disagreement while votes 3-5 as agreement. Agreement among the respondents of ≥66% for each statement was considered consensus. A brief discussion about the results for each topic is also reported.

Impact of extracorporeal shockwave myocardial revascularization on the ischemic burden of refractory angina patients: a single photon emission computed tomography study.

BACKGROUND: Extracorporeal shockwave myocardial revascularization (ESMR) is a non-invasive treatment designed to improve symptoms in refractory angina (RA) patients. Enhanced perfusion through local vasodilation and neo-capillarization is postulated to be the mechanism of the observed clinical benefit. However, the impact of ESMR on the ischemic burden of RA patients has not been adequately assessed. METHODS: One-hundred twenty-one consecutive RA patients suitable for ESMR were treated. Twenty-nine RA patients not suitable for treatment were clinically followed-up as a control group for clinical endpoints. ESMR-treated patients underwent baseline and 6-month single photon emission computed tomography (SPECT) to evaluate the changes in ischemic burden. The operator was blinded to the pre/post-treatment status of the SPECT exam. The primary endpoint was the difference in summed stress score (SSS) and summed difference score (SDS) between follow-up and baseline SPECTs. Secondary endpoints included the changes in Canadian Cardiovascular Society (CCS) angina class and nitroglycerin use between 6-month follow-up and baseline. Clinical endpoints were further compared between ESMR-treated patients and the control group. RESULTS: Following ESMR, a significant reduction in the ischemic burden was observed (follow-up SSS: 14.2±10 vs. baseline SSS: 21.2±9.42, P<0.0001; follow-up SDS: 4.6±5.9 vs. baseline SDS 10.2±7.9, P<0.0001) including less patients with moderate to severe ischemia (19% vs. 46% P<0.0001). CCS class and nitroglycerin use were significantly reduced (CCS: 1.5±0.6 vs. 2.7±0.6, P<0.0001; patients needing nitroglycerin: 24% vs. 64%, P<0.0001). When compared to the control group, CCS class reduction, nitroglycerin use and hospitalizations were significantly lower for ESMR treated vs. non-treated RA patients at 6-month follow-up. CONCLUSIONS: In this single-center cohort of RA patients undergoing ESMR treatment and serial myocardial perfusion imaging, ESMR was associated with a significant reduction in the ischemic burden. These findings provide a physiological rationale and mechanism for the observed clinical benefit.

A single cystatin C determination before coronary angiography can predict short and long-term adverse events.

BACKGROUND: Cystatin C (CyC) role in the detection of contrast induced acute kidney injury (CIAKI) is controversial. This study assessed whether a single CyC determination before coronary angiography (CA)could predict CIAKI and long-term adverse events. METHODS: CyC was assessed before CA in 713 consecutive patients. CIAKI was the primary endpoint, defined as ≥0.3 mg/dl creatinine (sCR) increase at 48 h or ≥50% in 7-days. All-cause death, cardiovascular (CV)death and MACE (acute coronary syndrome, acute pulmonary edema,CV death) were secondary endpoints. Re-hospitalization, in-hospital death and worsening renal function were tertiary endpoints. RESULTS: CIAKI occurred in 47 (6.7%) patients. ROC analysis showed a good accuracy of CyC in the prediction of CIAKI (AUC 0.82,p < 0.01), compared with baseline sCR and sCR-eGFR (AUC 0.70 and 0.75 respectively, both p < 0.01). CyC was associated with 10-year CV-death, all-cause death and MACEs (AUC 0.76,0.74 and 0.64 respectively,all p < 0.01). A CyC cut-off value of 1.4 mg/L was not only accurate in predicting or ruling-out CIAKI following CA (97% negative predictive value, 84% specificity), but also useful as a prognostic marker for 10-year adverse events (50% vs.16% all cause mortality, 29% vs.3% CV death, 39% vs.13% MACE,all p < 0.01), re-hospitalizations (54% vs.35%,p < 0.01) and worsening renal function (34% vs.19%,p < 0.01). The strongest and independent risk factor for 10-year CV death was baseline CyC>1.4 mg/L (HR 17.3, 95% CI 1.94-155.1). CONCLUSIONS: A baseline determination of CyC before CA can accurately rule out CIAKI and predict adverse events in the long term. CIAKI can be ruled out before CA in 97% patients with a CyC value < 1.4 mg/L.

Same-day CIED implantation and discharge: Is it possible? The E-MOTION trial (Early MObilization after pacemaker implantaTION).

BACKGROUND: Despite the increasing number of cardiac implantable electronic devices (CIED) procedures worldwide, no guideline assessed postoperative mobilization protocols. Lacking evidences in literature, many centers require 24-hour immobilization and bed rest to minimize the risk of pacing lead (PL) dislodgement. Prolonged immobilization may futilely delay discharge, induce pain and reduced joint mobility especially in elderly patients. We examined whether early mobilization at 3-h after CIED surgery would result in higher complication rates, compared with standard 24-hour immobilization. METHODS: Consecutive patients undergoing CIED implantation were randomized to early (3-h) mobilization protocol with an arm sling support (E-motion group, EMG) vs. standard (24-h) immobilization (control group, CG). The primary end-point was 24-month PL dislodgement. Secondary safety end-point was any major intra-procedural complication (cardiac perforation, pericardial tamponade, valve damage, haemothorax, pneumothorax, myocardial infarction, peripheral embolus, TIA/stroke or death). RESULTS: Among 200 enrolled patients, 86% underwent pacemaker implantation (28% single-chamber, 72% dual-chamber device), 14% underwent ICD implantation (75% single-chamber, 25% dual-chamber device). PL fixation was mostly passive (97% atrial PL, 88% ventricular PL), without differences between EMG and CG (p = 0.99). No differences were observed in the incidence of 24-month PL dislodgement (3% in the EMG vs. 4% in the CG, p = 0.99). No major intra-procedural complications were observed. CONCLUSIONS: Early mobilization at 3-h following CIED surgery is safe and feasible compared with standard immobilization and is not associated with an increased risk of intra-procedural complications or 24-month lead dislodgment. So, same-day implantation and discharge might be possible.

Screening of depression in cardiology: A study on 617 cardiovascular patients.

BACKGROUND: Depression screening in the cardiovascular disease (CVD) care setting is under-performed, also because the issue of the optimal screening tools cut-off is still open. We analysed which HADS (Hospital Anxiety and Depression Scale) total score cut-off value shows the best properties in two groups of 357 Acute Coronary Syndrome (ACS) and 260 Chronic Coronary Artery Disease (CAD) hospitalized patients. METHODS: A Receiver Operating Characteristics (ROC) curve was plotted for both groups using the Montgomery-Asberg Depression Rating Scale (MADRS) as the criterion. Accuracy, positive (PPV) and negative (NPV) predictive values were computed for different cut-off scores. RESULTS: The ROC curves confirmed the excellent/very good accuracy of the HADS in both groups, with an area under the curve of 0.911 for the ACS and 0.893 for the CAD patients. The cut-off of 14 showed the best compromise between high sensitivity and good specificity in both groups, with high negative predicted values (95.5% and 92.4%, respectively). CONCLUSION: Using a cut-off value of 14, the HADS could be considered a good screening tool to identify hospitalized CAD and ACS patients requiring a more accurate depression assessment, in order to promptly plan the most appropriate treatment strategies and prevent the negative effects of depression in CVD patients.

Contrast-induced kidney injury: how does it affect long-term cardiac mortality?

AIMS: Contrast-induced acute kidney injury (CIAKI) is a common complication after coronary angiography or percutaneous revascularization (PCI). This study aimed to investigate the association of CIAKI with long-term cardiovascular adverse events. METHODS: In total, 980 patients undergoing coronary angiography/PCI were assessed in this prospective cohort study. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) and cardiac death (CVD) during an 8-year follow-up. Glomerular filtration rate change during the follow-up was the secondary endpoint.CIAKI was defined as a serum creatinine increase at least 0.3 mg/dl in 48 h or at least 50% in 7 days. RESULTS: CIAKI was observed in 69 patients (7%). Chronic kidney disease [relative risk (RR) = 4, P < 0.01], reduced ejection fraction (RR = 2.88, P < 0.01), CIAKI risk score at least 4 (RR = 2.64, P = 0.02), and emergency coronary angiography/PCI (RR = 3.87, P < 0.01) increased CIAKI risk, whereas statins were protective (RR = 0.32, P < 0.01).Patients with CIAKI had higher rates of 8-year cardiovascular adverse events: 54 versus 15% MACCE (RR = 6.67, P < 0.01), 38 versus 4% CVD (RR = 15.73, P < 0.01). Among other factors, CIAKI was the strongest predictor of 8-year MACCE (RR = 3.16, P < 0.01) and CVD (RR = 7.34, P < 0.01).During the follow-up, glomerular filtration rate declined drastically in CIAKI patients: 70 versus 39% had chronic kidney disease stage worsening (P < 0.01) and 8 versus 0.3% started hemodialysis (P < 0.01). CONCLUSION: We found a strong correlation between CIAKI and poor long-term cardiac outcomes. Apparently showing up as a transient, functional impairment of kidney function, CIAKI implies an organic damage with structural modifications leading to significant kidney deterioration over time, responsible for an increased risk of long-term cardiac events. Statins significantly reduced CIAKI occurrence. A careful management of high-risk patients is needed to limit long-term complications of coronary angiography/PCI.

High sensitive TROponin levels In Patients with Chest pain and kidney disease: A multicenter registry - The TROPIC study.

BACKGROUND: Accuracy of high sensitive troponin (hs-cTn) to detect coronary artery disease (CAD) in patients with renal insufficiency is not established. The aim of this study was to evaluate the prognostic role of hs-cTn T and I in patients with chronic kidney disease (CKD). METHODS: All consecutive patients with chest pain, renal insufficiency (eGFR < 60 mL/min/1.73 m2) and high sensitive troponin level were included. The predictive value of baseline and interval troponin (hs-cTnT and hs-cTnI) for the presence of CAD was assessed. RESULTS: One hundred and thirteen patients with troponin I and 534 with troponin T were included, with 95 (84%) and 463 (87%) diagnosis of CAD respectively. There were no differences in clinical, procedural and outcomes between the two assays. For both, baseline hs-cTn values did not differ be-tween patients with/without CAD showing low area under the curve (AUC). For interval levels, hs-cTnI was significantly higher for patients with CAD (0.2 ± 0.8 vs. 8.9 ± 4.6 ng/mL; p = 0.04) and AUC was more accurate for troponin I than hs-cTnT (AUC 0.85 vs. 0.69). Peak level was greater for hs-cTnI in patients with CAD or thrombus (0.4 ± 0.6 vs. 15 ± 20 ng/mL; p = 0.02; AUC 0.87: 0.79-0.93); no differences were found for troponin T assays (0.8 ± 1.5 vs. 2.2 ± 3.6 ng/mL; p = 1.7), with lower AUC (0.73: 0.69-0.77). Peak troponin levels (both T and I) independently predicted all cause death at 30 days. CONCLUSIONS: Patients with CKD presenting with altered troponin are at high risk of coronary disease. Peak level of both troponin assays predicts events at 30 days, with troponin I being more accurate than troponin T. (Cardiol J 2017; 24, 2: 139-150).

Prospective assessment of a palliative care tool to predict one-year mortality in patients with acute coronary syndrome.

BACKGROUND: Identifying patients with acute coronary syndrome (ACS) who are approaching the end of life and who may not benefit from an aggressive interventional approach is important but clinically challenging. The Gold Standards Framework (GSF) prognostic guide was developed using multidimensional criteria to identify cancer patients who could benefit from end-of-life care. We assessed the utility of the GSF to predict one-year mortality in ACS patients. METHODS: ACS patients admitted between May 2012 and July 2013 at the three participating cardiac centres in Europe were enrolled. Patients were assessed during admission using the GSF, the Global Registry of Acute Coronary Events (GRACE) score, the age, creatinine, ejection fraction (ACEF) score and the New York Percutaneous Coronary Intervention (NY-PCI) risk score. The pre-specified primary outcome was all-cause mortality at one year; secondary outcomes were cardiovascular death, non-cardiovascular mortality, re-hospitalisation for ACS and re-hospitalisation for non-ACS causes. RESULTS: Six hundred and twenty-nine ACS patients were enrolled and one-year follow-up data was available for 626 patients. Fifty-two patients (8.3%) met GSF criteria for end-of-life care. These patients were older, predominantly female, had lower body mass index (BMI), and were less likely to receive angiography (75% vs 95%, p<0.001) and angioplasty (60% vs 77%, p=0.005) compared with patients who did not meet GSF criteria. Patients meeting GSF criteria had higher one-year all-cause mortality (42.3% vs 4.5%, p<0.001), cardiovascular mortality (15.4% vs 2.8%, p<0.001) and non-cardiovascular mortality (26.9% vs 1.7%; p<0.001). Multivariate analysis confirmed that meeting GSF criteria independently predicted all-cause mortality. CONCLUSION: GSF is a multidimensional tool which may be used to identify ACS patients that are at high risk of death and may benefit from end-of-life care.

Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry.

OBJECTIVES: The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease. BACKGROUND: TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance. METHODS: The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers. RESULTS: At a median follow-up of 1,295 days (interquartile range: 928 to 1,713 days), all analyses showed no difference in combinations of death, myocardial infarction, and cerebrovascular accident between PCI and CABG. When target vessel revascularization was incorporated in the composite endpoint, the TTE (p = 0.03), Andersen-Gill (p = 0.04), WR (p = 0.025), and competing risk (p < 0.001) computing methods showed CABG to be significantly superior to PCI in the analysis of 1,204 propensity-matched patients, whereas incorporating the clinical relevance of the component endpoints using WCE resulted in marked attenuation of the treatment effect of CABG, with loss of significance for the difference between revascularization strategies (p = 0.10). CONCLUSIONS: In a large study of ULMCA revascularization, incorporating the clinical relevance of the individual outcomes resulted in sensibly different findings as compared with the conventional TTE approach. In particular, using the WCE computing method, PCI and CABG were no longer significantly different with respect to the composite of death, myocardial infarction, cerebrovascular accident, or target vessel revascularization at a median of 3 years.

Long-term clinical outcomes after percutaneous coronary intervention versus coronary artery bypass grafting for acute coronary syndrome from the DELTA registry: a multicentre registry evaluating percutaneous coronary intervention versus coronary artery bypass grafting for left main treatment.

AIMS: Our aim was to compare, in a large unprotected left main coronary artery (ULMCA) all-comer registry, the long-term clinical outcome after percutaneous coronary intervention (PCI) with first-generation drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) in patients with acute coronary syndrome (ACS). METHODS AND RESULTS: Of a total of 2,775 patients enrolled in the Drug Eluting Stents for Left Main Coronary Artery Disease (DELTA) multicentre registry, 379 (13.7%) patients with ACS treated with PCI (n=272) or CABG (n=107) were analysed. Baseline demographics were considerably different in the two groups before propensity matching. No significant differences emerged for the composite endpoint of all-cause death, myocardial infarction (MI), and cerebrovascular accident (HR 1.11, 95% CI: 0.63-1.94; p=0.727), all-cause death (HR 1.26, 95% CI: 0.68-2.32; p=0.462), the composite endpoint of all-cause death and MI (HR 1.02, 95% CI: 0.56-1.84; p=0.956), and major adverse cardiac and cerebrovascular events (HR 0.82, 95% CI: 0.50-1.36; p=0.821). However, a higher incidence of target vessel revascularisation (HR 4.67, 95% CI: 1.33-16.47; p=0.008) was observed in the PCI compared with the CABG group, which was confirmed in the propensity score-matched analysis. CONCLUSIONS: In the DELTA all-comer, multinational registry, PCI for ACS in ULMCA is associated with comparable clinical outcomes to those observed with CABG at long-term follow-up, despite the use of first-generation DES.

AKIGUARD (Acute Kidney Injury GUARding Device) trial: in-hospital and one-year outcomes.

AIMS: Contrast-induced acute kidney injury (CIAKI) in patients with chronic kidney disease undergoing coronary angiography or percutaneous coronary intervention is a common iatrogenic complication associated with increased morbidity and mortality. This study compares sodium bicarbonate/isotonic saline/N-acetylcysteine/vitamin C prophylaxis (BS-NAC) against high-volume forced diuresis with matched hydration in CIAKI prevention. METHODS: One-hundred and thirty-three consecutive patients undergoing coronary angiography or percutaneous coronary intervention with estimated glomerular filtration rate less than 60 mL/min/1.73m were randomized to the study group receiving matched hydration (MHG) or to the control group receiving BS-NAC. MHG received in vein (i.v.) 250 mL isotonic saline bolus, followed by a 0.5 mg/kg furosemide i.v. bolus to forced diuresis. A dedicated device automatically matched the isotonic saline i.v. infusion rate to the urinary output for 1 h before, during and 4 h after the procedure. RESULTS: MHG had the lowest incidence of CIAKI (7 vs. 25%, P = 0.01), major adverse cardiac and cerebrovascular events at 1 year (7 vs. 32%, P < 0.01) and readmissions to cardiology/nephrology departments (8 vs. 25%, P = 0.03; hospitalization days 1.0 ±â€Š3.8 vs. 4.9 ±â€Š12.5, P = 0.01). Three months after the procedure the decrease in the estimated glomerular filtration rate was 0.02% for MHG versus 15% for the control group. CONCLUSION: Matched hydration was more effective than BS-NAC in CIAKI prevention. One-year follow-up showed that matched hydration was associated also with limited chronic kidney disease progression, major adverse cardiac and cerebrovascular events and hospitalizations.

Recurrent cerebral ischemia after patent foramen ovale percutaneous closure in older patients: A two-center registry study.

OBJECTIVES: The aim of this study is to describe the cerebral ischemia recurrence rate after percutaneous patent foramen ovale (PFO) closure in patients older than 55 years and their outcomes, compared with younger patients. BACKGROUND: The registries data and the recent randomized trials about PFO closure are focused on patients younger than 55 years. Little is known about older patients' long-term outcome. METHODS: In total, 458 patients underwent PFO closure for cryptogenic cerebral ischemia and were stratified into an "older" (≥ 55 years, 151 patients) and a "younger" (<55 years, 307 patients) group. RESULTS: Older patients had mean age of 63 ± 6 years and more atrial septum aneurysm (P = 0.05), hypertension, diabetes, and dyslipidemia (P = 0.001). Mean followup was 4.5 ± 2.8 years. Older patients had a higher rate of ischemic recurrence (0.3 vs. 4.0%, P = 0.002), after a mean time of 3.1 ± 2.6 years. The Kaplan-Meier curve confirmed higher event-free survival in the youngers (P = 0.008). None of the patients with ischemic recurrence had significant residual shunt. Age and hypertension were correlated to ischemic recurrence, but age was the only independent predictor at multivariate analysis. CONCLUSIONS: Recurrent cerebral ischemia after PFO closure is more frequent in older patients and could most likely be associated to conditions related to age (atherosclerosis, atrial fibrillation), than to paradoxical embolism. The procedure is as safe as in younger patients.

THE STORM (acute coronary Syndrome in paTients end Of life and Risk assesMent) study.

INTRODUCTION: Elderly patients with coexisting frailty and multiple comorbidities frequently present to the emergency department (ED). Because non-cardiovascular comorbidities and declining health status may affect their life expectancy, management of these patients should start in the ED. This study evaluated the role of Gold Standards Framework (GSF) criteria for identifying patients with acute coronary syndromes (ACS) approaching end of life. METHODS: All consecutive patients admitted to the ED and hospitalised with a diagnosis of ACS between May 2012 and July 2012 were included. According to GSF criteria, patients were labelled as positive GSF status when they met at least one general criterion and two heart disease criteria; furthermore, traditional cardiovascular risk scores (the Global Registry for Acute Coronary Events (GRACE) score and the Age, Creatinine and Ejection Fraction (ACEF) score) were calculated and WHOQOL-BREF was assessed. Mortality and repeat hospitalisation due to cardiovascular and non-cardiovascular causes were evaluated at 3-month and 12-month follow-up. RESULTS: From a total of 156 patients with ACS enrolled, 22 (14%) had a positive GSF. A positive GSF was associated with higher rate of non-cardiovascular events (22.7% vs 6.7%; p=0.03) at 3 months and higher rates of both cardiovascular and non-cardiovascular events (36% vs 16.4%; p=0.04 and 27.3% vs 6.7%; p=0.009, respectively) at 12 months. In multivariate analysis, an in-hospital GRACE score was a predictor of cardiovascular events, while a positive GSF independently predicted non-cardiovascular events. CONCLUSIONS: The GSF score independently predicts non-cardiovascular events in patients presenting with ACS and may be used along with traditional cardiovascular risk scores in choosing wisely the most appropriate treatment. The present results need to be externally validated on larger samples.

Outcomes of Patients Undergoing Balloon Aortic Valvuloplasty in the TAVI Era: A Multicenter Registry.

BACKGROUND: Few clinical data about indications and prognoses of patients undergoing balloon aortic valvuloplasty (BAV) in the transcatheter aortic valve implantation (TAVI) era have been reported. METHODS: Data from all consecutive patients undergoing BAV in seven European centers from 2006 to 2013 were collected. Acute results and long-term outcomes were assessed. RESULTS: A total of 811 patients aged 82 ± 9 years were included; 416 patients (51%) underwent BAV as palliative destination therapy, 320 patients (40%) as bridge to TAVI, and 75 patients (9%) as bridge to surgical aortic valve replacement (SAVR). Patients undergoing BAV as destination therapy had a higher risk profile (logistic EuroSCORE, 20 ± 17 vs 22 ± 14 vs 11 ± 8, respectively; P<.001). Post procedure, peak gradient decreased from 87 ± 22 mm Hg to 66 ± 22 mm Hg (P<.001) and aortic valve area increased from 0.61 ± 0.2 cm2 to 0.8 ± 0.2 cm2 (P<.001). At 30 days, the all-cause death rate (6.5% vs 6.2% vs 7.4%, respectively; P=.56) and the rate of life-threatening and major bleedings (8.0% vs 5.7% vs 6.0%, respectively) did not differ between groups. After a mean follow-up of 318 days (range, 116-500 days), rates of all-cause death were similar (30% vs 34% vs 31%, respectively; P>.99), although patients undergoing BAV as bridge to SAVR showed a lower cardiovascular death rate (11% vs 11% vs 3%, respectively; P=.04). CONCLUSION: In the TAVI era, BAV may represent a reasonable option for patients with severe aortic stenosis and temporary contraindications to definite therapy. Given the mortality rates at 30 days, patients should be carefully selected, while events at follow-up are deeply influenced by the decision of whether or not subsequent interventions are performed.

Supraventricular Arrhythmias in Patients With Pulmonary Arterial Hypertension.

The onset of supraventricular arrhythmias (SVA) may be associated with clinical worsening in patients with pulmonary arterial hypertension (PAH). However, limited data have been reported, especially at long-term follow-up. Aim of this study was to investigate the incidence of SVA in our patients with PAH, the risk factors correlated to their onset and the prognostic impact. All consecutive patients with PAH without history of SVA were enrolled. Incidence of new SVA was investigated and also the risk factors for SVA. Primary end point of the study was the impact of SVA on a composite of all-cause mortality and re-hospitalization, whereas mortality was the secondary end point. Seventy-seven patients were enrolled. No significant differences in the clinical or instrumental baseline characteristics between the 2 study groups were reported. During a median follow-up of 35 months (interquartile range 21.5 to 53.5), 17 (22%) patients experienced SVA. Development of SVA was associated with worsening of prognostic parameters at the follow-up: increasing of World Health Organization (WHO) functional class (p = 0.005) and N-terminal-pro-brain natriuretic peptide (NT-proBNP) (p = 0.018) and reduction of 6-minute walking distance (p = 0.048), tricuspid annular plane systolic excursion (TAPSE) (p = 0.041), and diffusing capacity of the lung for carbon monoxide (p = 0.025). The primary end point occurred in 13 patients (76%) in the SVA group and in 22 patients (37%) in the group without SVA (p = 0.004), whereas 9 patients (53%) among those with SVA died during the follow-up compared with 8 (13%) among those without (p = 0.001). At multivariate analysis, development of SVA was independently associated with an increased risk to meet the both primary (hazard ratio 2.13; 95% confidence interval 1.07 to 4.34; p = 0.031) and secondary (hazard ratio 4.1; 95% confidence interval 1.6 to 10.6; p = 0.004) end points. In conclusion, during the 3-year follow-up period, 1/3 of patients with PAH developed SVA, which was related to worsening of hemodynamic and functional parameter and independently predicted adverse prognosis.

Coronary Thrombosis and Type A Aortic Dissection.

A 74-year-old female had urgent surgery with replacement of the ascending aorta for acute type A dissection. Postprocedure, the electrocardiogram showed an ST-segment elevation myocardial infarction in the antero-lateral leads. Angiography revealed a thrombotic occlusion of the left anterior descending artery, treated successfully with bivalirudin administration, thrombus aspiration and a balloon angioplasty. This case involves the rare coexistence of acute type A aortic dissection and myocardial infarction due to coronary plaque thrombosis.

Meta-analysis of the usefulness of Mitraclip in patients with functional mitral regurgitation.

Midterm outcomes for patients presenting with heart failure and functional mitral regurgitation (MR) treated with Mitraclip remain unclear. Pubmed, Medline, and Google Scholar were systematically searched for studies enrolling patients with severe-moderate MR who underwent Mitraclip implantation. All events after at least 6 months were the primary safety end point (including death, rehospitalization for heart failure, and reinterventions), whereas change in the ejection fraction, left ventricular volumes, arterial pulmonary pressure, and left atrial diameters were considered as secondary end points. Meta-regression analysis was performed to evaluate the effect of baseline clinical and echocardiographic parameters on efficacy outcomes: 875 patients were included in 9 studies; 1.48 clips (1.3 to 1.7) for patients were implanted, and after a median follow-up of 9 months (6 to 12), 409 patients (78% [75% to 83%]) were in class New York Heart Association I/II and 57 (11% [8% to 14%]) still had moderate-to-severe MR. Overall adverse events occurred in 137 (26% [20% to 31%]) of the patients and 78 (15% [1% to 17%]) of them died; 6-minute walk test improved by 100 m (83 to 111), whereas a significant reduction in left ventricular volumes and systolic pulmonary pressure was reported. At meta-regression analysis, an increase in left ventricle systolic volumes positively affected reduction of volumes after Mitraclip, whereas atrial fibrillation reduced the positive effect of the valve implantation on ejection fraction on end-diastolic and -systolic volumes. In conclusion, Mitraclip represents an efficacious strategy for patients with heart failure and severe MR. It offers a significant improvement in functional class and in cardiac remodeling, in patients with severely dilated hearts as well, although its efficacy remains limited in the presence of atrial fibrillation.