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Aim: To evaluate outcomes after percutaneous coronary intervention (PCI) in patients with cancer and atrial fibrillation (AF)., Methods: Data of all adult discharges undergoing PCI between October 2015 and December 2018 were obtained from the National Inpatient Sample (NIS) database. Adjusted odds ratios (aOR) of adverse complications were calculated using binominal logistic regression., Results: 1387320 patients were detected, out of which 15.4% had AF but no cancer, 1.9% had cancer but no AF, and 0.6% had both cancer and AF. Compared with cancer patients without AF, those with AF had a greater aOR of mortality (aOR 1.20, 95%CI 1.08-1.33), major adverse cardiac and cerebrovascular events (MACCE) (aOR 1.18, 95%CI 1.07-1.29), and bleeding (aOR 1.23, 95%CI 1.08-1.39). However, the risk of ischemic stroke was similar between the two groups. Patients with solid cancer and AF had a higher aOR for all outcomes, including mortality (aOR 1.28, 95%CI 1.09-1.50), MACCE (aOR 1.37, 95%CI 1.19-1.57), ischemic stroke (aOR 1.48, 95%CI 1.10-1.99), and bleeding (aOR 1.66, 95%CI 1.39-1.98) compared with the solid cancer group without AF. In patients with hematological cancer, AF was associated only with significantly increased risk of mortality (aOR 1.40, 95%CI 1.16-1.70) and MACCE (aOR 1.26, 95%CI 1.06-1.49)., Conclusions: The presence of AF in solid cancer patients increases the risk of mortality, MACCE, stroke, and major bleeding, while in the setting of hematological cancer it is only associated with a higher risk of mortality and MACCE.

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment option for patients with severe aortic stenosis regardless of surgical risk, particularly in those with a high and prohibitive risk. Since the advent of TAVR, transfemoral access has been the standard of care. However, given comorbidities and anatomical limitations, a proportion of patients are not good candidates for a transfemoral approach. Alternative access, including transapical, transaortic, transaxillary, transsubclavian, transcarotid, and transcaval, can be considered. Each alternative access has advantages and disadvantages, so the vascular route should be tailored to the patient's characteristics. However, there is no standardized algorithm when choosing the optimal alternative vascular access. In this review, we analyzed the evolution and current evidence for the most common alternative access for TAVR and proposed an algorithm for choosing the optimal vascular access in this patient population.

Background: Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve., Methods: The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT04415047, and is ongoing., Findings: Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2-34·0]) patients (p non-inferiority <0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3-12·3]) patients at 1 year (p non-inferiority <0·0001)., Interpretation: This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary., Funding: JenaValve Technology., Competing Interests: Declaration of interests TPV reports institutional funding to Columbia University Irving Medical Center from JenaValve Technology, Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and he personally received consulting fees from 4C Medical and Philips. OKK reports that he is part of a core laboratory contracting with JenaValve Technology but he has not received any direct compensation; he further reports consulting fees from Edwards Lifesciences, VDyne, Siemens, Philips, Laralab, and Restore Medical. NH reports that she is part of a core laboratory contracting with JenaValve Technology but she has not received any direct compensation. JMM reports consulting fees and honoraria from Edwards Lifesciences, Medtronic, Abbott, Shockwave, and Equity in Excision Medical, and Conkay Medical. IG reports consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott SJM, and Atricure. SKK reports consultant fees (honoraria) from Admedus, Meril Lifesciences, JenaValve Technology, and Abbott Vascular; scientific advisory board participation (equity) with Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus; and institutional funding to Columbia University and the Cardiovascular Research Foundation from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve Technology. NA reports medical advisory board fees and consultant and proctor fees from Nininger Medical, Edwards Lifesciences, V-wave, JenaValve Technology, Abbott, Vdyne, and Boston Scientific, and participation in industry-sponsored trials and research funding from Edwards Lifesciences, JenaValve Technology, Boston Scientific, V-wave, AccuCinch, Highlife, Tendyne, and preCardia. DSP is the Chief Medical officer of JenaValve Technology and a consultant for Abiomed, Abbott Vascular, Magenta, NuPulseCV, and Terumo. MBL reports institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and JenaValve Technology. HG reports consulting fees from Medtronic and Boston Scientific. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Functional mitral regurgitation appears commonly among all heart failure phenotypes and can affect symptom burden and degree of maladaptive remodeling. Transcatheter mitral valve edge-to-edge repair therapies recently became an important part of the routine heart failure armamentarium for carefully selected and medically optimized candidates. Patient selection is considering heart failure staging, relevant comorbidities, as well as anatomic criteria. Indications and device platforms are currently expanding., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Degenerative mitral regurgitation (DMR) has earned great interest because of modern and innovative technologies emerging in its treatment. MR affects roughly one-tenth of those older adults over the age of 75. MR if untreated leads to adverse heart remodeling, resulting in left ventricular dysfunction, pulmonary hypertension, and heart failure syndrome. Despite surgical valve repair/replacement treatment being the standard of care, a significant proportion of severe MR patients face unmet clinical needs because of high or prohibitive surgical risks. This has led to the emergence of transcatheter therapies for high- and prohibitive-risk surgical patients, most notably mitral transcatheter edge-to-edge repair devices., Competing Interests: Disclosures None. H. Golwala serves as an advisory consultant for Medtronic and Boston Scientific., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Despite an association between operator volumes and procedural success, there remains an incomplete understanding of the contemporary utilization and procedural volumes for mitral valve transcatheter edge-to-edge repair (MTEER). We aimed to identify annual operator procedural volumes, temporal trends, and geographic variability for MTEER among Medicare patients in the United States (US)., Methods: We queried the National Medicare Provider Utilization and Payment Database for a CPT code (33418) specific for MitraClip device from 2015 through 2019. We analyzed annual operator procedural volumes and incidence and identified longitudinal and geographic trends in MTEER utilization., Results: From 2015 through 2019, a total of 27,034 MTEER procedures were performed among Medicare patients in the US. The nationwide incidence increased from 6.2 per 100,000 patients in 2015 to 23.8 per 100,000 patients in 2019, a 283% increase over the study period ( P trend  < 0.001). The incidence of MTEER by state varied by nearly 900% (range 5.5 to 54.9 per 100,000 person-years). In 2019, the mean annual MTEER operator annual volume was 9.1 MTEER procedures and had grown from 6.2 per year in 2015., Conclusions: In this nationwide study of Medicare beneficiaries in the United States, we identified a significant and sustained increase in the utilization of MTEER devices and operators and growth in annual procedural volumes from 2015 through 2019 with considerable variability in utilization by state. Further studies are needed to understand the clinical impact of variability in utilization and the optimal procedural volumes to ensure high efficacy outcomes and maintain critical access to MTEER therapies., Competing Interests: Zahr reports research grants from Edwards Lifesciences, Medtronic, and Siemens. Sorajja reports service as a consultant for Abbot Vascular, Edwards Lifesciences, Medtronic, Boston Scientific, TriFlo, and VDyne. Reeves reports service as consultant for Edwards Lifesciences and research grants from Edwards Lifesciences, Avicenna, and Ventrix. Song reports service as a consultant for Medtronic and Edwards Lifesciences. Smith reports service as a consultant for Edwards Lifesciences and CryoLife and research grant from Abbott Vascular and Edwards Lifesciences. Chadderdon reports service as an educational consultant for Medtronic and Edwards Lifesciences. Chhatriwalla reports service as a consultant for Abbott Vascular, Edwards Lifesciences, and Medtronic and research grant from Boston Scientific. Golwala reports service as an advisory consultant for Medtronic and Boston Scientific. All other authors declare that they have no conflicts of interest., (Copyright © 2023 Kris Kumar et al.)

Chest radiation therapy (XRT) has been associated with a higher rate of mortality following surgical aortic valve replacement. We performed a single-center retrospective analysis of patients with severe AS who underwent TAVI from January 1 2012 to July 31 2020 comparing patients with and without XRT. A total of 915 patients met inclusion criteria, with a total of 50 patients found to have a history of XRT. At a mean follow-up of 2.4 years, unadjusted and propensity score matching analysis demonstrated no differences in mortality, heart failure or bleeding-related hospitalization, overall stroke, and 30-day pacemaker implantation in patients with and without XRT.

Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Background: There is an incomplete understanding of the predictors of morbidity and mortality in patients with severe tricuspid regurgitation (TR). This study sought to identify key risk factors for all-cause mortality and heart failure (HF) hospitalization among patients with severe TR., Methods: Patients with severe TR were identified from 2 centers, Oregon Health & Science University and Abrazo Health, from January 01, 2016 to December 31, 2018. Patients with any concomitant severe valvular diseases or prior valvular intervention were excluded. Multivariable regression was utilized to identify demographic, clinical, and echocardiographic variables independently associated with all-cause mortality or HF hospitalization., Results: 435 patients with severe TR were followed for a median of 2.8 years. The mean age of the population was 66.9 ± 18.5 years and 58% were female. All-cause mortality was identified in 20.5% of the population. Of the cohort, 35.4% of patients were hospitalized for HF. Isolated tricuspid valve intervention was performed in 2.5% of patients. Independent predictors of all-cause mortality included history of solid tumor (odds ratio [OR] 6.6, 95% confidence interval [CI] 2.1-19.1, p = 0.001), history of peripheral artery disease (OR 3.5, 95% CI 1.2-9.4, p = 0.013), and elevated international normalized ratio in the absence of anticoagulation (OR 1.9, 95% CI 1.2-3.2, p = 0.008). Predictors of HF hospitalization included history of diabetes mellitus (OR 2.2, 95% CI 1.1-4.0, p = 0.014) and history of reduced left ventricular ejection fraction (OR 5.7, 95% CI 2.9-11.7, p < 0.0001)., Conclusions: Severe untreated TR is associated with high mortality and frequent HF hospitalizations. Understanding predictors of these outcomes is important to identify patients who may benefit from early tricuspid valve intervention to help improve outcomes in this patient population., Competing Interests: Dr. Zahr reports research grants from Edwards Lifesciences, Medtronic and Siemens. Dr. Zahr is also an Associate Editor of Structural Heart Journal. Dr. Golwala reports serves as an advisory consultant for Medtronic. Dr. Song reports serves as a consultant for Medtronic and Edwards Lifesciences. Dr. Chadderdon reports is an educational consultant for Medtronic and Edwards Lifesciences. Dr. Byrne reports is an educational consultant and proctor for Medtronic and is a proctor for Abbott Vascular. The other authors had no conflicts to declare., (© 2022 The Authors.)

Background: Prior studies on revascularization prior to transcatheter aortic valve replacement (TAVR), in patients with significant coronary artery disease (CAD), have reported mixed results., Aim: We sought to perform a meta-analysis combining current evidence by investigating outcomes of revascularization in patients who undergo TAVR with coexisting CAD., Methods: We searched literature for studies reporting on outcomes following TAVR performed with versus without pre-TAVR PCI, for coexisting CAD. Random-effect model was used to pool estimates of odds ratios (ORs)., Results: Twenty-four reports with 12,182 TAVR patients were included: 22 observational and 2 clinical trials. 4,110 (33.7%) were in the pre-TAVR PCI group, 51.4% were females, and mean age was 81.9 years. The 30-day mortality was 5.2% versus 5.0% in patients with versus without pre-TAVR PCI, respectively [OR= 1.19 (95% CI: 0.91-1.55, P= 0.20)]. Pooled 1-year mortality was 18.1% versus 19.1% in patients with versus without pre-TAVR PCI (OR= 1.12, 95% CI: 0.95-1.31, P= 0.61). There was no significant difference between the groups for myocardial infarction, stroke, acute kidney injury, pacemaker implantation, or re-hospitalization. Pre-TAVR PCI was associated with an increased risk of life-threatening bleeding at 30 days., Conclusion: Pre-TAVR revascularization with PCI was not associated with improved 30-day or 1-year mortality; however, it was associated with an increased risk of life-threatening bleeding at 30-day post-TAVR. Our results do not support routine revascularization with PCI prior to TAVR with coexisting CAD. Future trials addressing anatomical complexity and symptom burden may help better risk stratify patients who may benefit from pre-TAVR revascularization., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: There is a paucity of data on cardiogenic shock (CS) incidence and outcomes among patients with spontaneous coronary artery dissection (SCAD)., Methods: Women admitted to the hospital for acute myocardial infarction (AMI) with and without SCAD were identified from the United States National Readmission Database from October 1, 2015 to December 31, 2018. We calculated the incidence of CS among women with AMI with and without SCAD and odds for developing CS after adjusting for baseline characteristics. In addition, we report the utilization of percutaneous coronary intervention, mechanical circulatory support, severe disability surrogates, and 30-day readmission rates., Results: A total of 664,292 patients admitted for AMI were eligible for analysis, including 6643 patients with SCAD and 657,649 without SCAD. Patients with SCAD were younger (57 years [interquartile range, IQR 48-68] vs. 71 years [IQR 60-81], p < 0.01) and had fewer comorbidities yet had a higher incidence of CS as compared to patients without SCAD (9% vs. 5%, p < 0.01) and remained at elevated risk after adjusting for baseline comorbidities (adjusted odds ratio 1.5 [95% confidence interval, CI 1.2-1.7]). Among patients who developed CS, those with SCAD had lower in-hospital mortality than non-SCAD (31% vs. 39%, p < 0.01), and were more likely to receive mechanical circulatory support., Conclusions: In a nationally representative sample of women admitted for AMI, we found that patients with SCAD had a higher risk of developing CS and required more frequent use of mechanical circulatory support but were more likely to survive to discharge than women suffering AMI from causes other than SCAD., (© 2022 Wiley Periodicals LLC.)

Background: Small reference vessel diameters (RVDs) are a predictor of ischemic events after coronary stenting. Among patients at high bleeding risk (HBR) precluding long-term dual antiplatelet therapy (DAPT), those with small vessel disease (SVD) constitute an especially high-risk subgroup. Here, we evaluated the results of a durable-polymer, coronary zotarolimus-eluting stent (ZES) for the treatment of patients with SVD at HBR with 1-month DAPT., Methods: In the prospective, multicenter Onyx ONE (One-Month DAPT) Clear study, 1506 patients at HBR treated with a ZES that discontinued DAPT at 30 days were included. The clinical outcomes of patients undergoing treatment of lesions with an RVD of ≤2.5 mm (SVD group, as determined by the angiographic core laboratory) were compared with patients without SVD. The primary end point was the composite of cardiac death or myocardial infarction between 1 and 12 months., Results: Small vessel diameter treatment was performed in 489 (32.5%) patients. Patients with SVD were more likely to be women, have undergone a previous percutaneous intervention, and have multivessel coronary artery disease than patients without SVD. There were no significant differences in lesion, device, or procedural success between the groups. The Kaplan-Meier rate estimate of the primary end point was 8.5% and 6.8% in patients with SVD and those without SVD, respectively ( P = .425). No significant differences were found in any secondary end point. The Kaplan-Meier rate of stent thrombosis was 0.6% and 0.8% in patients with SVD and those without SVD, respectively ( P = .50)., Conclusions: Among patients at HBR treated with a ZES and 1-month DAPT, those with SVD had favorable 12-month ischemic and bleeding outcomes, which were comparable with those of patients with larger caliber vessels., (© 2022 Medtronic.)

Competing Interests: The authors report no conflict of interest.

Platelet aggregation and thrombus formation represent the basic mechanism for clinical, electrocardiographic, and biomarker changes consistent with acute coronary syndrome. Various oral and intravenous formulations of platelet function inhibitors have been developed to help decrease platelet aggregation due to acute atherosclerotic plaque rupture. In this article, we review the various mechanisms, pharmacokinetics/pharmacodynamics, and the key clinical trials related to the platelet inhibitors that form the basis for current recommendations of their use in the ST elevation myocardial infarction guidelines by the American College of Cardiology/American Heart Association., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Mitral regurgitation is the most common form of valvular heart disease worldwide, however, there is an incomplete understanding of predictors of mortality in this population. This study sought to identify risk factors of mortality in a real-world population with mitral regurgitation., Methods: All patients with moderate or severe mitral regurgitation were identified at a single center from January 1, 2016 to August 31, 2017. Multivariate regression was performed to evaluate variables independently associated with all-cause mortality., Results: A total of 490 patients with moderate (76.3%) or severe (23.7%) mitral regurgitation due to primary (20.8%) or secondary (79.2%) etiology were identified. The mean age was 66.7 years; 50% were male. At a median follow-up of 3.1 years, the incidence of all-cause mortality was 30.1%, heart failure hospitalization 23.1%, and mitral valve intervention 11.6%. Of 117 variables, multivariate analysis demonstrated 5 that were independently predictive of mortality: baseline creatinine (hazard ratio [HR] 1.2; 95% CI, 1.0-1.3; P = .02), right atrial pressure by echocardiogram (HR 1.3; 95% CI, 1.07-1.55; P = .008), hemoglobin (HR 0.65; 95% CI, 0.52-0.83; P = .001), hospitalization for heart failure (HR 1.6; 95% CI, 1.1-2.4; P = .015), and mitral valve intervention (HR 0.40; 95% CI, 0.16-0.83; P = .049)., Conclusion: In this retrospective, pragmatic analysis of patients with moderate or severe mitral regurgitation, admission for heart failure exacerbation, elevated right atrial pressure, renal dysfunction, anemia, and lack of mitral valve intervention were independently associated with increased risk of all-cause mortality. Whether these risk factors may better identify select patients who may benefit from more intensive monitoring or earlier intervention should be considered in future studies., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: To evaluate transcatheter aortic valve replacement (TAVR) operator procedural volumes, and describe temporal and geographic trends., Background: TAVR is the standard of care for most patients with severe symptomatic aortic stenosis. Despite an association between operator procedural volume and outcomes, nationwide TAVR operator volumes have been incompletely described., Methods: We queried the National Medicare Provider Utilization and Payment Database for transfemoral TAVRs from 2014 to 2018. Annual operator volume, state and regional volumes, and longitudinal trends were extracted and analyzed using descriptive statistics., Results: In 2018, the mean annual operator volume was 23.6 TAVRs. The highest 1% of operators by volume performed 7.6% of total TAVR procedures in the United States, while 35.7% of operators performed 10 or fewer TAVRs per year. From 2014 to 2018, there was a 53.9% annualized increase in TAVRs, and the mean annual volume per operator grew from 12.5 to 23.6. There was more than five-fold variability in the density of operators (range 0.35-1.79 operators per 100,000 population) and mean operator volume by state (range 14.2-52.4 TAVRs per operator)., Conclusions: In this nationally representative study of operators performing transfemoral TAVRs among Medicare patients, we found the mean annual volume of TAVR in 2018 to be 23.6 and has increased since 2014. There was considerable variability in operator density and procedural volumes, with a significant proportion of operators performing 10 or fewer TAVRs per year. Ambiguity remains in regard to the optimal balance of procedural requirements to sustain high efficacy outcomes and ensure critical access to TAVR therapies., (© 2022 Wiley Periodicals LLC.)

Microplastics pollution is one of the most pressing environmental problems of the 21st century. While microplastics are pervasive throughout various environmental compartments, research to date has primarily focused on marine systems. Land-based microplastics sources (e.g., solid waste) have received comparatively little attention, although they account for the main flow of microplastics into aquatic environments. Solid waste microplastics sources primarily include landfill refuse, sludge, and food waste. Microplastics in these waste streams can be associated with various micropollutants that can have deleterious impacts on ecosystem health as they enter the food chain. Thus, understanding the occurrence, fate, and degradation pathways of solid waste microplastics is essential to develop comprehensive control and mitigation strategies. This study critically reviewed these key aspects of microplastics in municipal solid waste landfill refuse, sewage sludge, and food waste, and identified the interconnections of these components in the proliferation of microplastics to the environment. Additionally, microplastics related laws and regulations and their relevance to solid waste microplastics mitigation are discussed., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Hypoattenuating leaflet thickening (HALT), the radiographic manifestation of transcatheter heart valve thrombosis, is commonly identified following transcatheter aortic valve replacement (TAVR) and associated with increased risk of stroke and structural valve deterioration. While anticoagulation effectively resolves HALT, routine use remains controversial. We aimed to identify hemodynamic, anatomic, and comorbid predictors of HALT., Methods: We evaluated consecutive patients with severe aortic stenosis who underwent TAVR with Edwards SAPIEN 3 bioprosthesis at a single center between June 1, 2018 and October 30, 2019. Patients on anticoagulation and those receiving valve-in-valve were excluded. Clinically driven computed tomography (CT) imaging was performed to assess for HALT at the discretion of the treating valve team., Results: A total of 78 patients with a mean age of 78 ± 10 years and STS risk score 5.5 ± 3.3% were analyzed. HALT was identified in 11 (14.1%) patients. Compared to controls, those with HALT had smaller annular areas, 435 ± 57 mm 2 vs. 489 ± 79 mm 2 (p = .032), but received comparable size valves. In multivariate regression, valve oversizing by more than 20% was associated with increased risk of HALT, OR 23.5, 95% CI 2.5-223, (p = .006). After initiation of anticoagulation, patients with HALT had similar rates of stroke, major bleeding, and all-cause mortality out to an average of 243 days., Conclusions: In this pragmatic study of patients undergoing TAVR with SAPIEN 3 valves, we report the novel finding that oversizing by more than 20% was independently associated with increased risk of HALT. These findings warrant confirmation in larger and prospective trials., (© 2020 Wiley Periodicals LLC.)

Objectives: We sought to evaluate the efficacy and safety of bivalirudin versus heparin in patients with coronary artery disease undergoing transradial artery coronary intervention (TRI)., Background: Bivalirudin and radial artery access are independently associated with improved cardiovascular outcomes. However, data supporting a strategy of combining both to achieve additive improvements in cardiovascular outcomes provide conflicting results., Methods: A systematic search was performed to identify randomized controlled trials (RCTs) of bivalirudin, in which vascular access sites were reported. The primary outcome was net adverse clinical events (NACE) at 30 days. Secondary outcomes were long-term NACE, short-, and long-term major adverse cardiovascular events, all-cause mortality, myocardial infarction, unplanned revascularization, stent thrombosis, and major bleeding., Results: We identified 10 RCTs, including 16,328 patients who underwent TRI (mean age 64.6 ± 15.7 years, 72.5% male). Bivalirudin use was associated with decreased 30-day NACE compared with heparin (6.3 vs. 7.4%; risk ratio [RR] = 0.87; 95% confidence interval [CI] = 0.76-0.99; p = .04; number needed to treat = 91). No significant interactions were observed based on clinical presentation, administration of P2Y 12 inhibitors, or glycoprotein IIb/IIIa-receptor inhibitors (GPI) use. There were no significant differences between groups in any prespecified secondary outcomes. There was, however, a significant reduction of major bleeding in the bivalirudin group compared with heparin when used in combination with routine GPI (RR = 0.41; 95% CI = 0.19-0.90; p = .03)., Conclusions: Among patients undergoing TRI, use of bivalirudin was associated with significantly reduced 30-day NACE compared with heparin. There was no significant difference in long term NACE, ischemic, or bleeding events compared with heparin., (© 2020 Wiley Periodicals, Inc.)

Among patients who have undergone percutaneous coronary intervention (PCI), the use of dual antiplatelet therapy (DAPT) is associated with increased risk of bleeding, but decreased stent thrombosis and myocardial infarction unrelated to the stent. As PCI techniques and devices have progressed, the optimal duration of DAPT has come into question. We identified all randomized controlled trials (RCTs) of patients undergoing PCI, who received one or more drug eluting stents (DES) for stable coronary artery disease (CAD) or acute coronary syndrome (ACS), and randomized to short (1-3 months) versus standard duration DAPT. The prespecified primary outcome was major adverse cardiovascular events (MACE). Important secondary outcomes were net adverse clinical events (NACE) defined as MACE and major bleeding; any bleeding; major bleeding; all-cause death; cardiovascular death. We calculated hazard ratios (HR) and 95% confidence intervals (CI) using random-effects model. Analysis included 7 RCTs, comprising 35,857 patients and 53,321 patient-years of follow-up. The mean (SD) age of patients was 64.4 (10.6) years, 49.6% of patients presented with ACS, and 25.5% were female. There was no difference between short and standard-length DAPT in regards to MACE (HR = 0.93; 95% CI 0.84-1.03; p = 0.19), NACE (HR = 0.93; 95% CI 0.85-1.02; p = 0.12), all-cause death (HR = 0.92; 95% CI 0.80-1.05; p = 0.21), or cardiovascular death (HR = 0.85; 95% CI 0.64-1.13; p = 0.26). However, short-term DAPT was associated with significantly reduced major bleeding events (HR = 0.67; 95% CI 0.47-0.95; p = 0.03) and any bleeding event (HR = 0.63; 95% CI 0.44-0.90; p = 0.01) compared with standard-length DAPT. Among patients undergoing PCI for CAD, the use of short-term DAPT (1-3 months) followed by single antiplatelet therapy was associated with a lower incidence of clinically relevant bleeding events, but with similar risk of MACE, all-cause death, and cardiovascular death compared with standard duration DAPT.

Background: Cryptogenic stroke and embolic stroke of undetermined source (ESUS) are a frequently encountered categories of ischemic stroke with an uncertain cause., Methods: We analyzed all randomized clinical trials (RCTs) that evaluated antithrombotic therapy and patent foramen ovale (PFO) closure in cryptogenic stroke and/or ESUS. We calculated aggregate hazard ratios (HRs) using direct and network meta-analysis. The primary outcome was recurrent ischemic stroke., Results: Ten RCTs with a total of 16,876 patients, randomizing 32,143 patient-years of follow-up (mean age 61.2 ± 13.5 with 39.2% female) were identified. Anticoagulation therapy was associated with significantly reduced recurrent ischemic stroke compared with antiplatelet therapy (HR = 0.66; [95% confidence interval (CI) = 0.47-0.94]). Meta-regression analysis showed significantly reduced recurrent stroke with longer duration of therapy, and significantly increased events with advanced age. Significant interactions were observed based on the presence of PFO, stroke type, and anticoagulant used. There were no significant differences with regard to the composite ischemic outcome, transient ischemic attack, any death, major bleeding, or intracranial bleeding. In the network meta-analysis, compared to antiplatelet therapy, warfarin (HR = 0.31; [95% credible interval (CrI) = 0.12-0.68]) and PFO closure (HR = 0.14; 95% CrI = 0.05-0.31]) were associated with significantly reduced recurrent ischemic stroke. In rank order, PFO closure was associated with the best outcome, followed by warfarin., Conclusions: Among patients with cryptogenic stroke, anticoagulation therapy, as compared with antiplatelet therapy is associated with lower rate of recurrent stroke. The small sample size and high heterogeneity with regards to bleeding outcomes require further large trials. In patients with PFO, closure and warfarin are associated with the lowest rates of recurrent stroke., Competing Interests: Declaration of competing interest None., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: This study evaluated the efficacy and safety of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) in low surgical risk patients., Methods: An electronic database search was conducted for randomized controlled trials (RCTs). We calculated hazard ratios (HRs) and 95% confidence intervals (CIs) using a random-effects model., Results: Five RCTs were identified with a total of 3,072 patients (mean age 74.5 ± 6.1 and 64.8% male). Compared with SAVR, TAVR was associated with a significantly reduced rate of death or disabling stroke (HR = 0.52; 95% CI = 0.27-0.99; P = .049), atrial-fibrillation (HR = 0.28; 95% CI = 0.18-0.46; P < .01), and post-procedure bleeding (HR = 0.38; 95% CI = 0.31-0.46; P < .01), along with a significantly improved quality-of-life at 1-year. However, TAVR was associated with significantly increased rates of paravalvular leak (HR = 4.09; 95% CI = 1.92-8.69; P < .01) and pacemaker insertion (HR = 2.81; 95% CI = 1.85-4.28; P < .01) compared with SAVR., Conclusion: Among older low-risk patients with severe aortic stenosis, TAVR is associated with a lower rate of death or disabling stroke compared with SAVR. Transcatheter aortic valve replacement is also associated with improved quality-of-life, reduced bleeding and atrial fibrillation, but higher paravalvular leak and pacemaker implantation rates., (Copyright © 2019 Elsevier Inc. All rights reserved.)