Cardiac Surgical Bleeding, Transfusion and Quality Metrics: Joint Consensus Statement by the Enhanced Recovery After Surgery Cardiac Society and Society for the Advancement of Patient Blood Management.

BACKGROUND: Excessive perioperative bleeding is associated with major complications in cardiac surgery, resulting in increased morbidity, mortality and cost. METHODS: An international expert panel was convened to develop consensus statements on the control of bleeding and management of transfusion, and to suggest key quality metrics for cardiac surgical bleeding. The panel reviewed relevant literature from the previous 10 years and used a modified RAND Delphi methodology to achieve consensus. RESULTS: Thirty consensus statements in 8 categories were developed, including prioritizing control of bleeding, pre-chest closure checklists and the need for additional quality indicators beyond re-exploration rate, such as time to re-exploration. Consensus was also reached on the need for a universal definition of excessive bleeding, the use of antifibrinolytics, optimal cessation of antithrombotic agents, and preoperative risk scoring based on patient and procedural factors to identify those at greatest risk of excessive bleeding. Furthermore, there is a need for an objective bleeding scale based on the volume and rapidity of blood loss accompanied by viscoelastic management algorithms and standardized, patient-centered blood management strategies reflecting an interdisciplinary approach to quality improvement. CONCLUSIONS: Prioritizing the timely control and management of bleeding is essential to improving patient outcomes in cardiac surgery. To this end, a cardiac surgical bleeding quality metric that is more comprehensive than re-exploration rate alone is needed. Similarly, interdisciplinary quality initiatives that seek to implement enhanced quality indicators will likely lead to improved patient care and outcomes.

Maximizing Minimally Invasive Cardiac Surgery With Enhanced Recovery (ERAS).

We convened a group of cardiac surgeons, intensivists, and anesthesiologists with extensive experience in minimally invasive cardiac surgery (MICS) and perioperative care to identify the essential elements of a MICS program and the relationship with Enhanced Recovery After Surgery (ERAS). The MICS incision should minimize tissue invasion without compromising surgical goals. MICS also requires safe management of hemodynamics and preservation of cardiac function, which we have termed myocardial management. Finally, comprehensive perioperative care through an ERAS program should be provided to allow patients to achieve optimal recovery. Therefore, we propose that MICS requires 3 elements: (1) a less invasive surgical incision (non-full sternotomy), (2) optimized myocardial management, and (3) ERAS. We contend that the full benefit of MICS can be achieved only by also utilizing an ERAS platform.

Early Initiation of Guideline-Directed Medical Therapy for Heart Failure After Cardiac Surgery.

There is an evolving role for guideline-directed medical therapy (GDMT) in managing heart failure with reduced ejection fraction after cardiac surgery. GDMT is based on the use of pharmacologic agents from each of 4 distinct drug classes, also known as the 4 pillars of heart failure therapy: ß-blockers, renin-angiotensin system inhibitors, often paired with neprilysin inhibitors, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors. Despite the demonstrated benefits of GDMT in reducing mortality and hospitalization rates in the nonsurgical literature, there is conspicuous underuse of GDMT after cardiac surgery. The lack of published literature and practical challenges surrounding the timing for initiation of GDMT in the immediate postoperative period has limited standardized implementation strategies. A multidisciplinary approach will be necessary to assist in initiating, titrating, and monitoring the response to these therapies in patients with heart failure with reduced ejection fraction after cardiac surgery.

The effect of a selenium-based anti-inflammatory strategy on postoperative functional recovery in high-risk cardiac surgery patients - A nested sub-study of the sustain CSX trial.

AIM: The cardiac surgery-related ischemia-reperfusion-related oxidative stress triggers the release of cytotoxic reactive oxygen and nitrogen species, contributing to organ failure and ultimately influencing patients' short- and long-term outcomes. Selenium is an essential co-factor for various antioxidant enzymes, thereby contributing to the patients' endogenous antioxidant and anti-inflammatory defense mechanisms. Given these selenium's pleiotropic functions, we investigated the effect of a high-dose selenium-based anti-inflammatory perioperative strategy on functional recovery after cardiac surgery. MATERIALS AND METHODS: This prospective study constituted a nested sub-study of the SUSTAIN CSX trial, a double-blinded, randomized, placebo-controlled multicenter trial to investigate the impact of high-dose selenium supplementation on high-risk cardiac surgery patients' postoperative recovery. Functional recovery was assessed by 6-min walk distance, Short Form-36 (SF-36) and Barthel Index questionnaires. KEY FINDINGS: 174 patients were included in this sub-study. The mean age (SD) was 67.3 (8.9) years, and 78.7 % of the patients were male. The mean (SD) predicted 30-day mortality by the European System for Cardiac Operative Risk Evaluation II score was 12.6 % (9.4 %). There was no difference at hospital discharge and after three months in the 6-min walk distance between the selenium and placebo groups (131 m [IQR: not performed - 269] vs. 160 m [IQR: not performed - 252], p = 0.80 and 400 m [IQR: 299-461] vs. 375 m [IQR: 65-441], p = 0.48). The SF-36 and Barthel Index assessments also revealed no clinically meaningful differences between the selenium and placebo groups. SIGNIFICANCE: A perioperative anti-inflammatory strategy with high-dose selenium supplementation did not improve functional recovery in high-risk cardiac surgery patients.

Enhanced Recovery After Surgery Cardiac Society turnkey order set for prevention and management of postoperative atrial fibrillation after cardiac surgery: Proceedings from the American Association for Thoracic Surgery ERAS Conclave 2023.

Background: Postoperative atrial fibrillation (POAF) is a prevalent complication following cardiac surgery that is associated with increased adverse events. Several guidelines and expert consensus documents have been published addressing the prevention and management of POAF. We aimed to develop an order set to facilitate widespread implementation and adoption of evidence-based practices for POAF following cardiac surgery. Methods: Subject matter experts were consulted to translate existing guidelines and literature into a sample turnkey order set (TKO) for POAF. Orders derived from consistent class I or IIA or equivalent recommendations across referenced guidelines and consensus manuscripts appear in the TKO in bold type. Selected orders that were inconsistently class I or IIA, class IIB, or supported by published evidence appear in italic type. Results: Preoperatively, the recommendation is to screen patients for paroxysmal or chronic atrial fibrillation and initiate appropriate treatment based on individual risk stratification for the development of POAF. This may include the administration of beta-blockers or amiodarone, tailored to the patient's specific risk profile. Intraoperatively, surgical interventions such as posterior pericardiotomy should be considered in selected patients. Postoperatively, it is crucial to focus on electrolyte normalization, implementation strategies for rate or rhythm control, and anticoagulation management. These comprehensive measures aim to optimize patient outcomes and reduce the occurrence of POAF following cardiac surgery. Conclusions: Despite the well-established benefits of implementing a multidisciplinary care pathway for POAF in cardiac surgery, its adoption and implementation remain inconsistent. We have developed a readily applicable order set that incorporates recommendations from existing guidelines.

Enhanced Recovery After Surgery Cardiac Society turnkey order set for surgical-site infection prevention: Proceedings from the American Association for Thoracic Surgery ERAS Conclave 2023.

OBJECTIVES: Surgical-site infections (SSIs) after cardiac surgery increase morbidity and mortality, consume health care resources, impair recovery, and diminish patients' quality of life. Numerous guidelines and expert consensus documents have been published to address the prevention and management of SSIs. Our objective is to integrate these documents into an order set that will facilitate the adoption and implementation of evidence-based best practices for preventing and managing SSIs after cardiac surgery. METHODS: Subject matter experts were consulted to translate existing guidelines and literature into a sample turnkey order set for SSI reduction. Orders derived from consistent class I, IIA, or equivalent recommendations across referenced guidelines and consensus manuscripts appear in the turnkey order set in bold type. Selected orders that were inconsistent class I or IIA, class IIB or otherwise supported by published evidence, were also included in italicized type. RESULTS: Preventative care begins with the preoperative identification of both modifiable and nonmodifiable SSI risks by health care providers. Assessment tools can be used to assist in identifying patients at a high risk of SSI. Preoperative recommendations include screening for and treating Staphylococcus aureus nasal carriage. Intraoperatively, tailored prophylactic intravenous antibiotics and maintaining blood glucose levels below 180 mg/dL are essential elements. Postoperative care includes maintaining normothermia, glucose control and patient engagement. CONCLUSIONS: Despite the well-documented advantages of a multidisciplinary care pathway for SSI in cardiac surgery, there are inconsistencies in its adoption and implementation. This article provides an order set that incorporates recommendations from existing guidelines to prevent SSI in the cardiac surgical population.

Sarcopenia and aortic valve disease.

Valvular heart disease, including calcific or degenerative aortic stenosis (AS), is increasingly prevalent among the older adult population. Over the last few decades, treatment of severe AS has been revolutionised following the development of transcatheter aortic valve replacement (TAVR). Despite improvements in outcomes, older adults with competing comorbidities and geriatric syndromes have suboptimal quality of life outcomes, highlighting the cumulative vulnerability that persists despite valve replacement. Sarcopenia, characterised by loss of muscle strength, mass and function, affects 21%-70% of older adults with AS. Sarcopenia is an independent predictor of short-term and long-term outcomes after TAVR and should be incorporated as a prognostic marker in preprocedural planning. Early diagnosis and treatment of sarcopenia may reduce morbidity and mortality and improve quality of life following TAVR. The adverse effects of sarcopenia can be mitigated through resistance training and optimisation of nutritional status. This is most efficacious when administered before sarcopenia has progressed to advanced stages. Management should be individualised based on the patient's wishes/preferences, care goals and physical capability. Exercise during the preoperative waiting period may be safe and effective in most patients with severe AS. However, future studies are needed to establish the benefits of prehabilitation in improving quality of life outcomes after TAVR procedures.

Perioperative Care in Cardiac Surgery: A Joint Consensus Statement by the Enhanced Recovery After Surgery (ERAS) Cardiac Society, ERAS International Society, and The Society of Thoracic Surgeons (STS).

Enhanced Recovery After Surgery (ERAS) programs have been shown to lessen surgical insult, promote recovery, and improve postoperative clinical outcomes across a number of specialty operations. A core tenet of ERAS involves the provision of protocolized evidence-based perioperative interventions. Given both the growing enthusiasm for applying ERAS principles to cardiac surgery and the broad scope of relevant interventions, an international, multidisciplinary expert panel was assembled to derive a list of potential program elements, review the literature, and provide a statement regarding clinical practice for each topic area. This article summarizes those consensus statements and their accompanying evidence. These results provide the foundation for best practice for the management of the adult patient undergoing cardiac surgery.

ERAS Cardiac Society turnkey order set for patient blood management: Proceedings from the AATS ERAS Conclave 2023.

OBJECTIVES: There are multiple published guidelines on comprehensive patient blood management (PBM), centered on the 3 pillars of PBM: managing preoperative anemia, minimizing blood loss, and tolerating intraoperative/postoperative anemia. We sought to create an order set to facilitate widespread implementation of evidence-based PBM for cardiac surgery patients. METHODS: Subject matter experts were consulted to translate existing guidelines and literature into a sample turnkey order set (TKO) for PBM. Orders derived from consistent class I, class IIA, or equivalent recommendations across referenced guidelines and consensus manuscripts appear in the TKO in bold type. Selected orders that were inconsistently class I or IIA, class IIB, or supported by published evidence are presented in italic type. RESULTS: Preoperatively, there are strong recommendations to screen and treat preoperative anemia with iron replacement and erythropoietin and to discontinue dual antiplatelet therapy if the patient can safely wait for surgery. Intraoperative orders outline the routine use of an antifibrinolytic agent, cell saver, point of care viscoelastic testing, and use of a standard transfusion algorithm. The order set also reflects strong recommendations intraoperatively and postoperatively for agreed-upon hemoglobin thresholds to consider transfusion of packed red blood cells. A hemoglobin threshold should be adopted according to local team consensus and should trigger a discussion regarding transfusion. CONCLUSIONS: The benefit of a multidisciplinary PBM care pathway in cardiac surgery has been well established, yet implementation remains variable. Using recommendations from existing guidelines, we have created a TKO to facilitate the implementation of PBM.

State of the art: Proceedings of the American Association for Thoracic Surgery Enhanced Recovery After Cardiac Surgery Summit.

Despite the benefits established for multiple surgical specialties, enhanced recovery after surgery has been underused in cardiac surgery. A cardiac enhanced recovery after surgery summit was convened at the 102nd American Association for Thoracic Surgery annual meeting in May 2022 for experts to convey key enhanced recovery after surgery concepts, best practices, and applicable results for cardiac surgery. Topics included implementation of enhanced recovery after surgery, prehabilitation and nutrition, rigid sternal fixation, goal-directed therapy, and multimodal pain management.

The Effects of Peroxisome Proliferator-Activated Receptor-Delta Modulator ASP1128 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.

Introduction: Peroxisome proliferator-activated receptor δ (PPARδ) plays a central role in modulating mitochondrial function in ischemia-reperfusion injury. The novel PPARδ modulator, ASP1128, was evaluated. Methods: A randomized, double-blind, placebo-controlled, biomarker assignment-driven, multicenter study was performed in adult patients at risk for acute kidney injury (AKI) following cardiac surgery, examining efficacy and safety of a 3-day, once-daily intravenous dose of 100 mg ASP1128 versus placebo (1:1). AKI risk was based on clinical characteristics and postoperative urinary biomarker (TIMP2)•(IGFBP7). The primary end point was the proportion of patients with AKI based on serum creatinine within 72 hours postsurgery (AKI-SCr72h). Secondary endpoints included the composite end point of major adverse kidney events (MAKE: death, renal replacement therapy, and/or ≥25% reduction of estimated glomerular filtration rate [eGFR]) at days 30 and 90). Results: A total of 150 patients were randomized and received study medication (81 placebo, 69 ASP1128). Rates of AKI-SCr72h were 21.0% and 24.6% in the placebo and ASP1128 arms, respectively (P = 0.595). Rates of moderate/severe AKI (stage 2/3 AKI-SCr and/or stage 3 AKI-urinary output criteria) within 72 hours postsurgery were 19.8% and 23.2%, respectively (P = 0.609). MAKE occurred within 30 days in 11.1% and 13.0% in the placebo and ASP1128 arms (P = 0.717), respectively; and within 90 days in 9.9% and 15.9% in the placebo and ASP1128 arms (P = 0.266), respectively. No safety issues were identified with ASP1128 treatment, but rates of postoperative atrial fibrillation were lower (11.6%) than in the placebo group (29.6%). Conclusion: ASP1128 was safe and well-tolerated in patients at risk for AKI following cardiac surgery, but it did not show efficacy in renal endpoints.

Long-term Outcomes and Anticoagulation in Mitral Valve Surgery-A Report From The Society of Thoracic Surgeons Database.

BACKGROUND: Anticoagulation after bioprosthetic mitral valve (MV) replacement (BMVR) and repair (MVrep) is controversial. We explore outcomes among BMVR and MVrep patients in The Society of Thoracic Surgeons Adult Cardiac Surgery Database based on discharge anticoagulation status. METHODS: BMVR and MVrep patients aged ≥65 years in The Society of Thoracic Surgeons Adult Cardiac Surgery Database were linked to the Centers for Medicare and Medicaid Services claims database. Long-term mortality, ischemic stroke, bleeding, and a composite of the primary end points were compared as a function of anticoagulation. Hazard ratios (HRs) were calculated using multivariable Cox regression. RESULTS: A total of 26,199 BMVR and MVrep patients were linked to the Centers for Medicare and Medicaid Services database; of these, 44%, 4%, and 52% were discharged on warfarin, non-vitamin K-dependent anticoagulant (NOAC), and no anticoagulation (no-AC; reference), respectively. Warfarin was associated with increased bleeding in the overall study cohort (HR, 1.38; 95% CI 1.26-1.52) and in the BMVR (HR, 1.32; 95% CI, 1.13-1.55) and MVrep subcohorts (HR, 1.42; 95% CI, 1.26-1.60). Warfarin was associated with decreased mortality only among BMVR patients (HR, 0.87; 95% CI, 0.79-0.96). Stroke and the composite outcome did not differ across cohorts with warfarin. NOAC use was associated with increased mortality (HR, 1.33; 95% CI 1.11-1.59), bleeding (HR, 1.37; 95% CI, 1.07-1.74), and the composite outcome (HR, 1.26; 95% CI, 1.08-1.47). CONCLUSIONS: Anticoagulation was used in fewer than half of mitral valve operations. In MVrep patients, warfarin was associated with increased bleeding and was not protective against stroke or mortality. In BMVR patients, warfarin was associated with a modest survival benefit, increased bleeding, and equivalent stroke risk. NOAC was associated with increased adverse outcomes.

Adult Cardiac Surgery-Associated Acute Kidney Injury: Joint Consensus Report.

OBJECTIVES: Acute kidney injury (AKI) is increasingly recognized as a source of poor patient outcomes after cardiac surgery. The purpose of the present report is to provide perioperative teams with expert recommendations specific to cardiac surgery-associated AKI (CSA-AKI). METHODS: This report and consensus recommendations were developed during a joint, in-person, multidisciplinary conference with the Perioperative Quality Initiative and the Enhanced Recovery After Surgery Cardiac Society. Multinational practitioners with diverse expertise in all aspects of cardiac surgical perioperative care, including clinical backgrounds in anesthesiology, surgery and nursing, met from October 20 to 22, 2021, in Sacramento, California, and used a modified Delphi process and a comprehensive review of evidence to formulate recommendations. The quality of evidence and strength of each recommendation were established using the Grading of Recommendations Assessment, Development, and Evaluation methodology. A majority vote endorsed recommendations. RESULTS: Based on available evidence and group consensus, a total of 13 recommendations were formulated (4 for the preoperative phase, 4 for the intraoperative phase, and 5 for the postoperative phase), and are reported here. CONCLUSIONS: Because there are no reliable or effective treatment options for CSA-AKI, evidence-based practices that highlight prevention and early detection are paramount. Cardiac surgery-associated AKI incidence may be mitigated and postsurgical outcomes improved by focusing additional attention on presurgical kidney health status; implementing a specific cardiopulmonary bypass bundle; using strategies to maintain intravascular euvolemia; leveraging advanced tools such as the electronic medical record, point-of-care ultrasound, and biomarker testing; and using patient-specific, goal-directed therapy to prioritize oxygen delivery and end-organ perfusion over static physiologic metrics.

Study protocol of a phase 2, randomised, placebo-controlled, double-blind, adaptive, parallel group clinical study to evaluate the efficacy and safety of recombinant alpha-1-microglobulin in subjects at high risk for acute kidney injury following open-chest cardiac surgery (AKITA trial).

INTRODUCTION: Acute kidney injury (AKI) is a common complication after cardiac surgery (CS) and is associated with adverse short-term and long-term outcomes. Alpha-1-microglobulin (A1M) is a circulating glycoprotein with antioxidant, heme binding and mitochondrial-protective mechanisms. RMC-035 is a modified, more soluble, variant of A1M and has been proposed as a novel targeted therapeutic protein to prevent CS-associated AKI (CS-AKI). RMC-035 was considered safe and generally well tolerated when evaluated in four clinical phase 1 studies. METHODS AND ANALYSIS: This is a phase 2, randomised, double-blind, adaptive design, parallel group clinical study that evaluates RMC-035 compared with placebo in approximately 268 cardiac surgical patients at high risk for CS-AKI. RMC-035 is administered as an intravenous infusion. In total, five doses will be given. Dosing is based on presurgery estimated glomerular filtration rate (eGFR), and will be either 1.3 or 0.65 mg/kg.The primary study objective is to evaluate whether RMC-035 reduces the incidence of postoperative AKI, and key secondary objectives are to evaluate whether RMC-035 improves postoperative renal function compared with placebo. A blinded interim analysis with potential sample size reassessment is planned once 134 randomised subjects have completed dosing. An independent data monitoring committee will evaluate safety and efficacy data at prespecified intervals throughout the trial. The study is a global multicentre study at approximately 30 sites. ETHICS AND DISSEMINATION: The trial was approved by the joint ethics committee of the physician chamber Westfalen-Lippe and the University of Münster (code '2021-778 f-A') and subsequently approved by the responsible ethics committees/relevant institutional review boards for the participating sites. The study is conducted in accordance with Good Clinical Practice, the Declaration of Helsinki and other applicable regulations. Results of this study will be published in a peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: NCT05126303.

Chest Tube Management: Past, Present, and Future Directions for Developing Evidence-Based Best Practices.

In the field of modern cardiothoracic surgery, chest drainage has become ubiquitous and yet characterized by a wide variation in practice. Meanwhile, the evolution of chest drain technology has created gaps in knowledge that represent opportunities for new research to support the development of best practices in chest drain management. The chest drain is an indispensable tool in the recovery of the cardiac surgery patient. However, decisions about chest drain management-including those about type, material, number, maintenance of patency, and the timing of removal-are largely driven by tradition due to a scarcity of quality evidence. This narrative review surveys the available evidence regarding chest-drain management practices with the objective of highlighting scientific gaps, unmet needs, and opportunities for further research.