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Background: For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking., Methods: At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was performed in the intention-to-treat population., Results: A total of 901 patients underwent randomization; 455 patients were assigned to TAVR and 446 to clinical surveillance. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8% (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after surgery), and 83.6% of patients were at low surgical risk. A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and in 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the patients assigned to clinical surveillance, stroke occurred in 4.2% and 6.7%, respectively, and unplanned hospitalization for cardiovascular causes occurred in 20.9% and 41.7%. During a median follow-up of 3.8 years, 87.0% of patients in the clinical surveillance group underwent aortic-valve replacement. There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who underwent aortic-valve replacement., Conclusions: Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: Right ventricular dysfunction (RVD) complicates 30%-40% of cases in acute myocardial infarction (AMI) and cardiogenic shock (CS). There are sparse data on the effects of RVD on outcomes and the impact of providing early left ventricular (LV) mechanical circulatory support (MCS) on RV function and hemodynamics., Methods and Results: Between July 2016 and December 2020, 80 sites participated in the study. All centers agreed to treat patients with AMI-CS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of LV-MCS. RVD was defined as a right atrial (RA) pressure of >12 mm Hg and a pulmonary artery pulsatility index (PAPI) of <1 within 24 hours of the index procedure. The primary outcome was survival to discharge. In a subgroup analysis, data available from the Automated Impella Controller console was used to analyze diastolic suction alarms from LV placement signal and its relation to RVD. A total of 361 patients were included in the analysis, of whom 28% had RVD. The median age was 64 years (interquartile range 55-72 years), 22.7% were female and 75.7% were White. There was no difference in age, sex, or comorbidities between those with or without RVD. Patients with RVD had a higher probability of active CPR during LV-MCS implant (14.7% vs 6.3%), Society for Cardiovascular Angiography and Interventions stage E shock (39.2% vs 23.2%), and higher admission lactate levels (5.1 mg/dL vs 3.0 mg/dL). Survival to discharge was significantly lower among those with RVD (61.8% vs 73.4%, odds ratio 0.89, 95% confidence interval 0.36-0.95, P = .031). This association remained significant in the multivariate analysis. There was no significant difference in hemodynamic variables within 24 hours of LV-MCS support among those with or without RVD. At 24 hours, patients with a CPO of >0.6 W and a PAPi of >1 had a trend toward better survival to discharge compared with those with a CPO of ≤0.6 W and a PAPi of ≤1 (77.1% vs 54.6%, P = .092). Patients with RVD were significantly more likely to have diastolic suction alarms within 24 hours of LV-MCS initiation., Conclusions: RVD in AMI-CS is common and associated with worse survival to discharge. Early LV-MCS decreases filling pressures rapidly within the first 24 hours and decreases the rate of RVD. Achieving a CPO of >0.6 W and a PAPi of >1 within 24 hours is associated with high survival. Diastolic suction alarms may have usefulness as an early marker of RVD., Competing Interests: Disclosures Dr. Tedford reports no direct conflicts of interest related to this manuscript. He reports general disclosures to include consulting relationships with Abbott, Acorai, Aria CV Inc., Acceleron/Merck, Alleviant, CareDx, Cytokinetics, Edwards LifeSciences, Gradient, Lexicon Pharmaceuticals, Medtronic, and United Therapeutics. Dr. Tedford serves on steering committee for Merck, Edwards, and Abbott, as well as a research advisory board for ​Abiomed. He also does hemodynamic core lab work for Merck. Dr. Cowger is a paid consultant/advisor for Abbott, Inc (HeartMate 3 LVAD; tendyne and cephea valve trials), Medtronic (HVAD study), Bioventrix, CorWave, and Procyrion (Aortix device). She is an unpaid steering committee member for Endotronix (Cordella PA sensor) and Nuwellis. She is on the DSMB for BiVACOR and Berlin Heart Excor device trials. She is a speaker for Zoll, Abbott, and Bioventrix., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Harmful Algal Blooms (HABs) are outbreaks of aquatic toxic microalgae emerging as a global problem driven by nutrient enrichment, global climate change and invasive species. We uniquely describe a HAB of unprecedented duration, extent and magnitude during 2023 in Lough Neagh; the UK and Ireland's largest freshwater lake, using an unparalleled combination of satellite imagery, nutrient analysis, 16S rRNA gene sequencing and cyanotoxin profiling. The causative agent Microcystis aeruginosa accounted for over a third of DNA in water samples though common bacterioplankton species also bloomed. Water phosphate levels were hypertrophic and drove local algal biomass. The HAB pervaded the entire ecosystem with algal mats accumulating around jetties, marinas and lock gates. Over 80 % of bacterial DNA isolated from algal mat samples consisted of species associated with wildfowl or livestock faeces and human-effluent wastewater including 13 potential pathogens that can cause serious human illness including: E. coli, Salmonella, Enterobacter and Clostridium among others. Ten microcystins, nodularin and two anabaenopeptin toxins were confirmed as present (with a further microcystin and four anabaenopeptins suspected), with MC-RR and -LR in high concentrations at some locations (1,137-18,493 μg/L) with MC-LR exceeding World Health Organisation (WHO) recreational exposure guidelines in all algal mats sampled. This is the first detection of anabaenopeptins in any waterbody on the island of Ireland. Notwithstanding the ecological impacts, this HAB represented an environmental and public health risk, curtailing recreational activities in-and-around the lake and damaging local businesses. Reducing agricultural runoff and discharge from human-effluent wastewater treatment to manage nutrient loading, and the public health risk, should be the top priority of stakeholders, especially government. Key recommendations include Nature-based Solutions that avoid conflict with the productivity and profitability of the farming sector enhancing sustainability. We hope this stimulates real-world action to resolve the problems besetting this internationally important ecosystem., Competing Interests: Declaration of competing interest 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., (Copyright © 2024. Published by Elsevier Ltd.)

Background: Utilization of right ventricular mechanical circulatory support (RV-MCS) devices has been limited by a lack of recognition of RV failure as well as a lack of availability and experience with RV-MCS., Aims: We report a single-center experience with the use of percutaneous RV-MCS and report predictors of adverse outcomes., Methods: This was a single-center retrospective cohort study. Data from consecutive patients who received RV-MCS for any indication between June 2015 and January 2022 were included. Data on baseline comorbidities, hemodynamics, and laboratory values were collected. The primary outcome was in-hospital mortality analyzed as a logistic outcome in a multivariable model. These variables were further ranked by their predictive value., Results: Among 58 consecutive patients enrolled, the median age was 66 years, 31% were female and 53% were white. The majority of the patients (48%) were hospitalized for acute on chronic heart failure. The majority of the patients were SCAI SHOCK Stage D (67%) and 34 (64%) patients had MCS placed within 24 h of the onset of shock. Before placement of RV-MCS, median central venous pressure (CVP) and RV stroke work index were 20 mmHg and 8.9 g m/m 2 , respectively. Median serum lactate was 3.5 (1.6, 6.2) mmol/L. Impella RP was implanted in 50% and ProtekDuo in the remaining 50%. Left ventricular MCS was concomitantly used in 66% of patients. Twenty-eight patients (48.3%) died. In these patients, median serum lactate was significantly higher (4.1 [2.3, 13.0] vs. 2.2 [1.4, 4.0]  mmol/L, p = 0.007) and a trend toward higher median CVP (24 [18, 31] vs. 19 [14, 24] mmHg, p = 0.052). In the multivariable logistic model, both serum lactate and CVP before RV-MCS placement were independent predictors of in-hospital mortality. Serum lactate had the highest predictive value., Conclusion: In our real-world cohort, 52% of patients treated with RV-MCS survived their index hospitalization. Serum lactate at presentation and CVP were the strongest predictors of in-hospital mortality., (© 2024 Wiley Periodicals LLC.)

Ultrasonography is increasingly being performed by clinicians at the point of care, and nephrologists are no exception. This Core Curriculum illustrates how ultrasonography can be incorporated into clinical decision making across the spectrum of kidney disease to optimize the care nephrologists provide to patients. Sonography is valuable in outpatient and inpatient settings for the diagnosis and management of acute and chronic kidney disease, evaluation of cystic disease, urinary obstruction, pain, hematuria, proteinuria, assessment of volume status, and in providing guidance for kidney biopsy. As kidney disease advances, ultrasound is useful in the placement and maintenance of temporary and permanent access for dialysis. After kidney transplantation, ultrasonography is critical for evaluation of allograft dysfunction and for biopsies. Sonography skills expedite patient care and enhance the practice of nephrology and are relatively easily acquired with training. It is our hope that this curriculum will encourage nephrologists to learn and apply this valuable skill., (Copyright © 2023 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: There has been a significant increase in the utilization of venoarterial extracorporeal membrane oxygenation (VA-ECMO) in recent years. Cardiothoracic surgery teams have historically led VA-ECMO care teams, with little data available on alternative care models., Methods: We performed a retrospective review of a cardiovascular medicine inclusive VA-ECMO service, analyzing patients treated with peripheral VA-ECMO at a large quaternary care center from 2018 to 2022. The primary outcome was death while on VA-ECMO or within 24 hours of decannulation. Univariate and multivariate analyses were used to identify predictors of the primary outcome., Results: Two hundred forty-four patients were included in the analysis (median age 61 years; 28.7% female), of whom 91.8% were cannulated by interventional cardiologists, and 84.4% were managed by a cardiology service comprised of interventional cardiologists, cardiac intensivists or advanced heart failure cardiologists. Indications for VA-ECMO included acute myocardial infarction (34.8%), decompensated heart failure (30.3%), and refractory cardiac arrest (10.2%). VA-ECMO was utilized during cardiopulmonary resuscitation in 26.6% of cases, 48% of which were peri-procedural arrest. Of the patients, 46% survived to decannulation, the majority of whom were decannulated percutaneously in the cardiac catheterization laboratory. There was no difference in survival following cannulation by a cardiac surgeon vs interventional cardiologist (50% vs 45%; P = .90). Complications included arterial injury (3.7%), compartment syndrome (4.1%), cannulation site infection (1.2%), stroke (14.8%), acute kidney injury (52.5%), access site bleeding (16%) and need for blood transfusion (83.2%). Elevated baseline lactate (odds ratio [OR], 1.13 per unit increase) and sequential organ failure assessment score (OR, 1.27 per unit increase) were independently associated with the primary outcome. Conversely, an elevated baseline survival after VA ECMO score (OR, 0.92 per unit increase) and 8-hour serum lactate clearance (OR, 0.98 per % increase) were independently associated with survival., Conclusions: The use of a cardiovascular medicine inclusive ECMO service is feasible and may be practical in select centers as indications for VA-ECMO expand., (© 2024 The Author(s).)

Background: There is no clear consensus regarding the optimal risk stratification of high-degree atrioventricular block (HDAVB) after transcatheter aortic valve replacement (TAVR)., Methods: This prospective study sought to determine the utility of the pre- and post-TAVR His-ventricular (HV) interval in the risk stratification of post-TAVR HDAVB. One hundred twenty-one patients underwent an electrophysiology study before and after TAVR. The primary outcome was HDAVB requiring pacemaker implantation within 30 days post-TAVR. A separate retrospective cohort was analyzed to determine the postoperative interval at which the risk of HDAVB is reduced to <5%., Results: HDAVB occurred in 12 (10%) patients. Baseline right bundle branch block (RBBB) (odds ratio [OR]: 13.6), implant depth >4 mm (OR: 3.9), use of mechanically- or self-expanding valves (OR: 6.3), and post-TAVR HV > 65 ​ms (OR: 4.9) were associated with increased risk of HDAVB, whereas PR intervals and pre-TAVR HV were not. In patients without baseline RBBB or new persistent left bundle branch block (LBBB), not one patient with post-TAVR HV < 65 ​ms developed HDAVB. In the separate retrospective cohort (N = 1049), the risk of HDAVB is reduced (<5%) on postoperative days 4 and 3 in patients with pre-TAVR RBBB and post-TAVR persistent LBBB, respectively., Conclusions: Baseline RBBB, new persistent LBBB, implant depth >4 mm, and a post-TAVR HV ≥ 65 ​ms were associated with a higher risk of post-TAVR HDAVB, whereas an HV ≤ 65 ​ms was associated with a lower risk. The pre-TAVR HV was not associated with our outcome, and the delta HV did not have practical incremental prognostic value. Among those without pre-TAVR RBBB or post-TAVR persistent LBBB, no patients with post-TAVR HV < 65 ​ms developed HDAVB., Competing Interests: P. Villablanca is a consultant for Edwards LifeSciences and Teleflex. D. D. Wang is a consultant for Abbott, Boston Scientific, and Edwards LifeSciences. D. D. Wang receives research grant support from Boston Scientific assigned to her employer, Henry Ford Health. B. O'Neill is a consultant to Abbott, Edwards LifeSciences, and Medtronic and receives research support from Edwards LifeSciences assigned to his employer, Henry Ford Health. T. Frisoli is a clinical proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. W. O'Neill is a consultant to Abiomed, Medtronic, and Boston Scientific. The other authors had no conflicts to declare., (© 2024 Published by Elsevier Inc. on behalf of Cardiovascular Research Foundation.)

Background: The Society for Cardiovascular Angiography and Interventions proposed a staging system (A-E) to predict prognosis in cardiogenic shock. Herein, we report clinical outcomes of the RECOVER III study for the first time, according to Society for Cardiovascular Angiography and Interventions shock classification., Methods and Results: The RECOVER III study is an observational, prospective, multicenter, single-arm, postapproval study of patients with acute myocardial infarction with cardiogenic shock undergoing percutaneous coronary intervention with Impella support. Patients enrolled in the RECOVER III study were assigned a baseline Society for Cardiovascular Angiography and Interventions shock stage. Staging was then repeated within 24 hours after initiation of Impella. Kaplan-Meier survival curve analyses were conducted to assess survival across Society for Cardiovascular Angiography and Interventions shock stages at both time points. At baseline assessment, 16.5%, 11.4%, and 72.2% were classified as stage C, D, and E, respectively. At ≤24-hour assessment, 26.4%, 33.2%, and 40.0% were classified as stage C, D, and E, respectively. Thirty-day survival among patients with stage C, D, and E shock at baseline was 59.7%, 56.5%, and 42.9%, respectively ( P =0.003). Survival among patients with stage C, D, and E shock at ≤24 hours was 65.7%, 52.1%, and 29.5%, respectively ( P <0.001). After multivariable analysis of impact of shock stage classifications at baseline and ≤24 hours, only stage E classification at ≤24 hours was a significant predictor of mortality (odds ratio, 4.8; P <0.001)., Conclusions: In a real-world cohort of patients with acute myocardial infarction with cardiogenic shock undergoing percutaneous coronary intervention with Impella support, only stage E classification at ≤24 hours was significantly predictive of mortality, suggesting that response to therapy may be more important than clinical severity of shock at presentation.

Background: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC)., Objectives: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients., Methods: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT., Results: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02)., Conclusions: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT., Competing Interests: Funding Support and Author Disclosures Dr Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions (Laval University, Quebec City, Canada). He also has received institutional research grants from Boston Scientific. Dr Maarse has received an unrestricted grant from Boston Scientific. Dr Pérez de Prado has served as a proctor for Boston Scientific. Dr Gupta has served as a proctor for Abbott. Dr Sanchez has served as a speaker and proctor for Boston Scientific. Dr Wang has served as a consultant for Edwards Lifesciences, Boston Scientific, and Neochord; and received research grant support from Boston Scientific assigned to his employer, the Henry Ford Health System. Dr Demkow has served as a proctor for Abbott and Boston Scientific. Dr Alkhouli has served as a consultant for Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve-in-mitral annular calcification (ViMAC)., Objectives: The aim of this study was to evaluate 5-year outcomes among these patients., Methods: A multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories., Results: A total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled., Conclusions: MViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality., Competing Interests: Funding Support and Author Disclosures This study was partially supported by an unrestricted research grant from Edwards Lifesciences. The authors had absolute control over the study design, data collection, analysis and interpretation of data, and writing of this manuscript, and they take full responsibility for the findings. Dr Guerrero has received institutional research grant support from Edwards Lifesciences; and has served as consultant for Abbott Structural Heart and Medtronic. Dr Wang is a consultant for Abbott, Boston Scientific, Edwards Lifesciences, Materialise, and NeoChord. She also receives research grant support from Boston Scientific assigned to her employer Henry Ford Hospital. Dr Tang is a physician proctor and consultant for Medtronic; is a consultant and physician advisory board member for Abbott Structural Heart; and is a consultant for NeoChord. Dr McCabe has received honoraria from Boston Scientific, Cardiovascular Systems, Edwards Lifesciences, and Medtronic. Dr Whisenant has received consulting and speaker fees from Edwards Lifesciences. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and is chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Rihal has received institutional research grant support from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: High-flow nasal cannula oxygen therapy (HFNC) is increasingly used to treat bronchiolitis. However, HFNC has not reduced time on supplemental oxygen, length of stay (LOS), or ICU admission. Our objective was to reduce HFNC use in children admitted for bronchiolitis from 41% to 20% over 2 years., Methods: Using quality improvement methods, our multidisciplinary team formulated key drivers, including standardization of HFNC use, effective communication, knowledgeable staff, engaged providers and families, data transparency, and high-value care focus. Interventions included: (1) standardized HFNC initiation criteria, (2) staff education, (3) real-time feedback to providers, (4) a script for providers to use with families about expectations during admission, (5) team huddle for patients admitted on HFNC to discuss necessity, and (6) distribution of a bronchiolitis toolkit. We used statistical process control charts to track the percentage of children with bronchiolitis who received HFNC. Data were compared with a comparison institution not actively involved in quality improvement work around HFNC use to ensure improvements were not secondary to the COVID-19 pandemic alone., Results: Over 10 months of interventions, we saw a decrease in HFNC use for patients admitted with bronchiolitis from 41% to 22%, which was sustained for >12 months. There was no change in HFNC use at the comparison institution. The overall mean LOS for children with bronchiolitis decreased from 60 to 45 hours., Conclusions: We successfully reduced HFNC use in children with bronchiolitis, improving delivery of high-value and evidence-based care. This reduction was associated with a 25% decrease in LOS., (Copyright © 2023 by the American Academy of Pediatrics.)

Background/purpose: Percutaneous valve interventions for aortic stenosis (AS) include transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV). Intraprocedural mechanical circulatory support (MCS) with Impella devices (Abiomed, Danvers, MA) is used in select high-risk patients, although data regarding its efficacy is limited. This study sought to evaluate the clinical outcomes of Impella use in patients with AS who underwent TAVR and BAV at a quaternary-care center., Methods/materials: All patients with severe AS who underwent TAVR and BAV with Impella between 2013 and 2020 were included. Patient demographics, outcomes, complications, and 30-day mortality data was analyzed., Results: Over the study period 2680 procedures were performed, 1965 TAVR and 715 BAV. 120 utilized Impella support, 26 TAVR and 94 BAV. Among TAVR Impella cases, justifications for MCS included cardiogenic shock (53.9 %), cardiac arrest (19.2 %), and coronary occlusion (15.4 %). Among BAV Impella cases, justifications for MCS included cardiogenic shock (55.3 %) and protected percutaneous coronary intervention (43.6 %). The 30-day mortality rate in TAVR Impella was 34.6 % and in BAV Impella was 28 %. BAV Impella cases involving cardiogenic shock had a higher rate of 45 %. Impella remained in-use past 24 h from the procedure in 32.2 % cases. Vascular access-related complications occurred in 4.8 % cases and bleeding complications occurred in 1.5 % cases. Conversion to open-heart surgery occurred in 0.7 % cases., Conclusions: MCS is an option for high-risk patients with severe AS who require TAVR and BAV. Despite hemodynamic support, the 30-day mortality rate remained high especially in cases where support was employed for cardiogenic shock., Competing Interests: Declaration of competing interest None., (Copyright © 2023. Published by Elsevier Inc.)

Background: Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution., Objectives: The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR., Methods: Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates., Results: Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001)., Conclusions: The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year. (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study [CLASP TR EFS]; NCT03745313)., Competing Interests: Funding Support and Author Disclosures This study was funded by Edwards Lifesciences. Dr Kodali has served as a consultant for Admedus, TriCares, TriFlo, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, and Moray Medical; has served as an advisory board member for Dura Biotech, Thubrikar Aortic Valve, Philips, Medtronic, and Boston Scientific; and has received institutional grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has received institutional consulting contracts, for which she has received no direct compensation, from Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has held stock options with Navigate; and has served as Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she has received no direct industry compensation. Dr Davidson has received research grant funding from Edwards Lifesciences; and has served as a consultant for Edwards Lifesciences. Dr Greenbaum has received proctor honoraria from Edwards Lifesciences. Dr Zahr has served as a consultant for Medtronic and Edwards Lifesciences. Dr Chadderdon has served as a consultant for Edwards Lifesciences and Medtronic. Dr Smith has received institutional grant support from Edwards Lifesciences, Abbott, and Artivion; has served as a speaker for Edwards Lifesciences, Abbott, Artivion, and Medtronic; and has served on the advisory board for Edwards Lifesciences. Dr Grayburn has received research grants from Abbott, Edwards Lifesciences, Medtronic, W.L. Gore & Associates, Neochord, and Cardiovalve; and has served as a consultant or on the advisory board for Abbott, Edwards Lifesciences, Medtronic, and 4C Medical. Dr. Marcoff has served as a member of a cardiovascular core laboratory that has contracts with Edwards Lifesciences and Abbott, for which he has received no direct compensation. Dr Whisenant has served as a consultant for Edwards Lifesciences. Dr Makkar has received research grants from Abbott and Edward Lifesciences; and has served as a consultant for Cordis and Medtronic. Dr Makar has served as a consultant for Abbott Vascular and Boston Scientific. Dr O’Neill has served as a consultant for Edwards Lifesciences. Dr Wang has served as a consultant for Edwards Lifesciences, Abbott Vascular, Boston Scientific, Materialise, and Neochord; and has received research grant support from Boston Scientific assigned to employer Henry Ford Health System. Dr Gray has served as a consultant for Edwards Lifesciences. Dr Hermiller has served as a consultant for Edwards Lifesciences. Dr Mitchel has received echocardiography education with Abbott. Dr Lim has received institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting fees from Venus Medtech and W.L. Gore & Associates. Dr Williams has received research funding from Edwards Lifesciences and Medtronic. Dr Mack has served as a co-principal investigator for Edwards Lifesciences and Abbott trials; and has served as a study chair for Medtronic. Dr Leon has received instructional research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

When the Grand Final of the Australian Football League (AFL) was played at the Brisbane Cricket Ground (the Gabba) in October 2020, small rolls of turf from Victoria were laid at the three player entrances. This turf was infested with southern sting nematode ( Ibipora lolii ) and so it was removed, the infested sites were fumigated, and nematicides were applied in an attempt to eliminate the nematode. Results published in September 2021 indicated that this appeared to have been successful, as I. lolii was not detected in a post-treatment monitoring program. This paper reports results from an ongoing monitoring program which show that the eradication program was ineffective. Consequently, the Gabba is currently the only Queensland location known to be infested with I. lolii . The paper finishes by listing the biosecurity issues that should be addressed to prevent further spread of the nematode., Competing Interests: Conflict of interestThe authors declare that they have no conflict of interest., (© The Author(s) under exclusive licence to Australasian Plant Pathology Society Inc. 2023.)

Background: Hemodialysis solutions typically contain a high alkali concentration designed to counter interdialytic acidosis, but this could result in persistent alkalosis in some patients. The prevalence and significance of persistent alkalosis were therefore examined at four outpatient centers over a 10-year period., Methods: Alkalosis was defined as a pre-dialysis serum [HCO 3 ] ≥ 26 meq/L in >6 months of a 12-month period and was persistent if present in a majority of months thereafter. Control patients had a serum [HCO 3 ] of 19-23 meq/L > 6 of every 12 months. Standard, citrate-containing dialysate was used in all patients without adjustment of bicarbonate concentration., Results: 444 of 1271 patients had alkalosis that persisted in 73. Compared to control patients, persistently alkalotic patients were older, but gender, race, starting weight, comorbidities, and mortality did not differ. Dialysis dose was 7% greater, protein catabolic rate was 11% lower, and interdialytic weight gain was 29% lower, all p < 0.001. Persistently alkalotic patients had double the incidence of cardiac arrhythmias (p = 0.07) and a 20% greater intradialytic blood pressure decrease (p < 0.001)., Conclusions: Alkalosis is common in hemodialysis patients and can be persistent, likely due to decreased protein catabolic rate and increased dialysis dose, and may have detrimental cardiovascular effects., (© 2022 Wiley Periodicals LLC.)

Background: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study for valve-in-mitral annular calcification (ViMAC), mitral valve-in-ring (MViR), and mitral valve-in-valve (MViV) using balloon-expandable aortic transcatheter heart valves. Procedural outcomes beyond 1 year are not well described., Objectives: This study evaluated 2-year outcomes in ViMAC, MViR, and MViV in the MITRAL trial., Methods: This multicenter prospective study enrolled patients with severe MAC, prior failed mitral annuloplasty ring repair, or prior failed bioprosthetic MV replacement who were at high surgical risk at 13 U.S. sites., Results: Between February 1, 2015, and December 31, 2017, 91 patients were enrolled (31 with ViMAC, 30 with MViR, and 30 with MViV). In the ViMAC group, 2-year all-cause mortality was 39.3%, 66.7% were New York Heart Association (NYHA) functional class I-II, and mean MV gradient was 5.6 ± 2.0 mm Hg. In the MViR group, 2-year all-cause mortality was 50%, 65% were NYHA functional class I-II, and mean MV gradient was 6.5 ± 2.7 mm Hg. In the MViV group, 2-year all-cause mortality was 6.7%, 85% were NYHA functional class I-II, and mean MV gradient was 6.9 ± 2.4 mm Hg. At 2 years, all patients had ≤mild mitral regurgitation and survivors in all 3 arms showed sustained improvement in Kansas City Cardiomyopathy Questionnaire scores compared to baseline., Conclusions: Use of balloon-expandable aortic transcatheter heart valves in selected patients with severe MAC, failed annuloplasty ring, and bioprosthetic MV dysfunction is associated with improvements in symptoms, quality of life, and stable prosthesis function at 2-year follow-up. Between 1 and 2 years, the MViR group experienced higher mortality rates than the MViV and ViMAC groups., Competing Interests: Funding Support and Author Disclosures This study was supported by an unrestricted research grant from Edwards Lifesciences. Dr Wang has served as a consultant for Abbott, Boston Scientific, Edwards Lifesciences, Materialise, and NeoChord; and has received research grant support from Boston Scientific assigned to her employer Henry Ford Hospital. Dr Tang has served as a physician proctor and consultant for Medtronic; has served as a consultant and physician advisory board member for Abbott Structural Heart; and has served as a consultant for NeoChord. Dr McCabe has received honoraria from Boston Scientific, CSI, Edwards, and Medtronic. Dr Whisenant has received consulting and speaker fees from Edwards Lifesciences. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has stock options with Navigate; and has served as Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she has received no direct industry compensation. Dr Guerrero has received institutional research grant support from Edwards Lifesciences; and has served as a consultant for Abbott Structural Heart and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: Acute MR due to mechanical mitral valve (MV) complications frequently results in cardiogenic shock and requires emergency surgical intervention. There was limited evidence for alternative treatment like MitraClip for patients at prohibitive surgical risk. We aimed to study the technical features and outcomes of emergency transcatheter edge-to-edge repair (TEER) using the MitraClip system for patients with cardiogenic shock (CS) secondary to acute mitral regurgitation (MR) and mechanical MV complication., Material and Methods: We performed institutional review and systemic literature review to identify all TEER for CS patients due to acute mitral regurgitation and mechanical MV complication. Clinical endpoints included device success rate assessed at the end of procedure, ability to wean off MCS, all-cause and cardiovascular mortality at 30-day., Results: Eight patients were identified from institutional review. Detail anatomical analysis found that patients with mechanical MV complications related to myocardial infarction had a lower transseptal height achieved during MitraClip (3.6 ± 0.1 cm vs 4.3 ± 0.3 cm, p = 0.03) than those not related. Pooled analysis for cases from institutional review (n = 8) and systemic literature review (n = 16) was performed. The device success rate was 68.8 %. Seventy-five percent (n = 18) cases required mechanical circulatory support (MCS), and 94.4 % were able to wean off MCS. At 30-day, the cardiovascular mortality was 4.5 % and the all-cause mortality was 9.1 %., Conclusions: In CS patients due to acute MR and mechanical MV complications, TEER with/without MCS was feasible with a reasonable device success rate., Competing Interests: Declaration of competing interest Dr. Frisoli is a clinical proctor for Abbott. Dr. O'Neill is a consultant to Abiomed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Veno-arterial extracorporeal membrane oxygenation is used in patients requiring biventricular support; however, its use increases the afterload. In patients with severe aortic insufficiency or severe left ventricular disfunction, it will increase left-side filling pressures, hence the need for left ventricle unloading with an additional mechanical circulatory support device. We present a case of a patient with cardiogenic shock and severe aortic insufficiency who underwent left atrial veno-arterial extracorporeal membrane oxygenation and provide a step-by-step explanation of the technique., (© 2022 The Author(s).)

Background and Objectives: Point-of-care ultrasound (POCUS)-performed by a clinician during a patient encounter and used in patient assessment and care planning-has many potential applications in nephrology. Yet, US nephrologists have been slow to adopt POCUS, which may affect the training of nephrology fellows. This study sought to identify the current state of POCUS training and implementation in nephrology fellowships., Design, Setting, Participants, & Measurements: Concise survey instruments measuring attitudes toward POCUS, its current use, fellow competence, and POCUS curricula were disseminated to ( 1 ) 912 US nephrology fellows taking the 2021 Nephrology In-Training Examination and ( 2 ) 229 nephrology training program directors and associate program directors. Fisher exact, chi-squared, and Wilcoxon rank sum tests were used to compare the frequencies of responses and the average responses between fellows and training program directors/associate program directors when possible., Results: Fellow and training program directors/associate program directors response rates were 69% and 37%, respectively. Only 38% of fellows (240 respondents) reported receiving POCUS education during their fellowship, and just 33% of those who did receive POCUS training reported feeling competent to use POCUS independently. Similarly, just 23% of training program directors/associate program directors indicated that they had a POCUS curriculum in place, although 74% of training program directors and associate program directors indicated that a program was in development or that there was interest in creating a POCUS curriculum. Most fellow and faculty respondents rated commonly covered POCUS topics-including dialysis access imaging and kidney biopsy-as "important" or "very important," with the greatest interest in diagnostic kidney ultrasound. Guided scanning with an instructor was the highest-rated teaching strategy. The most frequently reported barrier to POCUS program development was the lack of available instructors., Conclusions: Despite high trainee and faculty interest in POCUS, the majority of current nephrology fellows are not receiving POCUS training. Hands-on training guided by an instructor is highly valued, yet availability of adequately trained instructors remains a barrier to program development., Podcast: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2022&#95;09&#95;21&#95;CJN01850222.mp3., (Copyright © 2022 by the American Society of Nephrology.)

Introduction: The timing of hemodynamic support in acute myocardial infarction complicated by cardiogenic shock (AMICS) has yet to be defined. The aim of this meta-analysis was to evaluate the impact of timing of Impella initiation on early and midterm mortality., Methods: A systematic literature review and meta-analysis was conducted using PubMed and Cochrane databases. All studies reporting short-term mortality rates and timing of Impella placement in AMICS were included. Meta-regression analysis and sensitivity analysis were performed on the primary endpoint, short-term mortality (≤30 days), and secondary endpoints (midterm mortality, device-related bleeding, and limb ischemia)., Results: Of 1289 studies identified, 13 studies (6810 patients; 2970 patients identified as receiving Impella pre-PCI and 3840 patients receiving Impella during/post-PCI) were included in this analysis. Median age was 63.8 years (IQR 63-65.7); 76% of patients were male, and a high prevalence of cardiovascular risk factors was noted across the entire population. Short-term mortality was significantly reduced in those receiving pre-PCI vs. during/post-PCI Impella support (37.2% vs 53.6%, RR 0.7; CI 0.56-0.88). Midterm mortality was also lower in the pre-PCI Impella group (47.9% vs 73%, RR 0.81; CI 0.68-0.97). The rate of device-related bleeding (RR 1.05; CI 0.47-2.33) and limb ischemia (RR 1.6; CI 0.63-2.15) were similar between the two groups., Conclusion: This analysis suggests that Impella placement prior to PCI in AMICS may have a positive impact on short- and midterm mortality compared with post-PCI, with similar safety outcomes. Due to the observational nature of the included studies, further studies are needed to confirm this hypothesis (CRD42022300372)., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Several studies have pair-wise compared access sites for transcatheter aortic valve replacement (TAVR) but pooled estimate of overall comparative efficacy and safety outcomes are not well known. We sought to compare short- and long-term outcomes following various alternative access routes for TAVR., Methods: Thirty-four studies with a pooled sample size of 32,756 patients were selected by searching PubMed and Cochrane library databases from inception through 11th June 2021 for patients undergoing TAVR via 1 of 6 different access sites: Transfemoral (TF), Transaortic (TAO), Transapical (TA), Transcarotid (TC), Transaxillary/Subclavian (TSA), and Transcaval (TCV). Data were extracted to conduct a frequentist network meta-analysis with a random-effects model using TF access as a reference group., Results: Compared with TF, both TAO [RR 1.91, 95% CI (1.46-2.50)] and TA access [RR 2.12, 95% CI (1.84-2.46)] were associated with an increased risk of 30-day mortality. No significant difference was observed for stroke, myocardial infarction, major bleeding, conversion to open surgery, and major adverse cardiovascular or cerebrovascular events at 30 days between different accesses. Major vascular complications were lower in TA [RR 0.43, (95% CI, 0.28-0.67)] and TC [RR 0.51, 95% CI (0.35-0.73)] access compared to TF. The 1-year mortality was higher in TAO [RR of 1.35, (95% CI, 1.01-1.81)] and TA [RR 1.44, (95% CI, 1.14-1.81)] groups., Conclusion: Non-thoracic alternative access site utilization for TAVR implantation (TC, TSA and TCV) is associated with outcomes similar to conventional TF access. Thoracic TAVR access (TAO and TA) translates into increased short and long-term mortality., Competing Interests: Declaration of competing interest Adnan K. Chhatriwalla: Speakers Bureau: Abbott Vascular, Edwards Lifesciences, Medtronic Inc.; Proctor: Edwards Lifesciences, Medtronic Inc.; Consultant: Boston Scientific, Silk Road Medical; Research Grant: Boston Scientific. Keith B. Allen: Institutional Research/Grant support: Edwards, Abbott, Medtronic, Boston Scientific; Speakers Bureau: Edwards Lifesciences, Medtronic Inc.; Proctor: Edwards Lifesciences, Medtronic Inc.; Consultant: Abbott, Edwards, Medtronic, Boston Scientific; (all payments are to the institution and none to me personally)., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: The role of vitamin D in increased mortality with SARS-COV-2 virus, namely, COVID-19, remains uncertain. We analysed all the patients who were treated as COVID-19-positive with or without a positive swab and were tested for vitamin D levels., Methods: This was a retrospective, study involving 1226 patients swabbed for SARS-CoV-2 between the 10 February 2020 and 1 May 2020 at two hospitals of East Sussex Healthcare NHS Trust. Patients who were swab-positive for COVID-19 or treated as COVID-19-positive on clinical grounds even though swab results were negative were included in this study. We analysed the association of vitamin D levels and mortality, assessing linear and non-linear associations., Results: A total of 1226 patients had SARS-CoV-2 RNA swabs in this period with age range from 1 year to 101 years. A cohort of 433 of these patients had swabs and recent vitamin D levels anytime in the previous 3 months. Mortality rates were not found to be associated with vitamin D levels (OR=1.04, 95% CI 0.96 to 1.12)., Conclusion: Our findings suggest similar mortality risk from COVID-19 irrespective of the levels of vitamin D. Larger prospective studies will be needed to confirm these findings., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To identify predictors of overall survival (OS) in oropharyngeal squamous cell carcinoma (OPSCC) patients who achieved complete response (CR)., Methods: We performed a retrospective study of OPSCC patients who achieved CR from a single academic medical center. Associations between OS, AJCC 8th edition staging system, definitive treatment choice, smoking history, and p16 status were assessed., Results: p16+ status was associated with favorable prognosis for CR (p < 0.001) but not non-CR (p = 0.67) patients. For early stage, p16+ OPSCC patients who achieved CR, surgery + adjuvant radiation (RT) treatment was more durable compared to concurrent chemoradiation (CRT), particularly in smokers., Conclusions: Curative intent treatment choice and smoking history has an impact on the long-term OS of the CR p16+ OPSCC cohort. Prospective studies to define the optimal multi-modality treatment option to manage p16+ OPSCC patients is needed., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Mechanical circulatory support (MCS) devices are increasingly used for hemodynamic support in cardiogenic shock or high-risk percutaneous coronary interventions. Vascular complications remain a major source of morbidity and mortality despite technological advances with percutaneous techniques. Little is known about the rates and predictors of vascular complications with large-bore access MCS in the contemporary era., Methods: The study cohort was derived from National Inpatient Sample using data from 2015 to 2019 for cardiac hospitalizations with the use of: intra-aortic balloon pump (IABP) Impella, and/or extracorporeal membrane oxygenation (ECMO). The rates of vascular complications and in-hospital outcomes were analyzed using multivariable logistic regression., Results: Of 221,700 hospitalizations with MCS use, the majority had only IABP (68%). The rates of vascular complications were greatest with ECMO (15.8%) when compared with IABP (3.0%) and Impella (5.6%). Among patients with vascular complications, in-hospital mortality was higher with ECMO (56.3%) when compared with IABP (26.2%) and Impella (33.8%). Peripheral arterial disease (PAD) was the strongest predictor of vascular complications, with 10 times higher odds when present (adjusted odds ratio [aOR] 10.96, p < 0.001). In risk-adjusted models, when compared with IABP, the use of Impella (aOR: 1.73, p < 0.001), ECMO (aOR: 5.35, p < 0.001), or a combination of MCS devices (aOR: 3.47, p < 0.001) was associated with higher odds of vascular complications., Conclusions: In contemporary practice, the use of MCS is associated with significant vascular complications and in-hospital mortality. Predictors of vascular complications include larger arteriotomy size, female gender, and peripheral arterial disease. Vascular access management remains essential to prevent major complications., (© 2022 Wiley Periodicals LLC.)

Objectives: To assess the impact of pulmonary hypertension (PH) on outcomes of patients with severe mitral annular calcification (MAC) undergoing transcatheter mitral valve replacement (TMVR)., Background: PH is associated with poor outcomes after mitral valve surgery. Whether the presence of PH in patients with MAC undergoing (TMVR) is associated with poor outcomes, is unknown., Methods: Retrospective evaluation of 116 patients from 51 centers in 11 countries who underwent TMVR with valve in mitral annular calcification (ViMAC) using balloon-expandable aortic transcatheter valves (THVs) from September 2012 to March 2017. Pulmonary artery systolic blood pressure (PASP) by echocardiogram was available in 90 patients. The subjects were stratified based on PASP: No PH = PASP ≤35 mmHg (n = 11); mild to moderate PH = PASP 36-49 mmHg (n = 21) and severe PH = PASP ≥50 mmHg (n = 58). Clinical, procedural, and echocardiographic outcomes were assessed., Results: Mean age was 72.7 (±12.8) years, 59 (65.6%) were female, Society of Thoracic Surgeons score was 15.8 + 11.8% and 90.0% where in New York Heart Association (NYHA) class III-IV. There was no significant difference in all-cause mortality at 30 days (no PH = 27.3%, mild-moderate PH = 19.0%, severe PH = 31.6%; p = 0.55) or at 1 year (no PH = 54.5%, mild-moderate PH = 38.1%, severe PH = 56.1%; p = 0.36). No difference in adverse events, NYHA class or amount of residual mitral regurgitation at 1 year were observed between the groups., Conclusion: This study suggests that the presence of PH in patients with predominantly mitral stenosis with MAC undergoing TMVR does not impact mortality or adverse events. Further studies are needed to fully understand the effect of PH in this group of patients., (© 2022 Wiley Periodicals LLC.)

Background: Patients presenting with acute myocardial infarction complicated by cardiogenic shock (AMI-CS) are at high risk for impaired antiplatelet activity secondary to malabsorption, systemic hypoperfusion, hypothermia, need for mechanical ventilation, and high use of analgesics. The use of antiplatelet therapy in these high-risk patients is not well studied., Methods: Using the National Cardiogenic Shock Initiative database, we analyzed patients who presented with AMI-CS at 60 hospitals from March 2018 to December 2020. All patients were treated using a standard shock protocol. Herein, the patterns of antiplatelet use are described., Results: A total of 204 patients were included in the analysis, of which 174 (85.3%) presented with ST-segment elevation myocardial infarction (STEMI). The majority (84.3%) received antiplatelet therapy before percutaneous coronary intervention (PCI); of those who received antiplatelets, 77.9% received aspirin, 55.2% received an oral P2Y12 inhibitor, and 19.2% received intravenous (IV) antiplatelet therapy. Ticagrelor was the most common P2Y12 inhibitor administered (41.9%), followed by clopidogrel (12.2%) and prasugrel (1.2%). Only 18.6% of oral antiplatelet agents were crushed. Baseline characteristics of patients who received IV vs non-IV antiplatelet agents were similar. Thrombolysis in Myocardial Infarction (TIMI) 0 flow was present in 69.6% of patients before PCI and aspiration thrombectomy was performed in 24.5% of patients. The presence of STEMI, cardiac arrest, cardiopulmonary resuscitation, hypothermia, vasopressor use, elevated lactate levels, or number of vessels treated did not influence the use of IV antiplatelet agents., Conclusions: The use of crushed and IV antiplatelet agents in AMI-CS is low. Further studies are needed in this high-risk population to assess whether more potent antiplatelet inhibition will improve outcomes.

Cardiogenic shock (CS) is associated with significant morbidity and mortality. Differentiating the etiologic factors driving CS has epidemiological significance and aids in optimization of therapeutic strategies, prognostication, and resource utilization. The aim herein is to investigate the epidemiology and clinical outcomes of CS in those with ischemic and nonischemic CS etiologies. Using International Classification of Diseases codes, we queried the national inpatient sample for CS hospitalization from 2007 to 2018 and divided the study sample into cohorts of ischemic (I-CS) and nonischemic cardiogenic shock (NI-CS). We then compared the primary outcome of in-hospital mortality between these 2 cohorts. Two groups of secondary outcomes (clinical and procedural) were also assessed between the 2 cohorts. CS was present in 557,860 hospitalizations; 84% of these were I-CS and 15.8% NI-CS. Patients with I-CS were older, more commonly males, with more risk factors for coronary artery disease (P < 0.05). NI-CS had higher prevalence of preexisting systolic heart failure and atrial fibrillation. The in-hospital mortality was significantly higher in patients with I-CS (32.2% vs. 29.5%, adjusted odds ratio 1.10, P < 0.001). Frequencies of acute ischemic stroke, mechanical ventilation, ventricular arrhythmias, and vascular complications were higher in I-CS versus NI-CS, while acute kidney injury and acute liver failure were more common in NI-CS (P < 0.05). The use of mechanical circulatory support devices was higher in the I-CS group. In conclusion, patients with I-CS comprise the vast majority of CS and are associated with higher mortality and higher resource utilization. Conversely, patients with NI-CS appear to have higher survival but with a higher prevalence of end-organ dysfunction., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: This study sought to evaluate the differences in cardiogenic shock patient characteristics in trial patients and real-life patients., Background: Cardiogenic shock (CS) is a leading cause of mortality in patients presenting with acute myocardial infarction (AMI). However, the enrollment of patients into clinical trials is challenging and may not be representative of real-world patients., Methods: We performed a systematic review of studies in patients presenting with AMI-related CS and compared patient characteristics of those enrolled into randomized controlled trials (RCTs) with those in registries., Results: We included 14 RCTs (n = 2,154) and 12 registries (n = 133,617). RCTs included more men (73% vs 67.7%, P < 0.001) compared with registries. Patients enrolled in RCTs had fewer comorbidities, including less hypertension (61.6% vs 65.9%, P < 0.001), dyslipidemia (36.4% vs 53.6%, P < 0.001), a history of stroke or transient ischemic attack (7.1% vs 10.7%, P < 0.001), and prior coronary artery bypass graft surgery (5.4% vs 7.5%, P < 0.001). Patients enrolled in RCTs also had lower lactate levels (4.7 ± 2.3 mmol/L vs 5.9 ± 1.9 mmol/L, P < 0.001) and higher mean arterial pressure (73.0 ± 8.8 mm Hg vs 62.5 ± 12.2 mm Hg, P < 0.001). Percutaneous coronary intervention (97.5% vs 58.4%, P < 0.001) and extracorporeal membrane oxygenation (11.6% vs 3.4%, P < 0.001) were used more often in RCTs. The in-hospital mortality (23.9% vs 38.4%, P < 0.001) and 30-day mortality (39.9% vs 45.9%, P < 0.001) were lower in RCT patients., Conclusions: RCTs in AMI-related CS tend to enroll fewer women and lower-risk patients compared with registries. Patients enrolled in RCTs are more likely to receive aggressive treatment with percutaneous coronary intervention and extracorporeal membrane oxygenation and have lower in-hospital and 30-day mortality., Competing Interests: Funding Support and Author Disclosures Dr Basir is a consultant/speaker for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll. Dr Alaswad has received honoraria for consulting/speaking from Boston Scientific, Cardiovascular Systems Inc, LivaNova, and Teleflex. Dr Brilakis has received honoraria for consulting/speaking from Abbott Vascular, American Heart Association (associate editor Circulation), Amgen, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, Cardiovascular Systems Inc, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; has received research support from Regeneron and Siemens; and is a shareholder of MHI Ventures. Dr Napp has received honoraria for lecturing/consulting and has received research support from Cytosorbents; has received honoraria for lecturing from Abbott and Maquet; and has received honoraria for lecturing/proctoring/consulting and research funding from Abiomed. Dr O’Neill is a consultant/speaker for Abbott Vascular, Abiomed, Boston Scientific, Edwards, and Zoll. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Human papillomavirus-associated head and neck squamous cell carcinoma (HPV+ HNSCC) is recognized as a distinct disease with unique etiology and clinical features. Current standard of care therapeutic modalities are identical for HPV+ and HPV- HNSCC and thus, there remains an opportunity to develop innovative pharmacologic approaches to exploit the inherent vulnerabilities of HPV+ HNSCC. In this study, using an inducible HPVE6E7 knockdown system, we found that HPV+ HNSCC cells are addicted to HPVE6E7, such that loss of these viral oncogenes impaired tumorigenicity in vitro and in vivo. A number of druggable pathways, including PPAR and Wnt, were modulated in response to HPVE6E7 loss. Fenofibrate showed significant anti-proliferative effects in a panel of HPV+ cancer cell lines. Additionally, fenofibrate impaired tumor growth as monotherapy and potentiated the activity of cisplatin in a pre-clinical HPV+ animal model. Systemic fenofibrate treatment induced p53 protein accumulation, and surprisingly, re-programmed the tumor-immune microenvironment to drive immune cell infiltration. Since fenofibrate is FDA-approved with a favorable long-term safety record, repositioning of this drug, as a single agent or in combination with cisplatin or checkpoint blockade, for the HPV+ HNSCC setting should be prioritized.

Background: Due to elevated surgical risk, transcatheter mitral valve replacement (TMVR) is used as an alternative for treating failed bioprosthetic valves, annuloplasty repairs and mitral annular calcification (MAC). We report the procedural and longitudinal outcomes for each subtype: Mitral valve-in-valve (MVIV), mitral valve-in-ring (MViR), and valve-in-MAC (ViMAC)., Methods: Consecutive patients undergoing TMVR from October 2013 to December 2019 were assessed. Patients at high risk for left ventricular outflow tract obstruction had either alcohol septal ablation or intentional laceration of the anterior leaflet (LAMPOON)., Results: Eight-eight patients underwent TMVR; 38 MViV, 31 MViR, and 19 ViMAC procedures were performed. The median Society of Thoracic Surgery 30-day predicted risk of mortality was 8.2% (IQR 5.2, 19.9) for all. Sapien 3 (78%) and transseptal access (98%) were utilized in most cases. All-cause in-hospital mortality, technical, and procedural success were 8%, 83%, and 66% respectively. Median follow up was 1.4 years (IQR 0.5-2.9 years) and overall survival was 40% at 4 years. Differential survival rates were observed with MViV doing the best, followed by MViR and ViMAC having a <20% survival at 4 years. After adjusting for co-variates, MViV procedure was the strongest predictor of survival (HR 0.24 [95% CI 0.079-0.7])., Conclusion: TMVR is performed in at high-risk patients with attenuated long-term survival. MViV has the best success and survival rate, but long-term survival in MViR and ViMAC is guarded., (© 2021 Wiley Periodicals LLC.)

Laser machining of glassy carbon was experimentally investigated using a 1065 nm wavelength Yb-based master oscillator power amplifier fiber laser source. Ablation characteristics were determined for SIGRADUR G glassy carbon samples using laser fluence of less than 3 J / c m 2 . The ablation threshold was found to be 0.31 J / c m 2 for incident pulse repetition rates of 250 and 500 kHz. Glassy carbon exhibited excellent machining characteristics with features of clearly defined edges and smooth surfaces. The ablation rate varied linearly with fluence over the range 0.31-1.3 J / c m 2 . High-quality glassy carbon microstructures were created with optimum laser parameters.

[Figure: see text].

Purpose: Measurements of breast arterial calcifications (BAC) can offer a personalized, non-invasive approach to risk-stratify women for cardiovascular diseases such as heart attack and stroke. We aim to detect and segment breast arterial calcifications in mammograms accurately and suggest novel measurements to quantify detected BAC for future clinical applications., Methods: To separate BAC in mammograms, we propose a lightweight fine vessel segmentation method Simple Context U-Net (SCU-Net). Due to the large image size of mammograms, we adopt a patch-based way to train SCU-Net and obtain the final whole-image-size results by stitching patchwise results together. To further quantify calcifications, we test five quantitative metrics to inspect the progression of BAC for subjects: sum of mask probability metric ( P M ), sum of mask area metric ( A M ), sum of mask intensity metric ( S I M ), sum of mask area with threshold intensity metric T A M X , and sum of mask intensity with threshold X metric T S I M X . Finally, we demonstrate the ability of the metrics to longitudinally measure calcifications in a group of 26 subjects and evaluate our quantification metrics compared with calcified voxels and calcium mass on breast CT for 10 subjects., Results: Our segmentation results are compared with state-of-the-art network architectures based on recall, precision, accuracy, F1 score/Dice score, and Jaccard index evaluation metrics and achieve corresponding values of 0.789, 0.708, 0.997, 0.729, and 0.581 for whole-image-size results. The quantification results all show >95% correlation between quantification measures on predicted masks of SCU-Net as compared to the groundtruth and measurement of calcification on breast CT. For the calcification quantification measurement, our calcification volume (voxels) results yield R 2 -correlation values of 0.834, 0.843, 0.832, 0.798, and 0.800 for the P M , A M , S I M , T A M 100 , T S I M 100 metrics, respectively; our calcium mass results yield comparable R 2 -correlation values of 0.866, 0.873, 0.840, 0.774, and 0.798 for the same metrics., Conclusions: Simple Context U-Net is a simple method to accurately segment arterial calcification retrospectively on routine mammograms. Quantification of the calcifications based on this segmentation in the retrospective cohort study has sufficient sensitivity to detect the normal progression over time and should be useful for future research and clinical applications., (© 2021 American Association of Physicists in Medicine.)

Cardiogenic shock (CS) is a condition associated with high mortality rates in which prognostication is uncertain for a variety of reasons, including its myriad causes, its rapidly evolving clinical course and the plethora of established and emerging therapies for the condition. A number of validated risk scores are available for CS prognostication; however, many of these are tedious to use, are designed for application in a variety of populations and fail to incorporate contemporary hemodynamic parameters and contemporary mechanical circulatory support interventions that can affect outcomes. It is important to separate patients with CS who may recover with conservative pharmacological therapies from those in who may require advanced therapies to survive; it is equally important to identify quickly those who will succumb despite any therapy. An ideal risk-prediction model would balance incorporation of key hemodynamic parameters while still allowing dynamic use in multiple scenarios, from aiding with early decision making to device weaning. Herein, we discuss currently available CS risk scores, perform a detailed analysis of the variables in each of these scores that are most predictive of CS outcomes and explore a framework for the development of novel risk scores that consider emerging therapies and paradigms for this challenging clinical entity., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Percutaneous ventricular assist devices (pVAD) are frequently utilized in high-risk percutaneous coronary intervention (HR-PCI) to provide hemodynamic support in patients with complex cardiovascular disease and/or multiple comorbidities who are poor candidates for surgical revascularization. Using the National Inpatient Sample we identified pVAD-assisted PCI (excluding intra-aortic balloon pump) in patients without cardiogenic shock from January 2008 to December 2018. We evaluated the trends in patient and procedural characteristics, and complication rates across the 11-year study period. A total of 26,661 pVAD-PCI was performed. From 2008 to 2018 there has was a 27-fold increase in the number of pVAD-PCIs performed annually. There has also been an increase in the proportion of procedures performed in small to medium sized hospitals. The use of atherectomy, image-guided PCI, FFR/iFR, drug-eluting stents, and multi-vessel intervention has significantly increased. Patients undergoing pVAD-PCI had a higher burden of comorbidities, without a significant difference in mortality over time. There were decreased rates of acute stroke and blood transfusions over time, while vascular complications and acute kidney injury (AKI) requiring dialysis remained mostly unchanged. In conclusion, the use of pVAD for HR-PCI has increased significantly, along with adjunctive PCI techniques such as atherectomy, intravascular imaging, and physiologic lesion assessment. With increasing use of this device, there appeared to be lower rates of peri-procedural stroke, and blood transfusions. Despite a higher burden of comorbidities, adjusted mortality remained stable over time., (Copyright © 2021 Elsevier Inc. All rights reserved.)

In head and neck squamous cell carcinoma (HNSCC), anti-PD-1 inhibitors are approved for recurrent/metastatic (R/M) disease and anticipated to expand to other indications. The impact of p16 status and anatomical site on overall survival (OS) in immunotherapy-treated HNSCC patients remains unresolved. We performed a retrospective analysis of R/M HNSCC patients receiving anti-PD-1 immunotherapy at our academic medical center with an extensive community satellite network. Fifty-three R/M HNSCC patients were treated with anti-PD-1 immunotherapy and had a median OS of 6 months. Anatomical site was associated with distinct OS; oropharynx and larynx patients have superior OS compared to oral cavity patients. Analysis of the OPSCC subset showed p16+ status as a favorable, independent prognostic biomarker (HR 7.67 (1.23-47.8); p = 0.029). Further studies to assess the link between anatomical site, p16 status, and anti-PD-1 treatment outcomes in large cohorts of R/M HNSCC patients managed in real-world clinical practices and clinical trials should be prioritized.

Background: Acute myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high mortality. Patients ≥75 years old represent an increasing proportion of those who present with AMICS and are at high risk for adverse outcomes., Methods: The National Cardiogenic Shock Initiative includes patients with AMICS treated using a standard shock protocol with early invasive hemodynamic monitoring, mechanical circulatory support (MCS), and percutaneous coronary intervention (PCI). We evaluated the outcomes of patients based on their age group, dividing them into <75 and ≥75 years old., Results: We included 300 consecutive patients: 238 were <75 years old (79.3%) and 62 patients ≥75 years old. There were significant differences in survival; patients <75 years old had a 75.6% survival, while those ≥75 years old had a 50% survival (adjusted OR: 10.4, P = 0.001). SCAI shock classification impacted survival as well; those <75 years old with class C or D shock had a survival of 84%, compared with 57% in those ≥75 years old. Patients ≥75 years old requiring 1 or 2 vasopressors had significantly lower survival rates (36% and 25%, respectively) when compared with patients <75 years old (76.7% with 1 and 60.5% with >1 vasopressor)., Conclusions: Age is inversely proportional to survival; patients <75 years old have high rates of survival if treated using best practices with invasive hemodynamic monitoring, early MCS, and PCI. However, using a standardized protocol can improve survival in the elderly; therefore, age on its own should not be a reason to withhold PCI or MCS use., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Transcaval transcatheter aortic valve replacement (TC-TAVR) is an alternative approach to transcatheter aortic valve replacement involving deployment of the bioprosthetic valve via a conduit created from the inferior vena cava to the descending aorta in patients for whom the traditional transfemoral approach is not feasible. By analyzing the largest known cohort of TC-TAVR patients, the authors wished to compare hospital length of stay and post-procedure outcomes between patients who underwent the procedure under deep sedation (DS) and patients who underwent general anesthesia with an endotracheal tube., Design: Retrospective, single-center study., Setting: Henry Ford Hospital in Detroit, MI., Participants: Patients undergoing TC-TAVR from 2015 to 2018., Measurements and Main Results: Seventy-nine patients were included in the analysis, which consisted of 38 under general anesthesia with an endotracheal tube and 41 under DS. The sample was divided into a general anesthesia (GA) group and DS group. There were no significant differences in implant success rate or post-procedure outcomes, including in-hospital mortality (p = 0.999) and major vascular complication rate (p = 0.481), between the two groups. Patients in the GA group stayed a median of 24 hours longer in the intensive care unit (ICU) (p < 0.001) and one day longer in the hospital (p = 0.046) after the procedure compared to patients in the DS group. The median procedure time was significantly lower (135 minutes) in the DS group compared to the GA group (167 minutes, p < 0.001)., Conclusions: Patients undergoing TC-TAVR under DS had similar postoperative outcomes and shorter post-procedure hospital and ICU lengths of stay compared to general anesthesia. In the authors' experience, DS is the preferred anesthetic technique for TC-TAVR., (Copyright © 2020 Elsevier Inc. All rights reserved.)

A plethora of catheter-based strategies have been developed to treat mitral valve disease. Evolving 3-dimensional (3D) multidetector computed tomography (MDCT) technology can accurately reconstruct the mitral valve by means of 3-dimensional computational modeling (3DCM) to allow virtual implantation of catheter-based devices. 3D printing complements computational modeling and offers implanting physician teams the opportunity to evaluate devices in life-size replicas of patient-specific cardiac anatomy. MDCT-derived 3D computational and 3D-printed modeling provides unprecedented insights to facilitate hands-on procedural planning, device training, and retrospective procedural evaluation. This overview summarizes current concepts and provides insight into the application of MDCT-derived 3DCM and 3D printing for the planning of transcatheter mitral valve replacement and closure of paravalvular leaks. Additionally, future directions in the development of 3DCM will be discussed., Competing Interests: Funding Support and Author Disclosures Dr. Wang has served as a consultant for Edwards Lifesciences, Boston Scientific, and Materialise. Dr. Redwood has served as a proctor and consultant for Edwards Lifesciences. Dr. Popma has received institutional grants from Medtronic, Boston Scientific, Edwards Lifesciences, and Abbott; and is a member of the Medical Advisory Board of Edwards Lifesciences. Dr. Little has served as a consultant for Abbot Cardiovascular and Medtronic; and has received a research grant from Siemens Health. Dr. Pfeiffer has served as a consultant for LivaNova Inc.; and has served as a speaker and proctor for Edwards Lifesciences and Abbott Cardiovascular. Dr. Dahle has served as a proctor for Abbot Cardiovascular. Mrs. Minet is a former employee of Materialise NV. Dr. O’Neill has served as a consultant for Boston Scientific. Dr. Van Mieghem has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has served as a consultant for Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Pie Medical, and Materialise NV. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To compare clinical features and outcomes in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) treated in the early experience with Impella percutaneous ventricular assist device and patients treated recently., Background: Since pre-market approval (PMA) of Impella device as treatment for AMICS, use of the device has grown considerably., Methods: We retrospectively analyzed 649 AMICS patients treated with perioperative Impella, with 291 patients treated from 2008 to 2014 comprising the early experience cohort and 358 patients treated from 2017 to 2019 comprising the recent experience cohort. The primary end point was risk adjusted in-hospital mortality., Results: Mean age and gender distribution of patients was similar in the two cohorts. The recent cohort had more invasive hemodynamic monitoring (64% vs 46%; P < .001) and less use of an intra-aortic balloon pump prior to Impella (15% vs 41%; P < .001). Recently treated patients were significantly more likely to receive Impella support prior to PCI (58% vs 44%; P = .005). In-hospital mortality was lower in the recent cohort (48% vs 56%; P = .043). This difference was however no longer significant after risk adjustment (adjusted OR 0.89, 95% CI 0.59-1.34, P = .59). Rates of acute kidney injury, major bleeding, and vascular complications requiring surgery were also significantly lower in the recent cohort., Conclusions: Use of Impella for AMICS during recent years is associated with lower unadjusted in-hospital mortality, which may reflect better patient selection, earlier device implantation, and improved management algorithms. In-depth understanding of these factors may inform the development of future treatment protocols., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Device-related thrombus (DRT) has been considered an Achilles' heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited., Objectives: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT., Methods: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT., Results: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors., Conclusions: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO., Competing Interests: Funding Support and Author Disclosures Dr Maarse has received an unrestricted grant from Boston Scientific. Dr Pérez de Prado has served as a proctor for Boston Scientific. Dr Gupta has served as a proctor for Abbott. Dr Sanchez has served as a speaker and proctor for Boston Scientific. Dr Demkow has served as a proctor for Abbott and Boston Scientific. Dr Alkhouli has served as a consultant for Boston Scientific. Dr Wang has been a consultant for Edwards LifeSciences, Boston Scientific, and Neochord; and has received research grant support from Boston Scientific assigned to employer Henry Ford health system. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background Cardiogenic shock (CS) is a heterogeneous syndrome with varied presentations and outcomes. We used a machine learning approach to test the hypothesis that patients with CS have distinct phenotypes at presentation, which are associated with unique clinical profiles and in-hospital mortality. Methods and Results We analyzed data from 1959 patients with CS from 2 international cohorts: CSWG (Cardiogenic Shock Working Group Registry) (myocardial infarction [CSWG-MI; n=410] and acute-on-chronic heart failure [CSWG-HF; n=480]) and the DRR (Danish Retroshock MI Registry) (n=1069). Clusters of patients with CS were identified in CSWG-MI using the consensus k means algorithm and subsequently validated in CSWG-HF and DRR. Patients in each phenotype were further categorized by their Society of Cardiovascular Angiography and Interventions staging. The machine learning algorithms revealed 3 distinct clusters in CS: "non-congested (I)", "cardiorenal (II)," and "cardiometabolic (III)" shock. Among the 3 cohorts (CSWG-MI versus DDR versus CSWG-HF), in-hospital mortality was 21% versus 28% versus 10%, 45% versus 40% versus 32%, and 55% versus 56% versus 52% for clusters I, II, and III, respectively. The "cardiometabolic shock" cluster had the highest risk of developing stage D or E shock as well as in-hospital mortality among the phenotypes, regardless of cause. Despite baseline differences, each cluster showed reproducible demographic, metabolic, and hemodynamic profiles across the 3 cohorts. Conclusions Using machine learning, we identified and validated 3 distinct CS phenotypes, with specific and reproducible associations with mortality. These phenotypes may allow for targeted patient enrollment in clinical trials and foster development of tailored treatment strategies in subsets of patients with CS.

A 65-year-old female was transferred with myocardial infarction, three-vessel coronary artery disease, cardiogenic shock and an intraaortic balloon pump. Given persistent shock, mechanical circulatory support (MCS) was upgraded using a left ventricular hemodynamic support device (Impella CP). The patient was monitored in the catheterization laboratory and serial hemodynamic measures were obtained. Initial hemodynamics showed relative improvement; however, serial assessments demonstrated worsening hemodynamics secondary to right ventricular failure, ultimately requiring a right ventricular hemodynamic support device. The case highlights the rapid changes that can occur with mechanical circulatory support devices and demonstrates the importance of obtaining serial hemodynamics in the cardiac catheterization laboratory., (© 2021 Wiley Periodicals LLC.)

Purpose: Human papilloma virus-positive (HPV+) oropharyngeal squamous cell carcinoma (OPSCC), diagnosed with p16 immunohistochemistry, is associated with favorable prognosis; however, this connection was established using European American (EA)-skewed populations. The impact of p16/human papillomavirus status on outcomes in African American (AA) OPSCC patients remains to be settled. In this study, we determine the association between cancer disparity and p16 status in an OPSCC cohort controlling for time to treatment initiation (TTI), a surrogate for medical care access., Materials and Methods: We analyzed data from all patients diagnosed with OPSCC (N = 440) between 2010 and 2017, who received treatment at our academic medical center. Associations between age, disease stage, sex, p16 status, race, TTI, and overall survival (OS) were investigated., Results: TTI was similar between AA and EA OPSCC patients in our p16+ ( P = .291) or p16- ( P = .715) cohorts. Among p16+ OPSCC patients, the median OS was > 8.65 years for EA patients compared with 5.038 years (95% CI, 2.019 to 5.30; P = .003, log-rank) for AA patients. For p16- patients, the median OS was 5.74 years (95% CI, 3.32 to 6.99) for EA patients and 1.85 years (95% CI, 0.978 to 4.50; P = .03, log-rank) for AA patients. Multivariate Cox regression analysis showed that race was an independent prognostic biomarker and the most impactful co-variate for OS (hazard ratio, 0.40; 95% CI, 0.00 to 0.69; P = .001)., Conclusion: Our work showed that AAs with p16+ OPSCC have surprisingly poor clinical outcomes and are thus poor candidates for treatment de-escalation regimens. Caution should be exercised when extending clinical guidelines based on EA-majority studies to non-EA populations., Competing Interests: Rod RezaeeHonoraria: Zimmer BiometSpeakers' Bureau: Zimmer BiometPatents, Royalties, Other Intellectual Property: Zimmer/Biomet trauma fixation deviceTravel, Accommodations, Expenses: Zimmer BioMet Quintin PanResearch Funding: Bristol Myers Squibb FoundationPatents, Royalties, Other Intellectual Property: I have patents on p53 reactivation therapeutics for HPV+ HNSCCNo other potential conflicts of interest were reported.

Objectives: The aim of this study was to evaluate the combined impact of race, ethnicity, and sex on in-hospital outcomes using data from the National Inpatient Sample., Background: Cardiogenic shock (CS) is a major cause of mortality following ST-segment elevation myocardial infarction (STEMI). Early revascularization reduces mortality in such patients. Mechanical circulatory support (MCS) devices are increasingly used to hemodynamically support patients during revascularization. Little is known about racial, ethnic, and sex disparities in patients with STEMI and CS., Methods: The National Inpatient Sample was queried from January 2006 to September 2015 for hospitalizations with STEMI and CS. The associations between sex, race, ethnicity, and outcomes were examined using complex-samples multivariate logistic or generalized linear model regressions., Results: Of 159,339 patients with STEMI and CS, 57,839 (36.3%) were women. In-hospital mortality was higher for all women (range 40% to 45.4%) compared with men (range 30.4% to 34.7%). Women (adjusted odds ratio [aOR]: 1.11; 95% confidence interval [CI]: 1.06 to 1.16; p < 0.001) as well as Black (aOR: 1.18; 95% CI: 1.04 to 1.34; p = 0.011) and Hispanic (aOR: 1.19; 95% CI: 1.06 to 1.33; p = 0.003) men had higher odds of in-hospital mortality compared with White men, with Hispanic women having the highest odds of in-hospital mortality (aOR: 1.46; 95% CI: 1.26 to 1.70; p < 0.001). Women were older (age: 69.8 years vs. 63.2 years), had more comorbidities, and underwent fewer invasive cardiac procedures, including revascularization, right heart catheterization, and MCS., Conclusions: There are significant racial, ethnic, and sex differences in procedural utilization and clinical outcomes in patients with STEMI and CS. Women are less likely to undergo invasive cardiac procedures, including revascularization and MCS. Women as well as Black and Hispanic patients have a higher likelihood of death compared with White men., Competing Interests: FUNDING SUPPORT AND Author Disclosures Dr. Basir is a consultant for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll. Dr. O’Neill is a consultant for Abiomed, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)