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Background: Several studies have evaluated preprocedural imaging predictors of left ventricular outflow tract obstruction (LVOTO) after transcatheter mitral valve replacement. The patient cohorts in these studies were heterogeneous and included patients with transcatheter mitral valve replacement in failed bioprostheses, annuloplasty rings, and severe mitral annular calcification (MAC). The goal of this study was to evaluate predictors of LVOTO specific to patients undergoing valve-in-MAC. Methods: This study included patients with severe MAC who underwent valve-in-MAC and had optimal quality preprocedural multidetector row computed tomography scans eligible for retrospective analysis. Baseline demographic, echocardiographic, and procedural data on these patients were collected. multidetector row computed tomography parameters were analyzed for association with LVOTO, defined as increase in mean LVOT gradient by ≥10 mm Hg with accompanying hemodynamic instability. Results: Seventy-one patients with optimal preprocedural computed tomography scans were included in this study (mean age, 72.5±13.5 years), 9 of which developed LVOTO (all female). Baseline mean LVOT area, neo-LVOT area (145.3 versus 270.9 mm 2 ; P =0.006), indexed neo-LVOT area (90.1 versus 157.4; P =0.05), and virtual transcatheter heart valve to septum distance (3.1 versus 6.9 mm; P =0.002) were lower in the LVOTO group. Expected % LVOT area reduction was higher in the latter group (58.3 versus 42.7%; P =0.008). In the univariable analysis, the baseline mean LVOT area, neo-LVOT area, indexed neo-LVOT area, and valve to septum distance were all significantly associated with LVOTO. Conclusions: The systolic mean LVOT area, neo-LVOT area, indexed neo-LVOT, expected percentage LVOT area reduction, and the valve to septum distance were associated with LVOTO after valve-in-MAC.

The long-term outcomes after transcatheter closure of atrial septal defects (ASD) in adults are reported and compared between age groups and against population control patients.ASD is the second most common lesion in congenital heart disease. Comprehensive data on long-term outcomes after ASD closure are limited.This retrospective cohort study enrolled adult patients with secundum ASD closure between 1998 and 2016. Information from a detailed clinical registry was linked to population-based administrative databases to capture outcomes. The population control cohort was matched using important prognostic characteristics.The cohort included 1,390 ASD patients of whom 32% were 40 years of age, 45% were 40 to 60 years of age, and 23% were60 years of age at closure. The median follow-up was 10.6 years (interquartile range: 6.2 to 14.0 years). New-onset atrial fibrillation (AF) was the most frequent outcome overall (14.9%). The incidence of adverse cardiac and cerebrovascular events was higher in the60 years of age group than in the younger groups. In adjusted analysis, patients60 years of age continued exhibiting higher risk of all-cause (hazard ratio [HR]: 8.54; 95% confidence interval [CI]: 93.40 to 21.43) and cardiovascular (CV)-specific mortality compared with the 40 years of age group. The risk of new-onset AF (HR: 3.73; 95% CI: 2.79 to 4.98) and any AF hospitalization (HR: 1.55; 95% CI: 1.28 to 1.89) was higher in the ASD than in the control population, whereas there was no difference in all-cause and CV-specific mortality.As expected, rates of adverse events post-ASD closure are higher in older age groups, but long-term mortality was comparable to that of a population control cohort. The high rates of AF necessitate future investigations.

Background: University life is a chapter of all the enrolled students’ life where they face stressful events that could potentially lead to different levels of anxiety. Anxiety is a common phenomenon that causes poor academic achievements for most college students in the world. Higher state of anxiety, feeling low self-esteem, taking longer time to accomplish tasks, and spending more time for studying, are faced by college students who also worry about tests resulting or low grades. Aim: This study aimed to determine the anxiety level among university students during final exams, and to determine the relationship between students' characteristics and the level of test anxiety among King Faisal University Students in Al Hasa, Eastern Region, Saudi Arabia. Method: A cross-sectional study research design was utilized to conduct the current study on a sample of (N = 362 students) randomly chosen from King Faisal University students from different colleges. Informed consent was taken stating that the participants have the right to leave the study at any time. Students were asked to complete a questionnaire developed by Nist and Diehl (1990) in assessing Test Anxiety. Test anxiety score was measured among students between the age range 18 to 26 years. There was high level of test anxiety among level 3 students (25.3%) with (Mean ± SD=31.1±6.8) and among level 4 students (21.2%) with (Mean ± SD 30.5±6.5). The frequency of students with high anxiety was significantly increased in health college (28%). This means that there was a significant increase in the anxiety score in health colleges compared with non-health colleges. The prevalence of high level of test anxiety among university students was (19.1%).High level of test anxiety is noticed in our university students. Also, the result confirmed that there is a relationship between test anxiety and students’ characteristics. Conclusion: Anxietyis a natural response categorized by feelings of stress, anxious thoughts and bodily alterations like raised blood pressure. Moderate levels of anxiety are motivating and can improve students’ test performances. However, high level of anxiety could hinder and interfere with their academic performance. The current study focuses on the test anxiety level among undergraduate King Faisal University students. In this study, high level of test anxiety is noticed in the students. Also, the result confirmed that there is a relationship between test anxiety and students’ characteristics.

Despite rapidly increasing use of TAVR across institutions, limited data is available for the effect of procedural experience on TAVR outcomes. We investigate the relationship between institutional experience and TAVR outcomes.1953 patients undergoing TAVR at 8 international sites were grouped into chronological quantiles (Q) to assess temporal changes on procedural and clinical outcomes and multivariate logistic regression performed to determine predictors of device success, early safety and all-cause mortality.The mean age of patients was 81±7years and 991 (51%) were female. The quantiles comprised of first 62 cases for Q1, 63-133 for Q2, 134 to 242 for Q3 and 243 to 476 for Q4. Device success increased from Q1 to Q4 (78% vs 89%, p0.001) with significant improvement in the early safety endpoint (19% vs 10%, p0.001). All cause mortality reduced by half in Q4 compared to Q1 (8% vs 4%, p=0.01) and rates of major vascular complications, major bleeding and valve embolization decreased with increasing experience. The multivariate analysis identified TAVR in Q3 and Q4 to be independently associated with higher device success and lower risk of complications. TAVR in Q4 was independently associated with lower mortality (OR 0.36 95% CI 0.19-0.70, p=0.002).Greater institutional experience with TAVR procedures improves device success and clinical outcomes. An experience of242 cases is independently associated with lower mortality. These findings have important implications for defining minimum volume criteria for institutions and training standards for TAVR procedure.

Background Most patients undergoing Transcatheter aortic valve implantation (TAVR) are elderly with significant co-morbidities and there is limited information available regarding factors that influence length of stay (LOS) post-procedure. The aim of this study was to identify the patient, and procedural factors that affect post-TAVR LOS using a contemporary multinational registry. Methods We conducted a retrospective cohort study, with patients recruited from three high volume tertiary institutions. The primary outcome was the LOS post-TAVR procedure. We examined patient and procedural factors in a cause-specific Cox multivariable regression model to elucidate their effect on LOS, accounting for the competing risk of post-procedural death. Hazard ratios (HR) greater than 1 indicate a shorter LOS, while HRs less than 1 indicate a longer LOS. Results The cohort consisted of 809 patients. Patient factors associated with longer LOS were older age, prior atrial fibrillation, and greater patient urgency. Patient factors associated with shorter LOS were lower NYHA class, higher ejection fraction and higher mean aortic valve gradients. Procedural characteristics associated with shorter LOS were conscious sedation (HR = 1.19, 95% CI 1.06–1.35, p = 0.004). Transapical access was associated with prolonged LOS (HR = 0.49, 95% CI 0.41–0.58, p

Transcatheter atrial septal defect closure (TAC) is a well-established therapy for most patients with secundum atrial septal defects (ASD) based on short-term data ([1][1]). In previous surgical studies, mortality was not significantly different from age-and-sex matched control subjects ([2][2]).

This study aims to establish a computed tomography (CT)-based scoring system for grading mitral annular calcification (MAC) severity and potentially aid in predicting valve embolization during transcatheter mitral valve (MV) replacement using balloon-expandable aortic transcatheter heart valves.Transcatheter MV replacement is emerging as an alternative treatment for patients with severe MAC who are not surgical candidates. Although cardiac CT is the imaging modality of choice in the evaluation of candidates for valve-in-MAC (ViMAC), a standardized grading system to quantify MAC severity has not been established.We performed a multicenter retrospective review of cardiac CT and clinical outcomes of patients undergoing ViMAC. A CT-based MAC score was created using the following features: average calcium thickness (mm), degrees of annulus circumference involved, calcification at one or both fibrous trigones, and calcification of one or both leaflets. Features were assigned points according to severity (total maximum score = 10) and severity grade was assigned based on total points (mild ≤3, moderate 4 to 6, and severe ≥7 points). The association between MAC score and device migration/embolization was evaluated.Of 117 patients in the TMVR in MAC registry, 87 had baseline cardiac CT of adequate quality. Of these, 15 were treated with transatrial access and were not included. The total cohort included 72 (trans-septal = 37, transapical = 35). Mean patient age was 74 ± 12 years, 66.7% were female, and the mean Society of Thoracic Surgery risk score was 15.4 ± 10.5%. The mean MAC score was 7.7 ± 1.4. Embolization/migration rates were lower in higher scores: Patients with a MAC score of 7 had valve embolization/migration rate of 12.5%, MAC score ≥8 had a rate of 8.7%, and a MAC score of ≥9 had zero (p = 0.023). Patients with a MAC score of ≤6 had 60% embolization/migration rate versus 9.7% in patients with a MAC score ≥7 (p 0.001). In multivariable analysis, a MAC score ≤6 was in independent predictor of valve embolization/migration (odds ratio [OR]: 5.86 [95% CI: 1.00 to 34.26]; p = 0.049).This cardiac CT-based score provides a systematic method to grade MAC severity which may assist in predicting valve embolization/migration during trans-septal or transapical ViMAC procedures.

The choice of antithrombotic therapy for atrial fibrillation (AF) patients who have an acute coronary syndrome (ACS) or have undergone percutaneous coronary intervention (PCI) is challenging. We aimed to assess outcomes between dual-antithrombotic therapy with the use of direct-acting oral anticoagulants (DOACs) plus an antiplatelet agent (dual therapy) compared with warfarin plus 2 antiplatelet agents (triple therapy) for AF patients after PCI or with ACS.Systematic searches of multiple major databases were performed from their inception through September 2019. We included only randomized controlled trials. Odds ratios (ORs) were pooled with the use of a random-effects model.We identified 4 randomized controlled trials, which included 7168 patients. Compared with triple-antithrombotic therapy with warfarin, dual-antithrombotic therapy with DOACs was associated with a significant reduction in major bleeding (OR 0.56, 95% confidence interval [CI] 0.38-0.82; P = 0.003) as well as major bleeding or clinically relevant nonmajor bleeding (OR 0.53, 95% CI 0.38-0.75; P0.001). The rate of composite of death and ischemic events (stroke and myocardial infarction) was not statistically different between groups (OR 1.21, 95% CI 0.99-1.49; P = 0.06). There was no significant difference between groups in the rate of death (OR 1.20, 95% CI 0.95-1.53; P = 0.13).In patients with AF and recent ACS or PCI, the use of dual-antithrombotic therapy with DOACs was associated with less major bleeding and less major bleeding or clinically relevant nonmajor bleeding compared with triple therapy. The use of dual therapy also showed nonsignificantly higher composite of death and ischemic events but no difference in mortality.

Coronary artery fistulae (CAF) are rare congenital cardiac abnormalities. With increasing age, patients with moderate to large fistulae are likely to become symptomatic and encounter complications. Percutaneous closure has been accepted as a safe and effective alternative to surgery; however, information regarding long-term outcomes in adult patients after transcatheter closure is limited. METHODS We describe our 20-year experience with percutaneous closure of CAF in adult patients, focusing on long-term outcomes. RESULTS From 1995 to 2015, 25 adult patients underwent 33 transcatheter interventions to close 26 CAF at our institution. Mean age was 51.4 ± 16.8 years, and 14 (56%) were female. All the patients were symptomatic with dyspnea (21/25, 84%) being the most common complaint followed by chest pain (17/25, 68%), palpitations (9/25, 36%), and heart failure (2/25, 8%). Two patients presented with acute coronary syndrome, whereas 10/25 (40%) also had inducible ischemia on stress test. These CAFs were classified as medium (12, 46.2%), large (5, 19.2%), and giant (9, 34.6%). Immediately postprocedure complete occlusion was achieved in 21 (21/26, 81%), and residual trace leak was observed in three fistulae, whereas we could not deliver coils/device in two cases. Periprocedural complications occurred in the form of coronary dissection (n = 1), myocardial infarction (n = 2), coil embolization (n = 1), transient ST elevation (n = 1); the majority of complications were observed in the early years of our experience. Patients reported marked improvement in symptoms after the intervention. During a mean follow-up of 76 ± 69 (5-214 months) (n = 22), 15 patients were investigated by either conventional (n = 6) or CT angiography (n = 8) or both (n = 1) that demonstrated thrombotic occlusion of a proximal coronary artery where a distal fistula was treated. Another patient was noted to have thrombus proximal to a vascular plug in a distal giant fistula. Three patients were lost to follow-up. None of the investigated patients had recanalization of their fistula. We did not observe remodeling of the native coronary artery that was feeding the fistula, even after successful complete closure. CONCLUSION Percutaneous device closure of CAF is a feasible and effective therapeutic intervention in adult patients; however, patients with distal fistulas represent a significant challenge and the outcomes of these procedures are in question. All patients should have long-term angiographic follow-up.

Objectives To report the initial clinical experience with a novel atrial septal defect (ASD) closure device, the GORE® CARDIOFORM ASD Occluder (GCO). Background Transcatheter closure has become the treatment of choice for secundum ASD. A wide range of occluder devices are available, but concern has been raised about the risk of cardiac erosion associated with rigid devices and future access to the left atrium Methods Retrospective chart review of patients treated with the GCO at three Canadian centers. Primary outcomes were procedural success and residual shunting at follow-up, as well as 30-day major adverse events. Secondary outcomes included new onset atrial arrhythmias, wire frame fractures (WFF), and all cause mortality. Clinical, echocardiographic, procedural data, and follow-up outcome variables were collected in each participating hospital. Results Between February and December 2015, 26 patients (5 children and 21 adults) underwent transcatheter ASD closure with the GCO and were included in the study cohort. Procedural success was achieved in 22 of 26 patients (85%) and no major procedural complications were observed. Two patients (8%) presented new onset atrial tachyarrhythmia during early follow-up (0–30 days). Follow-up echocardiography (median of 119 days [IQR: 92–146]) demonstrated no residual shunt in all implanted patients. After a median clinical follow-up of 174 days (IQR: 135–239), one patient died of an unrelated cause, there were no documented major adverse cardiovascular events. Fluoroscopic imaging of the device was performed in 20 patients (91%), and WFF was noted in five cases. No clinical consequence or device dysfunction was observed in these patients. Conclusions In this first-in-man multicenter study, the GCO was safe and effective for ASD closure, with no major adverse events or residual shunt at follow-up. © 2017 Wiley Periodicals, Inc.

Objectives This study sought to evaluate the outcomes of the early experience of transcatheter mitral valve replacement (TMVR) with balloon-expandable valves in patients with severe mitral annular calcification (MAC) and reports the first large series from a multicenter global registry. Background The risk of surgical mitral valve replacement in patients with severe MAC is high. There are isolated reports of successful TMVR with balloon-expandable valves in this patient population. Methods We performed a multicenter retrospective review of clinical outcomes of patients with severe MAC undergoing TMVR. Results From September 2012 to July of 2015, 64 patients in 32 centers underwent TMVR with compassionate use of balloon-expandable valves. Mean age was 73 ± 13 years, 66% were female, and mean Society of Thoracic Surgeons score was 14.4 ± 9.5%. The mean mitral gradient was 11.45 ± 4.4 mm Hg and the mean mitral area was 1.18 ± 0.5 cm 2 . SAPIEN valves (Edwards Lifesciences, Irvine, California) were used in 7.8%, SAPIEN XT in 59.4%, SAPIEN 3 in 28.1%, and Inovare (Braile Biomedica, Brazil) in 4.7%. Access was transatrial in 15.6%, transapical in 43.8%, and transseptal in 40.6%. Technical success according to Mitral Valve Academic Research Consortium criteria was achieved in 46 (72%) patients, primarily limited by the need for a second valve in 11 (17.2%). Six (9.3%) had left ventricular tract obstruction with hemodynamic compromise. Mean mitral gradient post-procedure was 4 ± 2.2 mm Hg, paravalvular regurgitation was mild or absent in all. Thirty-day all-cause mortality was 29.7% (cardiovascular = 12.5% and noncardiac = 17.2%); 84% of the survivors with follow-up data available were in New York Heart Association functional class I or II at 30 days (n = 25). Conclusions TMVR with balloon-expandable valves in patients with severe MAC is feasible but may be associated with significant adverse events. This strategy might be an alternative for selected high-risk patients with limited treatment options.

Background: Owing to the limited data on long-term outcomes following the implantation of atrial septal occluders, their permanent nature and potential for adverse outcomes remain concerning. Methods: In this retrospective cohort study, the long-term outcomes of adult patients who underwent transcatheter and surgical closure at Peter Munk Cardiac Centre, Toronto, Canada between 1991-2015 were determined using administrative databases linkages. The transcatheter group was compared to an age-sex matched population (each included 1278 participants) in 1:1 fashion and to a surgical group (240 patients) using propensity weighting. The primary endpoint was all-cause mortality. Results: Median age was 48 years and 39 years for the transcatheter and surgical groups respectively. Compared to age-sex matched group, mortality following transcatheter closure was not significantly different after a median follow-up of 9 years [7.9 vs 6.4 per 1000-patient-years, (difference-95%CI, -0.68,4.49), P=0.20], with non-significantly different rates of stroke [1.9 vs 1.1 per 1000-patient-years, (difference-95% CI, -0.2,2.69), P=0.16] but significantly higher rates of atrial fibrillation [22 vs 4.4 per 1000-patient-years, (difference-95% CI, 11.6,25.9), P

OBJECTIVES: The aim of this study was to assess the incidence of persistently positive results on agitated saline contrast injection after patent foramen ovale (PFO) closure, the underlying mechanism, and management. BACKGROUND: Transcatheter intervention to close a PFO is reasonable in highly selected patients younger than 60 years, after a thorough cardioneurological investigation following a cryptogenic stroke, particularly in the presence of thromboembolic disease or in patients at high risk for venous thrombosis. The U.S. Food and Drug Administration approved the Amplatzer PFO Occluder in October 2016 for such an indication. Confirmation of PFO closure is usually verified by an agitated saline contrast injection during an echocardiographic examination. The appearance of bubbles in the left atrium raises the concern of incomplete closure or other sources of shunting. METHODS: The medical records and echocardiograms of patients who were treated with transcatheter closure of a PFO for cryptogenic stroke were reviewed. RESULTS: From January 1998 through December 2015, 880 patients were taken to the catheter laboratory for PFO closure, of whom 568 patients, 320 men (56.3%), underwent transcatheter closure of a PFO using an Amplatzer PFO Occluder, at a mean age of 48.1 ± 12.9 years. The incidence of right-to-left shunting (RLS) was 19.5% at a mean of 4 months' follow-up, which reduced to 8.4% at 11 ± 2 months. Sources of RLS were identified in 10 (1.8%); pulmonary arteriovenous malformation (n = 4) was the most common etiology, followed by leak through the device (n = 3). All patients with additional sources of RLS were treated percutaneously. At 2-year follow-up, 16 patients (2.8%) persisted with only mildly positive results on agitated saline contrast injection, without an apparent additional source of shunting. CONCLUSIONS: Coexistence of a PFO and an additional lesion responsible for RLS is uncommon, but not rare; the majority are amenable to transcatheter or surgical intervention. ispartof: JACC-CARDIOVASCULAR INTERVENTIONS vol:11 issue:11 pages:1095-1104 ispartof: location:United States status: published

Background Scarce data exist on the incidence of and factors associated with valve hemodynamic deterioration (VHD) after transcatheter aortic valve replacement (TAVR). Objectives This study sought to determine the incidence, timing, and predictors of VHD in a large cohort of patients undergoing TAVR. Methods This multicenter registry included 1,521 patients (48% male; 80 ± 7 years of age) who underwent TAVR. Mean echocardiographic follow-up was 20 ± 13 months (minimum: 6 months). Echocardiographic examinations were performed at discharge, at 6 to 12 months, and yearly thereafter. Annualized changes in mean gradient (mm Hg/year) were calculated by dividing the difference between the mean gradient at last follow-up and the gradient at discharge by the time between examinations. VHD was defined as a ≥10 mm Hg increase in transprosthetic mean gradient during follow-up compared with discharge assessment. Results The overall mean annualized rate of transprosthetic gradient progression during follow-up was 0.30 ± 4.99 mm Hg/year. A total of 68 patients met criteria of VHD (incidence: 4.5% during follow-up). The absence of anticoagulation therapy at hospital discharge (p = 0.002), a valve-in-valve (TAVR in a surgical valve) procedure (p = 0.032), the use of a 23-mm valve (p = 0.016), and a greater body mass index (p = 0.001) were independent predictors of VHD. Conclusions There was a mild but significant increase in transvalvular gradients over time after TAVR. The lack of anticoagulation therapy, a valve-in-valve procedure, a greater body mass index, and the use of a 23-mm transcatheter valve were associated with higher rates of VHD post-TAVR. Further prospective studies are required to determine whether a specific antithrombotic therapy post-TAVR may reduce the risk of VHD.

Purpose Short-term outcomes have been well characterized in acute coronary syndromes; however, longer-term follow-up for the entire spectrum of these patients, including ST-segment-elevation myocardial infarction, non-ST-segment-elevation myocardial infarction, and unstable angina, is more limited. Therefore, we describe the longer-term outcomes, procedures, and medication use in Global Registry of Acute Coronary Events (GRACE) hospital survivors undergoing 6-month and 2-year follow-up, and the performance of the discharge GRACE risk score in predicting 2-year mortality. Methods Between 1999 and 2007, 70,395 patients with a suspected acute coronary syndrome were enrolled. In 2004, 2-year prospective follow-up was undertaken in those with a discharge acute coronary syndrome diagnosis in 57 sites. Results From 2004 to 2007, 19,122 (87.2%) patients underwent follow-up; by 2 years postdischarge, 14.3% underwent angiography, 8.7% percutaneous coronary intervention, 2.0% coronary bypass surgery, and 24.2% were re-hospitalized. In patients with 2-year follow-up, acetylsalicylic acid (88.7%), beta-blocker (80.4%), renin-angiotensin system inhibitor (69.8%), and statin (80.2%) therapy was used. Heart failure occurred in 6.3%, (re)infarction in 4.4%, and death in 7.1%. Discharge-to-6-month GRACE risk score was highly predictive of all-cause mortality at 2 years (c-statistic 0.80). Conclusion In this large multinational cohort of acute coronary syndrome patients, there were important later adverse consequences, including frequent morbidity and mortality. These findings were seen in the context of additional coronary procedures and despite continued use of evidence-based therapies in a high proportion of patients. The discriminative accuracy of the GRACE risk score in hospital survivors for predicting longer-term mortality was maintained.

We appreciate the comments of Dr. Vavuranakis and colleagues regarding our recently published paper [(1)][1]. In their letter, Dr. Vavuranakis and colleagues emphasize that the differing distribution of coronary artery disease (CAD) across the patient and treatment groups within our study, more

ObjectiveWe aimed to analyse the incidence of prosthesis–patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event.MethodsA total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls).ResultsModerate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta −0.023; 95% CI −0.032 to –0.014; PConclusionsSevere PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation.

Introduction Cardiogenic shock is associated with significant mortality, particularly when caused by myocardial infarction. Intraaortic balloon pump (IABP) is the primary hemodynamic adjunct in patients with cardiogenic shock; however, evidence suggests that IABP may not improve mortality in this population. Methods We conducted an electronic search of the Medline, EMBASE, and Cochrane trial registry databases. Two reviewers independently screened citations and identified eligible trials. The same reviewers abstracted data independently. We pooled the data using a fixed effect model and reported dichotomous outcomes as risk ratios (RRs) with 95% confidence intervals (CIs). Subsequently, we used the GRADE approach to judge the quality of evidence. Results We included 4 randomized trials with 735 patients. The use of IABP did not reduce the risk of death in patients with cardiogenic shock secondary to cardiac ischemia when compared with usual care (RR, 0.94; 95% CI, 0.79-1.13; P = 0.52; I² = 0%; moderate confidence). The use of IABP was not associated with an increased risk of stroke (RR, 0.77; 95% CI 0.22-2.69; P = 0.68; I² = 48%; very low confidence), limb ischemia (RR, 1.24; 95% CI, 0.59-2.59; P = 0.58; I² = 0%; low confidence), or major bleeding (RR, 0.76; 95% CI, 0.34-1.72; P = 0.52; I² = 0%; low confidence). Conclusions The use of IABP in patients with cardiogenic shock complicating myocardial ischemia does not reduce mortality (moderate confidence) and is not associated with a higher risk of complications (very low to low confidence). The results should be interpreted with caution owing to limitations such as imprecision, risk of bias, and clinical heterogeneity.

Background Transcatheter Closure (TC) has become the main stay therapy for many secundum atrial septal defects (ASD) based on short and intermediate term outcome data. Long-term safety and efficacy of this approach among adult patients however, is not well established. Methods and results A comprehensive search of major electronic databases for studies reporting the long-term (≥5 year) outcomes post TC among adults yielded 114 studies, 9 of which had met the inclusion criteria. This included 1015 patients with a mean age of 45 years ± 5.5 years, two third were female with a mean follow up duration 6.4 years ± 2.7 years. The weighted proportions of long-term mortality and stroke with 95% confidence intervals (CI) were 2.4% (95%CI 0.9%–6.1%) and 2.1% (95%CI 0.7%–5.7%) respectively. Atrial arrhythmia occurred in 6.5% (95%CI 3.5%–11.7%) and atrial fibrillation in 4.9% (95%CI 1.9%–11.7%). ASD related re-interventions were encountered in 2.3% (95%CI 1.0%–5.4%) and residual shunt in 4.2% (95% CI 1.3%–12.4%), with 1 case of suspected device erosion 0.9% (95%CI 0.4–2.2%). Frame fractures and late migrations were observed at 4.2% (95%CI 1.5%–11.5%) and 1.2% (95%CI 0.3%–4%) respectively. No cases of occluder endocarditis or thrombosis were reported. In conclusion This is the first study that systematically analyzes the long-term outcomes after TC providing important estimates for various clinical and occluder related outcomes. The analysis suggests preserved long-term safety post TC; however, this is limited due to the variable quality of available evidence and requires further assessment by larger studies with more comprehensive follow-up data.

Background There is a paucity of data on the need for optimal medical therapy ( OMT ) in nonobstructive coronary artery disease . We sought to understand if there was variation in the use of OMT between hospitals for patients with nonobstructive coronary artery disease, the factors associated with such variation, and its clinical consequences. Methods and Results Using a population‐level clinical registry in Ontario, Canada, we identified all patients >66 years undergoing coronary angiography for the indication of stable angina, who had nonobstructive coronary artery disease between November 1, 2010, and October 31, 2013. Hierarchical multivariable logistic models were developed to identify the factors associated with OMT use, with median odds ratio used to quantify the degree of variation between hospitals not explained by the modeled risk factors. Clinical outcomes of interest were all‐cause mortality and rehospitalization, with follow‐up until March 31, 2015. Our cohort consisted of 5413 patients, of whom 2554 (47.2%) were receiving OMT within 1 year. There was a 2‐fold variation in OMT across hospitals (30.4%–61.8%). The variation between hospitals was fully explained by preangiography medication use (median odds ratio of 1.21 in the null model and 1.03 in the full model). There was no difference in risk‐adjusted mortality (hazard ratio, 0.94; 95% confidence interval, 0.76–1.16); however, patients receiving OMT had a lower risk of all‐cause hospital readmission (hazard ratio, 0.89; 95% confidence interval, 0.84–0.95). Conclusions There is wide variation in the use of OMT in patients with nonobstructive coronary artery disease, the major driver of which is differences in baseline medication use.

Aims The aim of this study was to examine the short- and medium-term outcomes of transcatheter aortic valve replacement (TAVR) with the self-expanding and repositionable Portico valve (St. Jude Medical, St. Paul, MN, USA). Methods and results A total of 57 patients underwent TAVR with the Portico valve between March 2012 and August 2014, representing the first-in-human experience and the entire early experience in Canada. Patients were followed up at 30 days and one year with repeat echocardiography and clinical review. Patients were 80.8±7.3 years of age, and the Society of Thoracic Surgeons predicted risk of mortality was 7.7±5.7%. All patients had a valve implanted and four patients (7%) required a second valve. At 30 days, there were two deaths (3.5%), three disabling strokes (5.3%), and new pacemakers in five (8.8%) patients. Echocardiography revealed moderate/severe aortic regurgitation in two patients (3.6%). At one year, survival was 84.2% and echocardiographic findings were unchanged. Conclusions Transcatheter aortic valve replacement with the repositionable Portico valve provides satisfactory short- and medium-term haemodynamic and clinical results.

Background— Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV). Methods and Results— Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm 2 ; P =0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; P =0.02), and lower core laboratory–adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; P =0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; P =0.03). Conclusions— In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation.

Background Studies showing an advantage of transradial approach (TR) for coronary angiography and intervention (PCI) compared to the transfemoral approach (TF) predominantly included a younger population. Therefore, we conducted a meta-analysis of published studies to determine the efficacy of TR in the elderly population. Methods and results A comprehensive search identified 16 studies [3 randomized controlled studies, 13 observational] comprising 777,841 elderly patients undergoing PCI. TR was used in 99,201 patients and TF in 678,640 patients. The results from observational studies showed that TR was associated with a lower rate of vascular complications (0.4% vs. 0.8%, OR 0.36, 95% CI 0.30–0.44), stroke (0.3% vs. 0.4%, OR 0.81, 95% CI 0.66–1.0) and death (2.0% vs. 2.2%, OR 0.51, 95% CI 0.41–0.63). RCTs confirmed findings from observational studies for both significant reduction in vascular complications (2.7% vs. 7%, OR 0.37, 95% CI 0.23–0.60) and stroke (0.4% vs. 1.4%, OR 0.31, 95% CI 0.10–0.97) but showed no effect on mortality (3.3% vs. 2.8%, OR 1.20, 95% CI 0.69–2.09). However, among patients with ST elevation myocardial infarction (STEMI), TR was associated with a mortality benefit (5% vs. 7%, OR 0.48, 95% CI 0.25–0.90, p =0.02). Access site crossover rate was higher for TR compared to the TF approach (11% vs. 3%, p =0.0003) but there was no difference in contrast media use, procedure duration, fluoroscopy time and door to balloon time for STEMI. Conclusion TR for PCI in the elderly is associated with a reduced risk of stroke, lower rate of vascular complications overall and a mortality benefit for patients presenting with STEMI. The access site cross rate for TR is higher compared to TF but remains acceptably low. TR should be the preferred strategy for PCI in the elderly to optimize clinical benefit in this high-risk group.

OBJECTIVES The study sought to examine the risk of ischemic events and bleeding episodes associated with differing antithrombotic strategies in patients undergoing transcatheter aortic valve replacement (TAVR) with concomitant atrial fibrillation (AF).BACKGROUND Guidelines recommend antiplatelet therapy (APT) post-TAVR to reduce the risk of stroke. However, data on the efficacy and safety of this recommendation in the setting of a concomitant indication for oral anticoagulation (due to atrial fibrillation [AF]) with a vitamin K antagonist (VKA) are scarce.METHODS A multicenter evaluation comprising 621 patients with AF undergoing TAVR was undertaken. Post-TAVR prescriptions were used to determine the antithrombotic regimen used according to the following 2 groups: monotherapy (MT) with VKA (n = 101) or multiple antithrombotic therapy (MAT) with VKA plus 1 or 2 antiplatelet agents (aspirin or clopidogrel; n = 520). Endpoint definitions were in accordance with Valve Academic Research Consortium-2 criteria. The rate of stroke, major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death), major or life-threatening bleeding events, and death were assessed by a Cox multivariate model regression survival analysis according to the antithrombotic regime used.RESULTS During a median follow-up of 13 months (interquartile range: 3 to 31 months) there were no differences between groups in the rate of stroke (MT: 5%, MAT: 5.2%; adjusted hazard ratio [HR]: 1.25; 95% confidence interval [CI]: 0.45 to 3.48; p = 0.67), major adverse cardiovascular events (MT: 13.9%, MAT: 16.3%; adjusted HR: 1.33; 95% CI: 0.75 to 2.36; p = 0.33), and death (MT 22.8%, MAT: 19.2%; adjusted HR: 0.93; 95% CI: 0.58 to 1.50; p = 0.76). A higher risk of major or life-threatening bleeding was found in the MAT group (MT: 14.9%, MAT: 24.4%; adjusted HR: 1.85; 95% CI: 1.05 to 3.28; p = 0.04). These results remained similar when patients receiving VKA plus only 1 antiplatelet agent (n = 463) were evaluated.CONCLUSIONS In TAVR recipients prescribed VKA therapy for AF, concomitant antiplatelet therapy use appears not to reduce the incidence of stroke, major adverse cardiovascular events, or death, while increasing the risk of major or life-threatening bleeding. (C) 2016 by the American College of Cardiology Foundation.

This study sought to evaluate the outcomes of the early experience of transcatheter mitral valve replacement (TMVR) with balloon-expandable valves in patients with severe mitral annular calcification (MAC) and reports the first large series from a multicenter global registry.The risk of surgical mitral valve replacement in patients with severe MAC is high. There are isolated reports of successful TMVR with balloon-expandable valves in this patient population.We performed a multicenter retrospective review of clinical outcomes of patients with severe MAC undergoing TMVR.From September 2012 to July of 2015, 64 patients in 32 centers underwent TMVR with compassionate use of balloon-expandable valves. Mean age was 73 ± 13 years, 66% were female, and mean Society of Thoracic Surgeons score was 14.4 ± 9.5%. The mean mitral gradient was 11.45 ± 4.4 mm Hg and the mean mitral area was 1.18 ± 0.5 cm(2). SAPIEN valves (Edwards Lifesciences, Irvine, California) were used in 7.8%, SAPIEN XT in 59.4%, SAPIEN 3 in 28.1%, and Inovare (Braile Biomedica, Brazil) in 4.7%. Access was transatrial in 15.6%, transapical in 43.8%, and transseptal in 40.6%. Technical success according to Mitral Valve Academic Research Consortium criteria was achieved in 46 (72%) patients, primarily limited by the need for a second valve in 11 (17.2%). Six (9.3%) had left ventricular tract obstruction with hemodynamic compromise. Mean mitral gradient post-procedure was 4 ± 2.2 mm Hg, paravalvular regurgitation was mild or absent in all. Thirty-day all-cause mortality was 29.7% (cardiovascular = 12.5% and noncardiac = 17.2%); 84% of the survivors with follow-up data available were in New York Heart Association functional class I or II at 30 days (n = 25).TMVR with balloon-expandable valves in patients with severe MAC is feasible but may be associated with significant adverse events. This strategy might be an alternative for selected high-risk patients with limited treatment options.

Background: Portico valve is a second-generation self-expanding repositionable system with a nitinol stent frame and bovine pericardial leaflets, which is increasingly utilized for transcatheter aortic valve replacement (TAVR) . In this report, we describe the procedural and early clinical results from an international multicenter registry of Portico implantation in patients with degenerated aortic bioprosthesis (Portico ViV). Methodology: Baseline data and outcomes were collected on standard case report forms and by the Valve-in-Valve International Data network from 14 centers across three continents. Procedural endpoints included implantation success and coronary obstruction. Clinical endpoints included death, myocardial infarction (MI), stroke, major bleeding at 30 days as defined by Valve Academic Research consortium II (VARCII). Result: 45 patients undergoing Portico ViV were included in analysis. The mean age was 79± 7 years with STS (mortality) score of 7±4. These procedures had mainly utilized peripheral arterial access (93%), with transesophageal echocardiogram guidance (60%) for treatment of surgical valve label size ≤21, >21- Conclusion: Results from this international multicenter registry show that Portico offers a safe and effective treatment of failed surgical bioprosthesis with an added advantage of device retrievability, resulting in low incidence of malpositioning and coronary obstruction. Additional studies and comparison with other transcatheter devices should further determine the hemodynamic and clinical performance of this device for selection of optimal treatment of high risk patients with failed surgical bioprostheses

Trans-catheter intervention to close a patent foramen ovale (PFO) is an accepted therapy to patients presenting with a cryptogenic stroke that is thought to be due to paradoxical embolization. Effectiveness of such an intervention is verified by agitated saline contrast (ASC) injection during

Transradial approach (TR) for coronary angiography and intervention (CA/PCI) is shown to offer significant advantages compared to transfemoral approach (TF) in general population. However, limited information is available for the safety and efficacy of TR in the elderly. A comprehensive literature

Background Cardiogenic shock is the leading cause of death in patients with acute myocardial infarction. Despite significant advancements in health technology and research, hospital mortality approaches 50%. The intra-aortic balloon pump is a mechanical hemodynamic assist device that has been used for over 40 years in the management of patients with cardiogenic shock. A recent randomized trial suggests that the use of intra-aortic balloon pumps does not reduce mortality in patients with ischemic cardiogenic shock. Methods We plan to search MEDLINE, EMBASE, and the Cochrane Trial Registry for potentially eligible randomized trials that compare the use of intra-aortic balloon pump with no mechanical device support in patients with cardiogenic shock. No date, language or journal limitations will be applied. Two reviewers will independently screen and identify eligible studies using predefined eligibility criteria. Data abstraction will be done independently and in duplicate. We plan to use RevMan software to generate pooled estimates across included studies, using the previously published method of DerSimonian and Laird. We will report pooled estimates as risk ratios with 95% confidence intervals for binary outcomes, and as mean differences with 95% confidence intervals for continuous outcomes. We will assess the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Discussion The aim of this systematic review and meta-analysis is to summarize the available evidence on the efficacy of the intra-aortic balloon pump in cardiogenic shock. Systematic review registration: PROSPERO CRD42014007056.

Partial anomalous pulmonary venous connection (PAPVC) is a relatively uncommon congenital heart defect that is usually associated with either sinus venosus or secundum atrial septal defect (ASD). Patients with an isolated single PAPVC are usually asymptomatic; whereas, co-existence of sinus venosus

Optimal transcatheter heart valve (THV) sizing is crucial to optimize procedural outcomes. Larger THV oversizing is shown to decrease paravalvular leakage post transcatheter aortic valve replacement but its role in Valve in Valve implantation (ViV) is not well established. For each surgical type

Trans-catheter closure of atrial septal defects using multiple devices is techincally challenging. Overall complication rates including device erosion and new-onset pericardial effusion seems to be higher in comparison to patients treated with single device. We sought to evaluate intermediate and

Transcatheter aortic valve replacement (TAVR) is technically challenging, requiring significant training to optimize outcomes. Here, we investigate the learning curve for TAVR in a prospective multicenter registry. A total of 1953 patients undergoing TAVR at 8 sites from April 2009 to July 2014

Background: Cardiogenic shock is the leading cause of death in patients with acute myocardial infarction. Despite significant advancements in health technology and research, hospital mortality approaches 50%. The intra-aortic balloon pump is a mechanical hemodynamic assist device that has been used for over 40 years in the management of patients with cardiogenic shock. A recent randomized trial suggests that the use of intra-aortic balloon pumps does not reduce mortality in patients with ischemic cardiogenic shock. Methods: We plan to search MEDLINE, EMBASE, and the Cochrane Trial Registry for potentially eligible randomized trials that compare the use of intra-aortic balloon pump with no mechanical device support in patients with cardiogenic shock. No date, language or journal limitations will be applied. Two reviewers will independently screen and identify eligible studies using predefined eligibility criteria. Data abstraction will be done independently and in duplicate. We plan to use RevMan software to generate pooled estimates across included studies, using the previously published method of DerSimonian and Laird. We will report pooled estimates as risk ratios with 95% confidence intervals for binary outcomes, and as mean differences with 95% confidence intervals for continuous outcomes. We will assess the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Discussion: The aim of this systematic review and meta-analysis is to summarize the available evidence on the efficacy of the intra-aortic balloon pump in cardiogenic shock. Systematic review registration: PROSPERO CRD42014007056.

BACKGROUND: Transradial approach (TR) for coronary angiography and intervention (CA/PCI) is shown to offer significant advantages compared to the transfemoral approach (TF) in general population. However, limited information is available for the safety and efficacy of TR in the elderly, a population with higher rate of subclavian artery calcification and tortousity. METHODS: A comprehensive literature search of studies comparing TR and TF in the elderly (mean age 82year) was performed. Mantel-Haenszel random effects model was used to compute odds ratio (OR) with 95% confidence intervals (CI). The primary endpoint of this study was composite of vascular complications. The secondary endpoints included access site cross over, myocardial infarction (MI), stroke and in-hospital mortality. RESULTS: A total of 235 studies were reviewed and 9 included in the final analysis. Clinical outcomes of 2315 patients (2 randomized and 7 observational studies) were compared between TR (995 patients, 43%) and TF (1320 patients, 57%). Compared to TF, TR resulted in significant reduction of composite vascular endpoints (4.4 vs. 12.3 %, OR 0.20, p < 0.00001), and individual subtypes, hematoma (2.7 vs. 9.2%, OR 0.25, p

Background: Portico valve is a second-generation self-expanding repositionable system with a nitinol stent frame and bovine pericardial leaflets, which is increasingly utilized for transcatheter ao...

Portico® (St. Jude Medical) and CoreValve™ (Medtronic) are both nitinol based self-expanding transcatheter heart valves with unique features enabling device retrievability for Portico and supra annular valve position for CoreValve systems. In this study, we sought to investigate the effect of the