Intravascular Ultrasound during Endovascular Intervention for Peripheral Artery Disease, By Severity, Location, Device, and Procedure.

There is limited evidence for the role of Intravascular Ultrasound (IVUS) in patients undergoing peripheral vascular intervention (PVI). We conducted retrospective cohort study utilizing the HCUP-AHRQ National Readmission database(NRD) to delineate outcomes in IVUS guided PVI versus non-IVUS guided PVI. The current study utilized NRD between January 1, 2016, and December 31, 2019. We identified patients undergoing endovascular intervention for peripheral artery disease using relevant ICD-10-PCS. The cohort was divided based on the use of IVUS during the procedure. The primary outcome was major amputation at 6 months after index hospitalization. Measured confounders were matched using propensity score inverse probability of treatment weighing method. We further performed a subgroup analysis based on disease severity, location of intervention, device, and procedure.A total of 434901 hospitalizations were included in the present analysis. PVI with IVUS compared with no IVUS had similar risk of amputation at 6 months (195 of 8939[2.17%] versus 10404 of 384003 [2.71%]);Hazard Ratio,0.98;CI, 0.77-1.25. Further, there was no difference in the rates of secondary outcomes. On subgroup analysis, amputation rates were significantly lower among patients with rest pain, in iliac intervention, or patients undergoing drug eluting stent implantation with the use of IVUS compared with no IVUS. This nationwide observational study showed that there was no difference in major amputation rates with the use of IVUS in patients undergoing PVI. However, in subgroup of patients with rest pain, iliac intervention or drug-eluting stent implantation IVUS use was associated with significantly lower major amputation rates.

Nationwide Trends and Outcomes for Coronary Artery Bypass Grafting in End-Stage Kidney Disease and Stable Coronary Artery Disease.

Patients with end-stage kidney disease (ESKD) on dialysis have an increased burden of coronary artery disease (CAD). This study assessed the trend and outcomes for coronary artery bypass surgery (CABG) in patients with ESKD and stable CAD. We conducted a longitudinal study using the United States Renal Data System of patients with ESKD and stable CAD who underwent CABG from the years 2009 to 2017. The outcomes included in-hospital, long-term mortality, and repeat revascularization. The follow-up was until death, end of Medicare AB coverage, or December 31, 2018. A total of 11,952 patients were identified. The mean age was 62.8 years, 68% were male, and 67% were white. The common co-morbidities included hypertension (97%), diabetes mellitus (75%), and congestive heart failure (53%). A significant decrease in CABG procedures from 2.9 to 1.3 procedures per 1,000 patients with ESKD (p <0.001) was noted during the years studied. The overall in-hospital mortality rate was 5.9%, and there was a significant decrease over the study period (p = 0.01). Although the 30-day mortality rate was 6.9% and remained steady (p = 0.14), the 1-year mortality rate was 22.8% and decreased significantly (p <0.001). At 5 years, the overall survival rate was 35%, and patients with internal mammary artery grafts showed better survival than those without (36% vs 25%). In conclusion, there has been a decrease in CABG procedures performed in patients with ESKD with stable CAD with decreasing in-hospital and 1-year mortality. Those with an internal mammary artery graft do better, but the overall long-term survival remains dismal in this population. There remains need for caution and individualization of revascularization decisions in this high-risk population.

Aspirin for Primary Prevention in Patients With Elevated Coronary Artery Calcium Score: A Systematic Review of Current Evidences.

The 2019 American College of Cardiology and American Heart Association guidelines regarding low-dose aspirin in the primary prevention of atherosclerotic cardiovascular disease (ASCVD) indicate an increased risk of bleeding without a net benefit. The coronary artery calcium (CAC) score could be used to guide aspirin therapy in high-risk patients without an increased risk of bleeding. With this systematic review, we aimed to analyze studies that have investigated the role of CAC in primary prevention with aspirin. A total of 4 relevant studies were identified and the primary outcomes of interest were bleeding events and major adverse cardiac events. The outcomes of interest were stratified into 3 groups based on CAC scoring: 0, 1 to 99, and ≥100. A study concluded from 2,191 patients that with a low bleeding risk, CAC ≥100, and ASCVD risk ≥5% aspirin confers a net benefit, whereas patients with a high bleeding risk would experience a net harm, irrespective of ASCVD risk or CAC. All other studies demonstrated net benefit in patients with CAC ≥100 with a clear benefit. CAC scores correspond to calcified plaque in coronary vessels and are associated with graded increase in adverse cardiovascular events. Our review has found that in the absence of a significant bleeding risk, increased ASCVD risk and CAC score corelate with increased benefit from aspirin. A study demonstrated a decrease in the odds of myocardial infarction from 3 to 0.56 in patients on aspirin. The major drawback of aspirin for primary prevention is the bleeding complication. At present, there is no widely validated tool to predict the bleeding risk with aspirin, which creates difficulties in accurately delineating risk. Barring some discrepancy between studies, evidence shows a net harm for the use of aspirin in low ASCVD risk (<5%), irrespective of CAC score.

Social associations and cardiovascular mortality in the United States counties, 2016 to 2020.

BACKGROUND: The positive aspects of social interaction on health have been described often, with considerably less attention to their negative aspect. This study aimed to assess the impact of social associations on cardiovascular mortality in the United States. METHODS: The Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) data sets from 2016 to 2020 were used to identify death records due to cardiovascular disease in the United States population aged 15 years and older. The social association rate defined as membership associations per 10,000 population, accessed from the 2020 County Health Rankings data was used as a surrogate for social participation. All United States counties were grouped into quartiles based on their social association rate; Q1 being the lowest quartile of social association, and Q4 the highest quartile. Age-adjusted mortality rate (AAMR) was calculated for each quartile. County health factor rankings for the state of Texas were used to adjust the AAMR for baseline comorbidities of county population, using Gaussian distribution linear regression. RESULTS: Overall, the AAMR was highest in the 4th social association rate quartile (306.73 [95% CI, 305.72-307.74]) and lowest in the 1st social association rate quartile (266.80 [95% CI, 266.41-267.20]). The mortality rates increased in a linear pattern from lowest to highest social association rate quartiles. After adjustment for the county health factor ranks of Texas, higher social association rate remained associated with a significantly higher AAMR (coefficient 15.84 [95% CI, 12.78-18.89]). CONCLUSIONS: Our study reported higher cardiovascular AAMR with higher social associations in the United States, with similar results after adjustment for County Health Rankings in the state of Texas.

Bicuspid Aortic Valve Disease: Classifications, Treatments, and Emerging Transcatheter Paradigms.

Bicuspid aortic valve (BAV) is a common congenital valvular malformation, which may lead to early aortic valve disease and bicuspid-associated aortopathy. A novel BAV classification system was recently proposed to coincide with transcatheter aortic valve replacement being increasingly considered in younger patients with symptomatic BAV, with good clinical results, yet without randomized trial evidence. Procedural technique, along with clinical outcomes, have considerably improved in BAV patients compared with tricuspid aortic stenosis patients undergoing transcatheter aortic valve replacement. The present review summarizes the novel BAV classification systems and examines contemporary surgical and transcatheter approaches.

Trends in cardiac implantable electronic device utilization in adults with congenital heart disease: a US nationwide analysis.

BACKGROUND: Adults with congenital heart disease (ACHD) have increased risk of arrhythmias warranting implantation of cardiac implantable electronic devices (CIEDs), which may parallel the observed increase in survival of ACHD patients over the past few decades. We sought to characterize the trends and outcomes of CIED implantation in the inpatient ACHD population across US from 2005 to 2019. METHODS: A retrospective analysis of the Nationwide Inpatient Sample (NIS) identified 1,599,519 unique inpatient ACHD admissions (stratified as simple (85.1%), moderate (11.5%), and complex (3.4%)) using the International Classification of Diseases 9/10-CM codes. Hospitalizations for CIED implantation (pacemaker, ICD, CRT-p/CRT-d) were identified and the trends analyzed using regression analysis (2-tailed p < 0.05 was considered significant). RESULTS: A significant decrease in the hospitalizations for CIED implantation across the study period [3.3 (2.9-3.8)% in 2005 vs 2.4 (2.1-2.6)% in 2019, p < 0.001] was observed across all types of devices and CHD severities. Pacemaker implantation increased with each age decade, whereas ICD implantation rates decreased over 70 years of age. Complex ACHD patients receiving CIED were younger with a lower prevalence of age-related comorbidities, however, had a greater prevalence of atrial/ventricular tachyarrhythmias and complete heart block. The observed inpatient mortality rate was 1.2%. CONCLUSIONS: In a nationwide analysis, we report a significant decline in CIED implantation between 2005 and 2019 in ACHD patients. This may either be due to a greater proportion of hospitalizations resulting from other complications of ACHD or reflect a declining need for CIED due to advances in medical/surgical therapies. Future prospective studies are needed to elucidate this trend further.

Impact of preexisting coronary artery and peripheral artery disease on outcomes in diabetic patients after kidney transplant.

BACKGROUND: Atherosclerotic cardiovascular disease is highly prevalent in patients with end-stage kidney disease (ESKD). Kidney transplant (KT) improves patient survival and cardiovascular outcomes. The impact of preexisting coronary artery disease (CAD) and peripheral artery disease (PAD) on posttransplant outcomes remains unclear. METHODS: This is a retrospective study utilizing the United States Renal Data System. Adult diabetic dialysis patients who underwent first KT between 2006 and 2017 were included. The study population was divided into four cohorts based on presence of CAD/PAD: (1) polyvascular disease (CAD + PAD); (2) CAD without PAD; (3) PAD without CAD; (4) no CAD or PAD (reference cohort). The primary outcome was 3-year all-cause mortality. Secondary outcomes were incidence of posttransplant myocardial infarction (MI), cerebrovascular accidents (CVA), and graft failure. RESULTS: The study population included 19,329 patients with 64.4% men, mean age 55.4 years, and median dialysis duration of 2.8 years. Atherosclerotic cardiovascular disease was present in 28% of patients. The median follow up was 3 years. All-cause mortality and incidence of posttransplant MI were higher with CAD and highest in patients with polyvascular disease. The cohort with polyvascular disease had twofold higher all-cause mortality (16.7%, adjusted hazard ratio (aHR) 1.5, p < 0.0001) and a fourfold higher incidence of MI (12.7%, aHR 3.3, p < 0.0001) compared to the reference cohort (8.0% and 3.1%, respectively). There was a higher incidence of posttransplant CVA in the cohort with PAD (3.4%, aHR 1.5, p = 0.01) compared to the reference cohort (2.0%). The cohorts had no difference in graft failure rates. CONCLUSIONS: Preexisting CAD and/or PAD result in worse posttransplant survival and cardiovascular outcomes in patients with diabetes mellitus and ESKD without a reduction in graft survival.

Transcatheter versus surgical mitral valve repair in patients with mitral regurgitation.

OBJECTIVES: The aim of this study was to compare clinical outcomes of transcatheter and surgical mitral valve repair (SMVr) in primary mitral regurgitation (MR) and MR with heart failure with reduced ejection fraction (HFrEF). METHODS: In this retrospective cohort study, we used the Nationwide Readmission Database to identify primary MR and MR with HFrEF patients who underwent transcatheter or SMVr from 2016 to 2019. A propensity score with 1:1 matching was applied. The primary outcome was a cumulative event rate of major adverse cardiovascular events (MACE), which was a composite of all-cause mortality, myocardial infarction, stroke, heart failure, cardiac arrest and mitral valve replacement. Other important secondary outcome was in-hospital mortality. RESULTS: After propensity score matching, 2187 matched pairs were found in the primary MR cohort and 2178 matched pairs were found in the MR-HFrEF cohort. Transcatheter mitral valve repair (TMVr) had significantly higher medium-term MACE compared with SMVr in both cohorts (primary MR: hazard ratio: 1.73, 95% confidence interval: 1.33-2.26, P ≤ 0.001; MR-HFrEF: hazard ratio: 2.00, 95% confidence interval: 1.58-2.54, P ≤ 0.001). TMVr showed similar in-hospital mortality in both cohorts. CONCLUSIONS: Although TMVr showed better short-term outcomes, it had significantly higher medium-term MACE than SMVr in both cohorts. Thus, shared decision-making should be performed for TMVr after discussing the benefits and risks in patients who can undergo SMVr.

Corrigendum: The safety and efficacy of balloon-expandable versus self-expanding trans-catheter aortic valve replacement in high-risk patients.

[This corrects the article DOI: 10.3389/fcvm.2023.1130354.].

Prognostic Value of Hospital Frailty Risk Score and Clinical Outcomes in Patients Undergoing Revascularization for Critical Limb-Threatening Ischemia.

Background The impact of medical record-based frailty assessment on clinical outcomes in patients undergoing revascularization for critical limb-threatening ischemia (CLTI) is unknown. Methods and Results This study included patients with CLTI aged ≥18 years from the nationwide readmissions database 2016 to 2018 who underwent endovascular revascularization (ER) or surgical revascularization (SR). The hospital frailty risk score, a previously validated International Classification of Diseases, Tenth Edition, Clinical Modification (ICD-10-CM) claims-based score, was used to categorize patients into low- (<5), intermediate- (5-15), and high-risk (>15) frailty categories. Primary outcomes were in-hospital mortality and major amputation at 6 months. A total of 64 338 patients were identified who underwent ER (82.3%) or SR (17.7%) for CLTI. The mean (SD) age of the cohort was 69.3 (11.8) years, and 63% of patients were male. This study found a nonlinear association between hospital frailty risk score and in-hospital mortality and 6-month major amputation. In both ER and SR cohorts, the intermediate- and high-risk groups were associated with a significantly higher risk of in-hospital mortality (high-risk group: ER: odds ratio [OR], 7.2 [95% CI, 4.4-11.6], P<0.001; SR: OR, 28.6 [95% CI, 3.4-237.6], P=0.002) and major amputation at 6 months (high-risk group: ER: hazard ratio [HR], 1.6 [95% CI, 1.5-1.7], P<0.001; SR: HR, 1.7 [95% CI, 1.4-2.2], P<0.001) compared with the low-risk group. Conclusions The hospital frailty risk score, generated from the medical record, can identify frailty and predict in-hospital mortality and 6-month major amputation in patients undergoing ER or SR for CLTI. Further studies are needed to assess if this score can be incorporated into clinical decision-making in patients undergoing revascularization for CLTI.

Causes and Predictors of 30-Day Readmission in Patients With COVID-19 and ST-Segment-Elevation Myocardial Infarction in the United States: A Nationwide Readmission Database Analysis.

Background Rates, causes, and predictors of readmission in patients with ST-segment-elevation myocardial infarction (STEMI) during COVID-19 pandemic are unknown. Methods and Results All hospitalizations for STEMI were selected from the US Nationwide Readmissions Database 2020 and were stratified by the presence of COVID-19. Primary outcome was 30-day readmission. Multivariable hierarchical generalized logistic regression analysis was performed to compare 30-day readmission between patients with STEMI with and without COVID-19 and to identify the predictors of 30-day readmissions in patients with STEMI and COVID-19. The rate of 30-day all-cause readmission was 11.4% in patients with STEMI who had COVID-19 and 10.6% in those without COVID-19, with the adjusted odds ratio (OR) not being significantly different between the two groups (OR, 0.88 [95% CI, 0.73-1.07], P=0.200). Of all 30-day readmissions in patients with STEMI and COVID-19, 41% were for cardiac causes. Among the cardiac causes, 56% were secondary to acute coronary syndrome, while among the noncardiac causes, infections were the most prevalent. Among the causes of 30-day readmissions, infectious causes were significantly higher for patients with STEMI who had COVID-19 compared with those without COVID-19 (29.9% versus 11.3%, P=0.001). In a multivariable model, congestive heart failure, chronic kidney disease, low median household income, and length of stay ≥5 days were found to be associated with an increased risk of 30-day readmission. Conclusions Post-STEMI, 30-day readmission rates were similar between patients with and without COVID-19. Cardiac causes were the most common causes for 30-day readmissions, and infections were the most prevalent noncardiac causes.

Similar Events but Contrasting Impact: Appraising the Global Digital Reach of World Heart Day and Atrial Fibrillation Awareness Month.

Background: With over 18.6 million deaths annually, cardiovascular diseases (CVDs) are the leading cause of mortality worldwide. One such complication of CVDs that can result in stroke is atrial fibrillation (Afib). As part of global outreach and awareness, World Heart Day and Atrial Fibrillation Awareness Month are celebrated annually on 29 September and the month of September, respectively. Both of these events are important cardiovascular awareness initiatives to assist public education and develop awareness strategies, and they have received considerable support from leading international organizations. Objective: We studied the global digital impact of these campaigns via Google Trends and Twitter. Methods: We evaluated the overall number of tweets, impressions, popularity and top keywords/hashtags, and interest by region to determine the digital impact using various analytical tools. Hashtag network analysis was done using ForceAtlas2 model. Beyond social media, Google Trends web search analysis was carried out for both awareness campaigns to examine 'interest by region' over the past five years by analyzing relative search volume. Results: #WorldHeartDay and #UseHeart (dedicated social media hashtags for World Heart Day by the World Heart Federation) alone amassed over 1.005 billion and 41.89 million impressions as compared with the 1.62 million and 4.42 million impressions of #AfibMonth and #AfibAwarenessMonth, respectively. On Google Trends web search analysis, the impact of Afib awareness month was limited to the USA, but World Heart Day had a comparatively global reach with limited digital involvement in the African continent. Conclusions: World Heart Day and Afib awareness month present a compelling case study of vast digital impact and the effectiveness of targeted campaigning using specific themes and keywords. Though the efforts of the backing organizations are commended, planning and collaboration are needed to further widen the reach of Afib awareness month.

The safety and efficacy of balloon-expandable versus self-expanding trans-catheter aortic valve replacement in high-risk patients with severe symptomatic aortic stenosis.

Aim: Transfemoral Trans-catheter Aortic Valve Replacement (TF-TAVR) is a safe and effective therapy compared with surgical aortic valve replacement (SAVR) in patients across all risk profiles using balloon-expandable valves (BEV) and self-expanding valves (SEV). Our aim was to compare safety and efficacy of BEV vs. SEV in high-risk patients undergoing TF-TAVR. Methods and results: We searched PubMed, EMBASE, Clinicaltrials.gov, Scopus, and Web of sciences for studies on patients with severe aortic stenosis undergoing TAVR. Primary outcome was 30-day all-cause mortality. Secondary outcomes defined by Valve Academic Research Consortium 2 (VARC-2) criteria were also examined. Six studies with 2,935 patients (1,439 to BEV and 1,496 to SEV) were included. BEV was associated with lower risk of all-cause mortality (2.2% vs. 4.5%; RR: 0.51; 95% CI: 0.31-0.82; p < 0.006) and cardiovascular mortality [(2.5% vs. 4.3%; RR: 0.54; 95% CI: 0.32-0.90; p = 0.01) at 30 days compared with SEV. Implantation of more than one valve per procedure (0.78% vs. 5.11%; RR: 0.15; 95% CI: 0.07-0.31; p < 0.00001), and moderate/severe AR/PVL (2.5% vs. 9.01%; RR: 0.3; 95% CI: 0.17-0.48); p < 0.00001) were also lower in the BEV arm. Conclusion: BEV TAVR is associated with reduced all-cause mortality (High level of GRADE evidence), cardiovascular mortality (very low level) at 30 days compared with SEV TAVR in high surgical risk patients. Data are necessary to determine if the difference in outcomes persists in longer-term and if the same effects are seen in lower-risk patients. Systematic Review Registration: identifier, CRD42020181190.

Predictors of Major Adverse Cardiovascular Events in Patients With Moderate Aortic Stenosis: Implications for Aortic Valve Replacement.

BACKGROUND: Although the prognosis and management of severe aortic stenosis has been extensively studied, the risk stratification and outcomes of patients with moderate aortic stenosis remain elusive. METHODS: This study included 674 patients from the Cleveland Clinic Health System with moderate aortic stenosis (aortic valve area, 1-1.5 cm2; mean gradient, 20-40 mm Hg; and peak velocity <4 m/s) and an NT-proBNP (N-terminal pro-B-type natriuretic peptide) level within 3 months of index diagnosis. The primary outcome of major adverse cardiovascular events (defined as the composite outcome of progression to severe aortic stenosis requiring aortic valve replacement, heart failure hospitalization, or death) was extracted from the electronic medical record. RESULTS: The mean age was 75.3±12 years, and 57% were men. During a median follow-up of 316 days, the composite end point occurred in 305 patients. There were 132 (19.6%) deaths, 144 (21.4%) heart failure hospitalizations, and 114 (16.9%) patients underwent aortic valve replacement. Elevated NT-proBNP (1.41 [95% CI, 1.01-1.95]; P=0.048), diabetes (1.46 [95% CI, 1.08-1.96]; P=0.01), elevated averaged mitral valve E/e' ratio (hazard ratio, 1.57 [95% CI, 1.18-2.10]; P<0.01), and presence atrial fibrillation at the time of index echocardiogram (hazard ratio, 1.83 [95% CI, 1.15-2.91]; P=0.01) were each independently associated with an increased hazard for the composite outcome and when taken collectively, each of these factors incrementally increased risk. CONCLUSIONS: These results further elucidate the relatively poor short-medium term outcomes and risk stratification of patients with moderate aortic stenosis, supporting randomized trials assessing the efficacy of transcatheter aortic valve replacement in this population.

Impact of Gender, Race, and Insurance Status on Inhospital Management and Outcomes in Patients With COVID-19 and ST-Elevation Myocardial Infarction (a Nationwide Analysis).

There is a paucity of data exploring the impact of gender, race, and insurance status on invasive management and inhospital mortality in patients with COVID-19 with ST-elevation myocardial infarction (STEMI) in the United States. The National Inpatient Sample database for the year 2020 was queried to identify all adult hospitalizations with STEMI and concurrent COVID-19. A total of 5,990 patients with COVID-19 with STEMI were identified. Women had 31% lower odds of invasive management and 32% lower odds of coronary revascularization than men. Black patients had lower odds of invasive management (odds ratio [OR] 0.61, 95% confidence interval [CI] 0.43 to 0.85, p = 0.004) than White patients. Black and Asian patients had lower odds of percutaneous coronary intervention (Black: OR 0.55, 95% CI 0.38 to 0.80, p = 0.002; Asian: OR 0.39, 95% CI 0.18 to 0.85, p = 0.018) than White patients. Uninsured patients had higher odds of getting percutaneous coronary intervention (OR 1.78, 95% CI 1.05 to 2.98, p = 0.031) and lower odds of inhospital mortality (OR 0.41, 95% CI 0.19 to 0.89, p = 0.023) than privately insured patients. Patients with out-of-hospital STEMI had 19 times higher odds of invasive management and 80% lower odds of inhospital mortality than inhospital STEMI. In conclusion, we note important gender and racial disparities in invasive management of patients with COVID-19 with STEMI. Surprisingly, uninsured patients had higher revascularization rates and lower mortality than privately insured patients.

Surgical and transcatheter left atrial appendage closure in patients with atrial fibrillation and hypertrophic cardiomyopathy.

BACKGROUND: Patients with hypertrophic cardiomyopathy (HCM) and atrial fibrillation (AF) are at increased stroke risk in comparison to those with non-valvular AF not affected by HCM. OBJECTIVES: To investigate the role of left atrial appendage closure (LAAC) in patients with HCM and AF. METHODS AND RESULTS: We identified patients with HCM and AF using the National Readmission Dataset. Patients were stratified based on LAAC status. The primary efficacy outcome was a composite of ischaemic and haemorrhagic stroke, TIA, and all-cause mortality. The primary safety outcome was a composite of major bleeding and pericardial complications. Patients were matched using inverse probability of treatment weighting. Cox-proportional hazard regression was applied to calculate the hazard ratio (HR) with a 95% confidence interval (CI) on matched cohorts. We identified 71 980 patients with HCM and AF. 1351 (1.9%) patients underwent LAAC. Two hundred and eighty-seven (21.2%) underwent transcatheter LAAC. LAAC was associated with a lower risk of the primary efficacy outcome (2.5% vs. 5.4%, HR: 0.38; 95% CI: 0.17-0.88; P = 0.024), the primary safety outcome (2.9% vs. 6.8%, HR: 0.39; 95% CI: 0.23-0.66, P = 0.001), and reduced major bleeding. The LAAC group trended towards a lower risk of ischaemic stroke and all-cause mortality. CONCLUSION: Surgical and transcatheter LAAC was associated with a lower risk of haemorrhagic stroke and major bleeding.

Impact of Biopsy Proven Liver Fibrosis on Patients Undergoing Evaluation and Treatment for Advanced Heart Failure Surgical Therapies.

There is a paucity of data regarding the impact of liver fibrosis on patients with stage D heart failure (HF). We conducted a retrospective study (January 1, 2017 to December 12, 2020) in patients with stage D HF who underwent liver biopsy as part of their advanced HF therapy evaluation. Baseline characteristics and 1-year outcomes were compared between no- or mild-to-moderate-fibrosis (grade 0 to 2) and advanced-fibrosis (grade 3 to 4) groups. Of 519 patients with stage D HF, 136 who underwent liver biopsy (113 [83%] no or mild-to-moderate fibrosis and 23 [17%] advanced fibrosis) were included. A total of 71 patients (52%) received advanced HF therapies (23 heart transplantation, 48 left ventricular assist devices). One-year mortality was higher among patients with advanced fibrosis (52% vs 18%, p <0.001). Further subgroup analysis suggested a trend toward increased 1-year mortality among patients with advanced fibrosis who underwent advanced therapies (37% vs 13%, p = 0.09). There was a trend of lower likelihood of receiving advanced HF therapies in the advanced-fibrosis group, only 1 heart transplantation and 7 left ventricular assist devices, but it did not reach statistical significance (35% vs 56%, p = 0.06). After adjustment for confounders, degree of liver fibrosis was an independent predictor of mortality (odds ratio 6.2; 95% 1.27 to 30.29, p = 0.02). We conclude that advanced liver fibrosis is common among patients with stage D HF who undergo evaluation for advanced HF surgical therapies and significantly increases 1-year mortality. Further larger studies are needed to support our findings.

Clinical outcomes of MANTA vs suture-based vascular closure devices after transcatheter aortic valve replacement: An updated meta-analysis.

OBJECTIVE: A recently published randomized control trial showed different results with suture-based vascular closure device (VCD) than plug-based VCD in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The learning curve for MANTA device is steep, while the learning curve for suture based VCD is shallow as the devices are quite different. In this meta-analysis, we have compared suture-based (ProGlide and Prostar XL) vs plug-based VCDs (MANTA). METHODS: We performed a meta-analysis of all published studies (using PubMed/Medline and Cochrane databases) reporting the clinical outcome of plug-based vs suture-based VCDs in transfemoral TAVR patients. RESULTS: We included nine studies with a total of 2865 patients (plug-based n = 1631, suture-based n = 1234). There was no significant difference in primary outcome of all bleeding when using plug-based as opposed to suture-based VCDs (RR 1.14 [0.62-2.06] I2 = 72%). There was no significant difference in the incidence of secondary outcomes between two groups including major life threatening bleeding (RR 1.16 [0.38-3.58] I2 = 65%), major vascular complications (RR 0.84 [0.35-2.00] I2 = 55%), minor vascular complications (RR 1.05 [0.56-1.95] I2 = 42%), pseudo aneurysm (RR 1.84 [0.11-29.98] I2 = 44%), stenosis-dissection (RR 0.98 [0.66-1.47] I2 = 0%), VCD failure (RR 1.71 [0.96-3.04] I2 = 0%), and blood transfusion (RR 1.01 [0.38-2.71], I2 = 61%). CONCLUSION: Large bore arteriotomy closure with plug-based VCD was not superior to suture-based VCDs in this transfemoral TAVR population. There was very frequent use of secondary VCDs in suture-based VCD group which is not practical when using MANTA. Additional high-powered studies are required to determine the safety and efficacy of MANTA device.