Prevalence, predictors, and outcomes of patient prosthesis mismatch in women undergoing TAVI for severe aortic stenosis: Insights from the WIN-TAVI registry.

OBJECTIVE: To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS). BACKGROUND: Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date. METHODS: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multicenter registry of women undergoing TAVR for severe symptomatic AS. Two hundred and fifty patients with detailed periprocedural and follow-up echocardiographic investigations were included in the WIN-TAVI echocardiographic sub-study. PPM was defined as per European guidelines stratified by the presence of obesity. RESULTS: The incidence of PPM in our population was 32.8%. Patients with PPM had significantly higher BMI (27.4 ± 6.1 vs. 25.2 ± 5.0, p = .002), smaller sized valves implanted (percentage of TAVI ≤23 mm 61% vs. 29.2%, PPM vs. no PPM, p < .001) and were more often treated with balloon expandable valves (48.3 vs. 32.5%, p < .001) rather than self expanding ones (26.3 vs. 52.8%, <.001). BMI (OR = 1.08; 95%CI 1.02-1.14, p = .011) and valve size ≤23 mm (OR = 3.00 95%CI 1.14-7.94, p = .027) were the only independent predictors of PPM. There was no significant interaction between valve size and valve type (p = .203). No significant differences were observed in 1-year mortality or major adverse cardiovascular events. CONCLUSIONS: PPM in females undergoing TAVI occurs in one third of patients. BMI and valve size ≤23 mm are independent predictors. Larger registries are required to determine the impact of PPM on future clinical outcomes.

Genetic variations in the alanine-glyoxylate aminotransferase 2 (AGXT2) gene and dimethylarginines levels in rheumatoid arthritis.

Rheumatoid arthritis (RA) is associated with high rates of cardiovascular events mainly due to coronary and cerebrovascular atherosclerotic disease. Asymmetric (ADMA) and symmetric (SDMA) dimethylarginines are endogenous inhibitors of nitric oxide synthase and have been repeatedly linked with adverse cardiovascular outcomes in the general population and various disease settings. Alanine-glyoxylate aminotransferase 2 (AGTX2) is considered an alternative metabolic pathway contributing to the clearance of dimethylarginines in humans. The aim of the current study was to investigate the effect of specific AGXT-2 gene polymorphisms on circulating levels of ADMA or SDMA in patients with RA. Serum ADMA and SDMA levels were measured in 201 individuals with RA [median age: 67 years (IQR: 59-73), 155 females]. Two single nucleotide polymorphisms (SNPs) in the AGXT-2 gene-rs37369 and rs28305-were genotyped. Distributions of SDMA and ADMA were skewed, hence comparisons across the gene polymorphisms were performed using Kruskal-Wallis tests, and summarized using medians and interquartile ranges. Univariable analysis did not demonstrate a significant difference in the levels of SDMA or ADMA amongst the different genotypic groups of either rs37369AGXT2 (p = 0.800, 0.977) or rs28305AGXT2 (p = 0.463, 0.634). In multivariable analyses, ADMA levels were found to be significantly associated with erythrocyte sedimentation rate and estimated glomerular filtration rate, whilst SDMA levels were significantly associated with estimated glomerular filtration rate and quantitative insulin sensitivity check index. After adjustments for these factors, the relationship between the AGXT2 gene variants and both ADMA and SDMA remained non-significant. Our study in a well-characterized RA population did not show an association between serum concentrations of dimethylarginines and genetic variants of the AGXT2 gene.

Echocardiographic assessment in patients with chronic kidney disease: Current update.

Patients with chronic kidney disease (CKD) carry a high cardiovascular risk. An abundance of evidence has emerged in recent years establishing minor reductions in estimated glomerular filtration rate as an independent risk factor for cardiovascular mortality. Additionally, cardiac changes, such as left ventricular hypertrophy and impaired left ventricular systolic function, have been associated with an unfavorable prognosis. Despite the significant prevalence of underlying cardiac abnormalities, symptoms may not manifest in many patients with CKD. A range of available and emerging echocardiographic modalities may assist with diagnosing heart disease in CKD. Furthermore, some of these emerging techniques can give an important insight into the pathophysiology of subclinical dysfunction in CKD. This review discusses how current and emerging echocardiographic modalities such as speckle tracking echocardiography and 3D echocardiography might help cardiologists in providing important information to help with diagnosis and risk stratification of cardiac-related morbidity and mortality in patients with renal disease, as well applicability of these tools to current clinical practice.

Transarterial Endoleak Closure After Endovascular Thoracoabdominal Aneurysm Repair: When the "Sandwich" Goes Wrong.

PURPOSE: To describe the use of vascular plugs to close a complex type Ib endoleak following the sandwich procedure used in conjunction with endovascular thoracoabdominal aortic aneurysm (TAAA) repair. CASE REPORT: A 59-year-old man with a 6.5-mm TAAA was treated with initial deployment proximally of 2 Zenith TX2 stent-grafts. In preparation for the sandwich technique to preserve flow to the celiac trunk, a 10×100-mm Viabahn covered stent was delivered from a brachial access into the celiac trunk unprotected by the sheath of the introducer. The trigger wire system became snagged on the struts of the distal aortic stent-graft; when the wire was pulled, the proximal end of the Viabahn migrated outside the aortic stent-graft, which migrated upward. The main body extension intended for the aortic component of the sandwich technique was deployed close to the distal end of the aneurysm sac, but a large type Ib endoleak formed in the gutter between the Viabahn, aortic extension, and sac wall. The leak perfused the celiac trunk, and the procedure was terminated. Increasing sac size on 3-month imaging prompted closure of the leak with 2 type II Amplatzer vascular plugs aiming to occlude the endoleak outflow into the Viabahn and the endoleak outflow at the site of the gutter. Imaging follow-up at 6 months demonstrated successful exclusion of the TAAA with no residual endoleak and excellent perfusion of the celiac trunk. CONCLUSION: Transarterial treatment of complex endoleaks is feasible when preceded by meticulous imaging and detailed preprocedural planning.

Successful Treatment of Very Early Thrombosis of SAPIEN 3 Valve with Direct Oral Anticoagulant Therapy.

Thrombosis of transcatheter aortic valve implantation (TAVI) is an uncommon complication that commonly occurs weeks to months following the procedure. Herein are described the details of a patient who presented with a recurrence of symptoms days after intervention with a bioprosthesis thrombosis that was successfully treated with direct oral anticoagulant (DOAC) therapy and resulted in hemodynamic improvement and resolution of symptoms. Whilst a previous trial of DOAC therapy with mechanical valves was stopped due to elevated events in comparison to warfarin, a TAVI valve may be different, and the rapid onset of action and reduced bleeding risk may be beneficial in this patient group.

The Impact of Gender on Outcomes Following Transcatheter Aortic Valve Implantation: True Effect or Bias?

Transcatheter aortic valve implantation (TAVI) is currently the treatment of choice for patients with severe aortic stenosis (AS) who are unsuitable for surgical aortic valve replacement (SAVR), and is an acceptable alternative for those at high and intermediate surgical risk. In published TAVI registries and meta-analyses, whilst women are significantly older they present with fewer comorbidities compared to men (including coronary artery disease, peripheral vascular disease, diabetes and chronic obstructive pulmonary disease). In response to chronic pressure overload from AS, women have been shown to develop greater levels of left ventricular hypertrophy than men, as well as having a greater preservation of LV ejection fraction (LVEF) and less fibrosis. Following aortic valve replacement, women have been shown to have a faster regression of myocardial hypertrophy, with a significant improvement in LVEF. Following TAVI, female gender seems to be associated with a significantly lower one-year mortality. In the current viewpoint, it is discussed whether these findings reflect a true differential treatment response to TAVI among women, or simply the higher comorbidity burden among males undergoing TAVI.

Left ventricular twist mechanics and its relation with aortic stiffness in chronic kidney disease patients without overt cardiovascular disease.

BACKGROUND: Recent studies hypothesized left ventricular (LV) twist as a potential biomarker for evaluation of sub clinical myocardial disease, however its relationship with aortic stiffness has yet to be investigated. Chronic kidney disease (CKD) has been identified as a risk factor for both myocardial and arterial disease. As such we sought to explore the relationship between aortic stiffness and LV twist in CKD patients without known cardiovascular disease (CVD). METHODS: In this prospective, observational study we enrolled 106 CKD patients (Stages 1 to 5) with normal LVEF as assessed by conventional echocardiography. Aortic stiffness was measured using aortic pulse wave velocity (aPWV). We defined increased aPWV as ≥10 m/s. LV Twist was measured using two-dimensional speckle tracking echocardiography. RESULTS: Patients with increased aPWV had higher LV twist (p = 0.002) but similar LVEF (p = 0.486). Aortic PWV correlated crudely with age (p < 0.001), the presence of diabetes (p < 0.001), hypertension (p < 0.001), eGFR (p < 0.001), LVMI (p = 0.01), e/e' (p < 0.001) and LV twist (p = 0.003). In multivariable analyses after adjusting for age, gender, cardiovascular risk factors and hypertensive medication, aPWV was independently associated with LV twist (ß = 0.163, p = 0.025). CONCLUSIONS: Aortic stiffness independently associates with LV Twist in asymptomatic CKD patients. These findings suggest a close interaction between LV twist mechanics and arterial remodeling even before CVD becomes clinically relevant.

Comparison of 2-year outcomes between zotarolimus-eluting and everolimus-eluting new-generation cobalt-chromium alloy stents in real-world diabetic patients.

BACKGROUND: To date, it remains unknown whether different types of new-generation drug-eluting stents have a differential impact on long-term outcomes in diabetic patients. METHODS AND RESULTS: In this historical cohort study (two Italian centers), we analyzed 400 diabetic patients with 553 coronary lesions treated with new-generation CoCr zotarolimus-eluting stents (R-ZES: 136 patients, 196 lesions) or everolimus-eluting stents (EES: 264 patients, 357 lesions) between October 2006 and August 2012. Primary endpoint was the occurrence of major adverse cardiac events (MACE) over a 2-year follow-up period. MACE was defined as all-cause mortality, any myocardial infarction (MI) and/or target lesion revascularization (TLR). Multivessel revascularization, intervention for restenotic lesion and use of intravascular ultrasound were significantly higher in the R-ZES group, whereas small stent (≤2.5 mm) deployment was significantly higher in the EES group. At 2-year follow-up, there was no significant difference in occurrence of MACE (R-ZES vs EES: 22.8% vs 18.9%, P = 0.39). Similarly, no significant differences were observed in the composite endpoint of all-cause mortality/MI (10.0% vs 10.3%, P = 0.86) or TLR (12.4% vs 7.4%, P = 0.11). Adjustment for confounders and baseline propensity-score matching did not alter the aforementioned associations. CONCLUSION: After 2 years of follow up similar outcomes (MACE, all-cause mortality/MI, TLR) were observed in real-world diabetic patients, including those with complex lesions and patient characteristics, treated with R-ZES and EES.

Clinical outcomes of real-world patients treated with an amphilimus polymer-free stent versus new generation everolimus-eluting stents.

OBJECTIVES/BACKGROUND: To compare the 1-year clinical outcomes after implantation of the amphilimus, polymer-free stent (Cre8) versus new generation everolimus-eluting stents (EESs) in a real-world patient registry. METHODS: A total of 187 consecutive patients treated with Cre8 between January 2011 and August 2013 in four Italian centers were included. These were propensity matched with 150 patients treated with new generation EES during the same period. Primary outcome was 1-year major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, and target vessel revascularization. RESULTS: Both groups had similar baseline characteristics, including diabetes (28% Cre8 vs. 27.3% EES, P = 0.972) and previous percutaneous coronary intervention (56% Cre8 vs. 58% EES, P = 0.726). There was a higher prevalence of B2/C lesions in the EES group (70.1% vs. 83.8%, P < 0.001). Total stent length per patient was similar. There were no significant differences in 1-year estimated MACE (7.4% Cre8 vs. 10.2% EES, P = 0.261), all-cause mortality (1.3% Cre8 vs. 1.4% EES, P = 0.823), target vessel revascularization (5.2% Cre8 vs. 8.8% EES, P = 0.169), and target lesion revascularization (3% Cre8 vs. 7.4% EES, P = 0.108) between the two groups. When adjusting for differences in baseline lesion characteristics, hazard ratio(Cre8/EES) for MACE was not significantly different between the two groups (0.75, 95% confidence interval 0.37-1.53, P(noninferiority) = 0.001, P(superiority) = 0.432). In patients with diabetes (Cre8, n = 42; EEE, n = 41), 1-year target lesion revascularization was 2.5% in the Cre8 group versus 14.6% in the EES group (P = 0.056). CONCLUSIONS: In a "real-world" patient registry, the Cre8 stent is associated with noninferior 1-year MACE rates compared with that of new generation EES. Trends of superior efficacy in patients with diabetes treated with Cre8 require further investigation.

First generation versus new generation drug-eluting stents for the treatment of ostial/midshaft lesions in unprotected left main coronary artery: the Milan and New-Tokyo (MITO) registry.

OBJECTIVES: To compare the clinical outcomes following unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) of ostial/midshaft lesions between first and new generation drug-eluting stents (DES). BACKGROUND: Clinical outcomes after treatment of ostial/midshaft lesions in ULMCA with first generation DES were favorable. However, to date, data regarding treatment for those lesion subsets with new generation DES have not been reported. METHODS: A total of 219 patients with ostial/midshaft lesions in ULMCA treated with first (n = 139) or new generation DES (n = 80) were analyzed. RESULTS: There was a higher prevalence of IVUS use (35.2% vs. 50.0%, P = 0.032) and postdilation (70.5% vs. 93.8%, P < 0.001) with larger maximum balloon diameter (3.81 ± 0.45 vs. 4.08 ± 0.44, P < 0.001) in the new generation DES group. At a median follow-up period of 730 days, there were no significant differences in the propensity-score adjusted analyses, for major adverse cardiac events (MACE) defined as composite endpoint of all-cause death, myocardial infarction, and target vessel revascularization (hazard ratio (HR) [new vs. first generation DES]: 1.22; 95% confidence interval (CI): 0.64-2.31; P = 0.549). Of note, target lesion revascularization rates at 2-years were only 0.9% and 2.7%, for first and new generation DES groups, respectively (P = 0.339). On multivariable analysis, SYNTAX score (HR: 1.06; 95% CI: 1.02-1.11, P = 0.006) and European System for Cardiac Operative Risk Evaluation (HR: 1.14; 95% CI: 1.00-1.31, P = 0.051) were independent predictors for MACE. CONCLUSIONS: This study suggests that new generation DES for ostial/midshaft lesions in ULMCA are associated with favorable clinical outcomes, similar to those observed with first generation DES.

Early Outcomes With Direct Flow Medical Versus First-Generation Transcatheter Aortic Valve Devices: A Single-Center Propensity-Matched Analysis.

OBJECTIVES: To compare early outcomes between Direct Flow Medical (DFM) and 1(st) -generation transcatheter aortic valve replacement (TAVR) devices. BACKGROUND: The effectiveness of new-generation TAVR devices compared with earlier generations is unclear. METHODS AND RESULTS: Overall, 496 patients treated between November 2007 and March 2014 were included: 44 (8.7%) treated with DFM, 179 (36.9%) with Medtronic CoreValve (MCV) and 273 (54.4%) with Edwards Sapien / Sapien XT (SXT) valve. Because of differences in baseline characteristics, propensity-score matching among patients treated in the same time span (March 2012-March 2014) was performed. The primary objective was the VARC-2 device success composite endpoint. Propensity-score matching identified 41 patients in each group. A higher device success composite endpoint was observed in DFM (DFM 97.6% vs. MCV 65.9% vs. SXT 92.7%; P < 0.001). This was attributed to a significantly lower incidence of moderate-to-severe post-procedural aortic regurgitation (AR; 2.4% vs. 22% vs. 7.3%; P < 0.001), lower rate of valve embolization (0% vs. 7.3% vs. 0%; 0.041) and need for a 2nd valve implantation (0% vs. 7.3% vs. 0%; P = 0.041). CONCLUSIONS: DFM was associated with higher rates of device success and a lower incidence of post-procedural AR. New generation devices appear to address several of the limitations of earlier generation devices.

Physiological right ventricular adaptation in elite athletes of African and Afro-Caribbean origin.

BACKGROUND: Regular, intensive exercise results in physiological biventricular cardiac adaptation. Ethnicity is an established determinant of left ventricular remodeling; black athletes (BAs) exhibit more profound LV hypertrophy than white athletes (WAs). Right ventricular (RV) remodeling has not been characterized in BAs, although the issue is pertinent because BAs commonly exhibit ECG anomalies that resemble arrhythmogenic RV cardiomyopathy. METHODS AND RESULTS: Between 2006 and 2012, 300 consecutive BAs (n=243 males) from 25 sporting disciplines were evaluated by use of ECG and echocardiography. Results were compared with 375 WAs and 153 sedentary control subjects (n=69 blacks). There were no ethnic differences between RV parameters in control subjects. Both BAs and WAs exhibited greater RV dimensions than control subjects. RV dimensions were marginally smaller in BAs than in WAs (proximal outflow tract, 30.9±5.5 versus 32.8±5.3 mm, P<0.001; longitudinal dimension, 86.6±9.5 versus 89.8±9.6 mm, P<0.001), although only 2.3% of variation was attributable to ethnicity. RV enlargement compatible with diagnostic criteria for arrhythmogenic RV cardiomyopathy was frequently observed (proximal outflow tract ≥32 mm; 45.0% of BAs, 58.5% of WAs). Anterior T-wave inversion was present in 14.3% of BAs versus 3.7% of WAs (P<0.001). Marked RV enlargement with concomitant anterior T-wave inversion was observed in 3.0% of BAs versus 0.3% of WAs (P=0.005). Further investigation did not diagnose arrhythmogenic RV cardiomyopathy in any athlete. CONCLUSIONS: Physiological RV enlargement is commonly observed in both black and white athletes. The impact of ethnicity is minimal, which obviates the need for race-specific RV reference values. However, in the context of frequent ECG repolarization anomalies in BAs, the potential for erroneous diagnosis of arrhythmogenic RV cardiomyopathy is considerably greater in this ethnic group.

Prolonged QTc interval predicts all-cause mortality in patients with rheumatoid arthritis: an association driven by high inflammatory burden.

OBJECTIVE: RA associates with an increased rate of sudden cardiac death (SCD). A prolonged QTc interval has been associated with arrhythmogenic and SCD in patients with long QT syndrome. Despite the previously reported contemporary association of CRP with SCD, thus far no studies have examined the association of QTc with mortality in RA, a condition characterized by high inflammatory burden. The aim of this study was to examine the role of electrocardiography (QT corrected interval) in predicting all-cause mortality in patients with RA who have an increased rate of SCD and a high inflammatory burden. METHODS: Three hundred and fifty-seven RA patients with detailed baseline clinical characterization and 12-lead ECGs were followed up for a mean of 73.0 (S.D. 18.3) months. Linear and Cox regression analyses were used to identify variables that associate with QTc and examine its association with all-cause mortality. RESULTS: The patients' mean age was 60.6 (S.D. 12.0) years, 267 (74.8%) were females and 54 (15.1%) died during the follow-up period. Age (ß = 0.231, P < 0.001), gender (ß = 0.137, P = 0.008) and CRP (ß = 0.144, P = 0.006) associated independently with QTc in RA patients. The crude hazard ratio (HR) for total mortality per 50-ms increase in QTc was 2.17 (95% CI 1.21, 3.90). This association remained significant [HR = 2.18 (95% CI 1.09, 4.35)] after adjustment for identified confounders (cardiovascular and RA specific), but was lost [HR = 1.73 (95% CI 0.83, 3.62)] when CRP was included in the model. CONCLUSION: A 50-ms increase in QTc interval associates with a doubling of the hazard for all-cause mortality in patients with RA. The observed contemporary association of QTc with CRP levels indicates a potentially hazardous interplay between inflammation and arrhythmogenesis. Future studies are needed to confirm the above findings and explore underlying mechanisms.

Predictors of left ventricular ejection fraction in high-risk percutaneous coronary interventions.

Revascularization completeness after percutaneous coronary intervention (PCI) is associated with improved long-term outcomes. Mechanical circulatory support [intra-aortic balloon pump (IABP) or Impella] is used during high-risk PCI (HR-PCI) to enhance peri-procedural safety and achieve more complete revascularization. The relationship between revascularization completeness [post-PCI residual SYNTAX Score (rSS)] and left ventricular ejection fraction (LVEF) in HR-PCI has not been established. We investigated LVEF predictors at 90 days post-PCI with Impella or IABP support. Individual patient data (IPD) were analyzed from PROTECT II (NCT00562016) in the base case. IPD from PROTECT II and RESTORE-EF (NCT04648306) were naïvely pooled in the sensitivity analysis. Using complete cases only, linear regression was used to explore the predictors of LVEF at 90 days post-PCI. Models were refined using stepwise selection based on Akaike Information Criterion and included: treatment group (Impella, IABP), baseline characteristics [age, gender, race, New York Heart Association Functional Classification, LVEF, SYNTAX Score (SS)], and rSS. Impella treatment and higher baseline LVEF were significant predictors of LVEF improvement at 90 days post-PCI (p ≤ 0.05), and a lower rSS contributed to the model (p = 0.082). In the sensitivity analysis, Impella treatment, higher baseline LVEF, and lower rSS were significant predictors of LVEF improvement at 90 days (p ≤ 0.05), and SS pre-PCI contributed to the model (p = 0.070). Higher baseline LVEF, higher SS pre-PCI, lower rSS (i.e. completeness of revascularization), and Impella treatment were predictors of post-PCI LVEF improvement. The findings suggest potential mechanisms of Impella include improving the extent and quality of revascularization, and intraprocedural ventricular unloading.

Pressure-Controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction: The PiCSO-AMI-I Trial.

BACKGROUND: Primary percutaneous coronary intervention (pPCI) has improved clinical outcomes in patients with ST-segment-elevation myocardial infarction. However, as many as 50% of patients still have suboptimal myocardial reperfusion and experience extensive myocardial necrosis. The PiCSO-AMI-I trial (Pressure-Controlled Intermittent Coronary Sinus Occlusion-Acute Myocardial Infarction-I) evaluated whether PiCSO therapy can further reduce myocardial infarct size (IS) in patients undergoing pPCI. METHODS: Patients with anterior ST-segment-elevation myocardial infarction and Thrombolysis in Myocardial Infarction flow 0-1 were randomized at 16 European centers to PiCSO-assisted pPCI or conventional pPCI. The PiCSO Impulse Catheter (8Fr balloon-tipped catheter) was inserted via femoral venous access after antegrade flow restoration of the culprit vessel and before proceeding with stenting. The primary end point was the difference in IS (expressed as a percentage of left ventricular mass) at 5 days by cardiac magnetic resonance. Secondary end points were the extent of microvascular obstruction and intramyocardial hemorrhage at 5 days and IS at 6 months. RESULTS: Among 145 randomized patients, 72 received PiCSO-assisted pPCI and 73 conventional pPCI. No differences were observed in IS at 5 days (27.2%±12.4% versus 28.3%±11.45%; P=0.59) and 6 months (19.2%±10.1% versus 18.8%±7.7%; P=0.83), nor were differences between PiCSO-treated and control patients noted in terms of the occurrence of microvascular obstruction (67.2% versus 64.6%; P=0.85) or intramyocardial hemorrhage (55.7% versus 60%; P=0.72). The study was prematurely discontinued by the sponsor with no further clinical follow-up beyond 6 months. However, up to 6 months of PiCSO use appeared safe with no device-related adverse events. CONCLUSIONS: In this prematurely discontinued randomized trial, PiCSO therapy as an adjunct to pPCI did not reduce IS when compared with conventional pPCI in patients with anterior ST-segment-elevation myocardial infarction. PiCSO use was associated with increased procedural time and contrast but no increase in adverse events up to 6 months. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03625869.

Percutaneous Left Ventricular Unloading During High-Risk Coronary Intervention: Rationale and Design of the CHIP-BCIS3 Randomized Controlled Trial.

INTRODUCTION: Percutaneous coronary intervention for complex coronary disease is associated with a high risk of cardiogenic shock. This can cause harm and limit the quality of revascularization achieved, especially when left ventricular function is impaired at the outset. Elective percutaneous left ventricular unloading is increasingly used to mitigate adverse events in patients undergoing high-risk percutaneous coronary intervention, but this strategy has fiscal and clinical costs and is not supported by robust evidence. METHODS: CHIP-BCIS3 (Controlled Trial of High-Risk Coronary Intervention With Percutaneous Left Ventricular Unloading) is a prospective, multicenter, open-label randomized controlled trial that aims to determine whether a strategy of elective percutaneous left ventricular unloading is superior to standard care (no planned mechanical circulatory support) in patients undergoing nonemergent high-risk percutaneous coronary intervention. Patients are eligible for recruitment if they have severe left ventricular systolic dysfunction, extensive coronary artery disease, and are due to undergo complex percutaneous coronary intervention (to the left main stem with calcium modification or to a chronic total occlusion with a retrograde approach). Cardiogenic shock and acute ST-segment-elevation myocardial infarction are exclusions. The primary outcome is a hierarchical composite of all-cause death, stroke, spontaneous myocardial infarction, cardiovascular hospitalization, and periprocedural myocardial infarction, analyzed using the win ratio. Secondary outcomes include completeness of revascularization, major bleeding, vascular complications, health economic analyses, and health-related quality of life. A sample size of 250 patients will have in excess of 80% power to detect a hazard ratio of 0.62 at a minimum of 12 months, assuming 150 patients experience an event across all follow-up. CONCLUSIONS: To date, 169 patients have been recruited from 21 National Health Service hospitals in the United Kingdom, with recruitment expected to complete in 2024. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05003817.

Iatrogenic communications between aortic root and right ventricle/left atrium after transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative, less invasive treatment option for patients with severe symptomatic aortic stenosis, who are high-risk for conventional surgical aortic valve replacement, due to co-morbidities. In addition to a 30-day 10% mortality risk there is a recognized range of complications, which commonly relate to vascular access trauma, paravalvular aortic regurgitation, and cerebrovascular events. In the following case reports, we discuss two previously unreported complications of TAVR: (i) an iatrogenic communication between the aortic root and the right ventricle and (ii) an iatrogenic communication between the aortic root and the left atrium. Informed written consent was obtained from both patients.

Management of Bleeding and Hemolysis During Percutaneous Microaxial Flow Pump Support: A Practical Approach.

Percutaneous ventricular assist devices (pVADs) are increasingly being used because of improved experience and availability. The Impella (Abiomed), a percutaneous microaxial, continuous-flow, short-term ventricular assist device, requires meticulous postimplantation management to avoid the 2 most frequent complications, namely, bleeding and hemolysis. A standardized approach to the prevention, detection, and treatment of these complications is mandatory to improve outcomes. The risk for hemolysis is mostly influenced by pump instability, resulting from patient- or device-related factors. Upfront echocardiographic assessment, frequent monitoring, and prompt intervention are essential. The precarious hemostatic balance during pVAD support results from the combination of a procoagulant state, due to critical illness and contact pathway activation, together with a variety of factors aggravating bleeding risk. Preventive strategies and appropriate management, adapted to the impact of the bleeding, are crucial. This review offers a guide to physicians to tackle these device-related complications in this critically ill pVAD-supported patient population.

The prevalence, distribution, and clinical outcomes of electrocardiographic repolarization patterns in male athletes of African/Afro-Caribbean origin.

AIMS: Athletic training in male black athletes (BAs) is associated with marked ECG repolarization changes that overlap with hypertrophic cardiomyopathy (HCM). Differentiating between the two entities is prudent since BAs exhibit a higher prevalence of exercise-related sudden death from HCM compared with white athletes (WAs). METHODS AND RESULTS: Between 1996 and 2010, 904 BAs underwent serial cardiac evaluations including ECG and echocardiography. Athletes exhibiting T-wave inversions were investigated further for HCM. Results were compared with 1819 WAs, 119 black controls (BCs), and 52 black HCM patients. Athletes were followed up for 69.7 ± 29.6 months. T-wave inversions were present in 82.7% HCM patients, 22.8% BAs, 10.1% BCs, and 3.7% WAs. In athletes, the major determinant of T-wave inversions was black ethnicity. T-wave inversions in BAs (12.7%) were predominantly confined to contiguous anterior leads (V1-V4). Only 4.1% of BAs exhibited T-wave inversions in the lateral leads. In contrast, both BCs and HCM patients exhibited lower prevalence of T-wave inversions in leads V1-V4 (4.2 and 3.8%, respectively) with most T-wave inversions in HCM patients (76.9%) involving the lateral leads. During follow-up one BA survived cardiac arrest and two athletes (one BA, one WA) were diagnosed with HCM. All three exhibited T-wave inversions in the lateral leads. CONCLUSIONS: T-wave inversions in leads V1-V4 appear to represent an ethnic variant of 'athlete's heart'. Conversely, T-wave inversions in the lateral leads may represent the initial expression of underlying cardiomyopathy and merit further evaluation and regular surveillance.

Rheumatoid arthritis susceptibility genes associate with lipid levels in patients with rheumatoid arthritis.

INTRODUCTION: Rheumatoid arthritis (RA), a systemic inflammatory disease with complex genetic aetiology, associates with excess cardiovascular morbidity and mortality. Dyslipidaemia, a major cardiovascular risk factor has been reported to predate the onset of RA, thus suggesting a potential genetic link between the two conditions. The authors assessed whether RA susceptibility genes associate with the presence of dyslipidaemia in RA patients. METHODS: 400 well-characterised RA patients were included in this cross-sectional study. Fasting lipid profile (total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides, apolipoproteins (ApoA and ApoB) and lipoprotein (a)) and four RA susceptibility genes (PTPN22, TRAF1/C5, STAT4 and human leucocyte antigen shared epitope (HLA-SE)) were assessed and associations were sought in both univariate and multivariate analyses. RESULTS: Following adjustment for age, sex and erythrocyte sedimentation rate, the G allele of TRAF1/C5 associated with lower total cholesterol (p=0.010), LDL (p=0.022) and ApoB (p=0.014); one or more copies of the shared epitope associated with lower ApoA (p=0.035) and higher ApoB:ApoA ratio (p=0.047); while STAT4 TT homozygotes had higher lipoprotein (a) (p=0.004). CONCLUSIONS: RA susceptibility genes (TRAF1/C5, STAT4 and HLA-DRB1-SE) may be involved in the regulation of lipid metabolism in RA patients, thus contributing to cardiovascular disease (CVD) risk and adverse outcome. If these findings are replicated, such genotyping could be used to identify and target for prevention those RA patients most at risk of CVD. It will also be interesting to study the association of these genes with lipid levels in the general population and identify mechanisms to explain the link.