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BackgroundThe LATERAL trial validated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare HVAD System, leading to Food and Drug Administration approval. We sought to analyze 24-month adverse event (AE) rates, including a temporal analysis of the risk profile, associated with the thoracotomy approach for the HVAD system.MethodsAEs from the LATERAL trial were evaluated over 2 years postimplant. Data was obtained from the Interagency Registry for Mechanically Assisted Circulatory Support database for 144 enrolled United States and Canadian patients. Temporal AE profiles were expressed as events per patient year.ResultsDuring 162.5 patient years of support, there were 25 driveline infections (0.15 events per patient year), 50 gastrointestinal bleeds (0.31 events per patient year), and 21 strokes (0.13 events per patient year). Longitudinal AE analysis at follow-up intervals of

Background: Data on out‐of‐ice implantation ischemia in heart transplant are scarce. We examined implantation time's impact on allograft dysfunction. Methods: We conducted a single‐site retrospective review of all primary adult heart transplants from June 2012 to August 2019 for implantation warm ischemic time (WIT), defined as first atrial stitch to aortic crossclamp removal. Univariate regression was used to assess the relationship of perioperative variables to primary graft dysfunction (PGD) and to pulmonary artery pulsatility index (PAPi) at postoperative hour 24. A threshold of p <.10 was set for the inclusion of covariates in multivariate regression. Secondary analyses evaluated for consistency among alternative criteria for allograft dysfunction. A post hoc subgroup analysis examined WIT effect in prolonged total ischemia of 240 min or longer. Results: Complete data were available for 201 patients. Baseline characteristics were similar between patients who did and did not have WIT documented. In univariate analysis, female gender, longer total ischemic time (TIT), longer bypass time, greater blood transfusions, and pretransplant intensive care unit (ICU) care were associated with PGD, whereas longer bypass time was associated with worse PAPi and pretransplant ICU care was associated with better PAPi. In multivariate analysis, longer bypass time predicted PGD, and worse PAPi and preoperative ICU admission predicted PGD and better PAPi. Results did not differ in secondary or subgroup analyses. Conclusions: This study is one of few examining the functional impact of cardiac implantation ischemia. Results suggest allograft implantation time alone may not impact postoperative graft function, which was driven by intraoperative bypass duration and by preoperative ICU care, instead. [ABSTRACT FROM AUTHOR]

The article presents a case study of a 26-year-old woman who developed confusion and lethargy after unwitnessed inhaling of suspected 1,2-difluoroethane in an aerosol. It discusses the results of an attempt to treat a patient acutely intoxicated with inhaled 1,2-difluoroethane by administering substances that compensate for disrupted cellular metabolism.

Background: The management of the recall is complicated by the competing risks of lead failure and complications that can occur with lead revision. Many of these patients are currently undergoing an elective generator change—an ideal time to consider lead revision. Objective: To determine the cost-effectiveness of a proactive management strategy for the Sprint Fidelis recall. Methods: We obtained detailed clinical outcomes and costing data from a retrospective analysis of 341 patients who received the Sprint Fidelis lead in British Columbia, where patients younger than 60 years were offered lead extraction when undergoing generator replacement. These population-based data were used to construct and populate a probabilistic Markov model in which a proactive management strategy was compared to a conservative strategy to determine the incremental cost per lead failure avoided. Results: In our population, elective lead revisions were half the cost of emergent revisions and had a lower complication rate. In the model, the incremental cost-effectiveness ratio of proactive lead revision versus a recommended monitoring strategy was $12,779 per lead failure avoided. The proactive strategy resulted in 21 fewer failures per 100 patients treated and reduced the chance of an additional complication from an unexpected surgery. Conclusions: Cost-effectiveness analysis suggests that prospective lead revision should be considered when patients with a Sprint Fidelis lead present for pulse generator change. Elective revision of the lead is justified even when 25% of the population is operated on per year, and in some scenarios, it is both less costly and provides a better outcome. [Copyright &y& Elsevier]

Supplemental Digital Content is available in the text. Background: There has been increasing use of extracorporeal membrane oxygenation (ECMO) as bridge to heart transplant (orthotopic heart transplant [OHT]) or left ventricular assist device (LVAD) over the last decade. We aimed to provide insights on the population, outcomes, and predictors for the selection of each therapy. Methods: Using the Extracorporeal Life Support Organization Registry between 2010 and 2019, we compared in-hospital mortality and length of stay, predictors of OHT versus LVAD, and predictors of in-hospital mortality for patients with cardiogenic shock that were bridged with ECMO to OHT or LVAD. One hundred sixty-seven patients underwent LVAD versus 234 patients who underwent OHT. Results: The overall use of ECMO has increased from 1.7% in 2010 to 22.2% in 2019. Mortality was similar between groups (LVAD: 28.7% versus OHT: 29.1%) while length of stay was longer for OHT (LVAD: 49.6 versus OHT: 59.5 days, P =0.05). Factors associated with OHT included prior transplant (odds ratio [OR]=31.26 [CI, 3.84–780.5]), use of a temporary pacemaker (OR=6.5 [CI, 1.39–50.15]), and increased use of inotropes on ECMO (OR=3.77 [CI, 1.39–11.07]), whereas LVAD use was associated with weight (OR=0.98 [CI, 0.97–0.99]), cardiogenic shock presentation (OR=0.40 [CI, 0.21–0.78]), previous LVAD (OR=0.01 [CI, 0.0001–0.22]), respiratory failure (OR=0.28 [CI, 0.11–0.70]), and milrinone infusion (OR=0.32 [CI, 0.15–0.67]). Older age (OR=1.07 [CI, 1.02–1.12]), cannulation bleeding (OR=26.1 [CI, 4.32–221.3]), and surgical bleeding (OR=6.7 [CI, 1.26–39.9]) in patients receiving LVAD and respiratory failure (OR=5 [CI, 1.17–23.1]) and continuous renal replacement therapy (OR=3.82 [CI, 1.28–11.9]) in patients receiving OHT were associated with increased mortality. Conclusions: ECMO use as a bridge to advanced therapies has increased over time, with more patients undergoing LVAD than OHT. Mortality was equal between the 2 groups while length of stay was longer for OHT. [ABSTRACT FROM AUTHOR]

Superior vena cava (SVC) syndrome, characterized by swelling of the upper torso, can result from a wide range of causes. The presence and severity of clinical symptoms depends on the degree of stenosis, the location of stenosis, the speed of development of stenosis, and existing collateral flow. Acute complete occlusion of the SVC frequently leads to poor neurologic outcomes such as coma or death. We report a case of a patient who had complete neurologic recovery after 26 minutes of acute total occlusion of the SVC. This report highlights the importance of meticulous management during acute SVC occlusion to improve patient outcome. [ABSTRACT FROM AUTHOR]

We present a patient with a right ventricular hemangioma and symptomatic right ventricular outflow tract obstruction. [ABSTRACT FROM AUTHOR]

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Introduction: Traumatic cardiac injury (TCI) poses a significant risk of morbidity and mortality, yet there is a lack of population-based outcomes data for these patients., Methods: The authors examined national yearly trends, demographics, and in-hospital outcomes of TCI using the National Inpatient Sample from 2007 to 2014. We focused on adult patients with a primary discharge diagnosis of TCI, categorizing them into blunt (BTCI) and penetrating (PTCI) cardiac injury., Results: A total of 11,510 cases of TCI were identified, with 7,155 (62.2%) classified as BTCI and 4,355 (37.8%) as PTCI. BTCI was predominantly caused by motor vehicle collisions (66.7%), while PTCI was mostly caused by piercing injuries (67.4%). The overall mortality rate was 11.3%, significantly higher in PTCI compared to BTCI (20.3% vs. 5.9%, χ 2 (1, N = 11,185) = 94.9, p <0.001). Additionally, 21.5% required blood transfusion, 19.6% developed hemopericardium, and 15.9% suffered from respiratory failure. Procedures such as heart and pericardial repair were more common in PTCI patients. Length of hospitalization and cost of care were also significantly higher for PTCI patients, W(1, N = 11,015) = 88.9, p <0.001)., Conclusions: Patients with PTCI experienced higher mortality rates than those with BTCI. Within the PTCI group, young men from minority racial groups and low-income households had poorer outcomes. This highlights the need for early and specialized attention from emergency and cardiothoracic providers for patients in these demographic groups., (Copyright © 2024 Mehta, et al.)

Importance: Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety., Objective: To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding., Design, Setting, and Participants: This international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months., Intervention: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen., Main Outcomes and Measures: The composite primary end point, assessed for noninferiority (-10% margin) of placebo, was survival free of a major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events., Results: Of the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) vs those taking aspirin (68%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, -1.6%]; P < .001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; P = .002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics., Conclusions and Relevance: In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events., Trial Registration: ClinicalTrials.gov Identifier: NCT04069156.

Background: There is a paucity of data on readmission rates and predictors of readmissions in cardiogenic shock patients after contemporary Extracorporeal Membrane Oxygenation (ECMO) use., Methods: Using the Nationwide Readmission Database, we included adult patients (≥18 years old) hospitalized between January to November 2016-2018 for cardiogenic shock requiring ECMO support. Thirty-day readmission rates, associated variables, and predictors of readmission were assessed., Results: A total of 10,723 patients underwent ECMO for cardiogenic shock. After excluding patients who died ( n  = 5602; 52%) and who underwent LVAD or OHT during index admission ( n  = 892; 8%), 4229 patients discharged alive were included. Of those, 694 (16.4%) were readmitted within 30 days. The median time to readmission was 10 days. Diabetes mellitus (OR = 1.77; 95% CI 1.32-2.37), chronic liver disease (OR = 1.35; 95% CI 1.03-1.77), and prolonged LOS (≥30 days; OR = 1.38; 95% CI 1.05-1.81) were associated with increased risk of 30-day readmissions while heart failure diagnosis (OR = 0.69; 95% CI 0.50-0.95) and short-term hospital post-discharge care (OR = 0.53; 95% CI 0.28-0.99) conferred a lower risk. Sepsis, followed by congestive heart failure, was the most common readmission diagnoses., Conclusions: Patients with CS requiring ECMO support have high mortality and high 30-day readmission rates, with sepsis being the leading cause of readmissions followed by heart failure., Competing Interests: Joseph E. Tonna, MD reports a relationship with LivaNova and Philips Healthcare that includes: speaking and lecture fees and travel reimbursement. Joseph E. Tonna, MD reports a relationship with The National Institutes of Health, The National Heart, Lung, And Blood Institute that includes: funding grants., (© 2021 Published by Elsevier Inc.)

Objectives: The aim of this study was to assess the safety and efficacy of a new subxiphoid hybrid epicardial-endocardial atrial fibrillation (AF) ablation and left atrial appendage (LAA) ligation approach for the treatment of persistent AF., Background: Surgical hybrid ablation procedures have shown promise for maintaining sinus rhythm versus catheter ablation but are associated with increased periprocedural adverse events., Methods: Patients with symptomatic persistent AF (n = 33, mean age 64 ± 9 years, 25 men) who had antiarrhythmic drug therapy or prior catheter ablation was unsuccessful were referred for hybrid epicardial-endocardial AF ablation and LAA exclusion. LAA closure was confirmed by transesophageal echocardiographic Doppler flow and/or computed tomographic angiography 1 to 3 months post-ligation. The incidence of atrial tachycardia or AF recurrence, LAA closure, thromboembolic events, and post-operative complications were assessed., Results: All 33 patients underwent successful LAA ligation with epicardial ablation of the posterior left atrial wall, as well as endocardial pulmonary vein isolation and cavotricuspid isthmus ablation. Freedom from atrial tachycardia or AF was 91% (20 of 22 patients) at 6 months, 90% (18 of 20 patients) at 12 months, 92% (11 of 12 patients) at 18 months, and 92% (11 of 12) at 24 months. There were no acute periprocedural complications (<7 days). Thirty-day adverse events included 2 patients with pericardial effusion requiring pericardiocentesis and 1 incisional hernia repair. There were no long-term complications, strokes, or deaths. LAA ligation was complete in 27 of 33 subjects (82%), with 6 subjects having leaks of <5 mm., Conclusions: Subxiphoid hybrid epicardial-endocardial ablation with LAA ligation is feasible, safe, and effective. Future prospective studies are needed to validate these initial findings., Competing Interests: Author Disclosures Dr. Lee is a consultant for and equity holder in SentreHEART/AtriCure. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

A 49-year-old female with congenitally corrected (or levo-) transposition of the great arteries complicated by nonischemic cardiomyopathy presented for worsening heart failure despite guideline-directed medical therapy and was found to be in cardiogenic shock. She successfully underwent ventricular assist device placement with a HeartMate III to her systemic right ventricle as a bridge to transplantation.

Objective: Morbidity due to sternotomy continues to be a significant clinical problem. Poor approximation of the sternum may lead to complications such as sternal dehiscence, infection, and pain. A device to assist in tensioning and twisting standard steel wires during sternal closure has been developed (TORQ sternal closure device). Manually tightened interrupted wire closures were compared with those tightened and secured with the aid of the device. Performance of the device was assessed clinically., Methods: Four cardiovascular surgeons performed manual and device-assisted closures on a biofidelic model. Closure force was measured to determine the residual force and its intraoperator variation. A retrospective review of patients treated before and after the introduction of the device was conducted. Predicted and actual outcomes were compared for the two groups (manual closure and device-assisted closure)., Results: Biomechanical testing measured a 75% increase in residual closure force (P < 0.001) and a significant reduction in the variability of the closure force (P = 0.045) for device-assisted closures compared with manual closures. In the retrospective study, 3 of 173 manually closed patients had sterile sternal dehiscence and 1 of 173 had a deep sternal wound infection. In the device closure group, 2 of 127 had a sterile sternal dehiscence and no deep sternal wound infections were reported. No other device-related serious adverse events were reported., Conclusions: Biomechanical data showed stronger, more consistent closure forces with the device. The retrospective data attest to the performance of the device.