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1.
J Cardiothorac Vasc Anesth ; 37(9): 1579-1590, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37355415

RESUMEN

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.


Asunto(s)
Lesión Renal Aguda , Procedimientos Quirúrgicos Cardíacos , Humanos , Adulto , Consenso , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/epidemiología , Lesión Renal Aguda/etiología , Riñón , Resultado del Tratamiento , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Factores de Riesgo
2.
Anesth Analg ; 135(3): 653-658, 2022 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-35110517

RESUMEN

A tool for collecting and analyzing morphine milligram equivalents (MMEs) can be used to overcome barriers to situational awareness around opioid utilization in the setting of multimodal pain management. Our software application (App) has facilitated data collection, analysis, and benchmarking in a manner that is not logistically feasible using manual methods. Real-time postoperative tracking of MME over the course of an episode of care can be prohibitively labor-intensive, and teams must have practical strategies to overcome this obstacle. In view of the link between the magnitude of opioid prescriptions at discharge and persistent opioid use after cardiac surgery, we believe that improving situational awareness among the patient care team is a vital first step in reducing opioid dependence after cardiac surgery.


Asunto(s)
Analgésicos Opioides , Trastornos Relacionados con Opioides , Analgésicos Opioides/efectos adversos , Concienciación , Humanos , Trastornos Relacionados con Opioides/diagnóstico , Trastornos Relacionados con Opioides/epidemiología , Trastornos Relacionados con Opioides/prevención & control , Manejo del Dolor/efectos adversos , Manejo del Dolor/métodos , Dolor Postoperatorio/diagnóstico , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/etiología , Pautas de la Práctica en Medicina , Estudios Retrospectivos
3.
J Cardiothorac Vasc Anesth ; 36(1): 109-117, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34602324

RESUMEN

OBJECTIVE: The aim of this survey was to describe existing perioperative care standards and best practices in the Netherlands and Belgium. DESIGN: An online survey was followed up by an in-depth personal interview. The main outcomes were the existing standards of perioperative care for patients undergoing cardiac surgery. SETTING: The online survey and subsequent interviews were targeted to one representative in the intensive care unit (ICU), cardiac surgery, and anesthesiology department from each cardiac surgical center in the Netherlands and Belgium. PARTICIPANTS: A representative intensive care physician, cardiac surgeon, and cardiac anesthesiologist. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The response rate was 60% (71% for the Netherlands, and 44% in Belgium). Agreement across centers was found for discontinuation of proton-pump inhibitors (80%) and avoiding intra- and postoperative (92%) nonsteroidal antiinflammatory drugs. Additionally, 98% of respondents stated that physiotherapy should be started immediately in the ICU. Major divergence was found for elements such as the discontinuation of angiotensin-converting enzyme inhibitors (55%) or the postoperative use of chest support vests (44%). CONCLUSIONS: The authors demonstrated a wide range of different local protocols. Strategies differed among disciplines, hospitals, and countries. This emphasized the need for the implementation of a more universal protocol to further reduce variance and improve recovery practices. This nationwide survey was the first of its kind simultaneously studying best practices for cardiac surgery through the entire care pathway at the advent of Enhanced Recovery After Surgery (ERAS) Cardiac implementation. A multinational randomized controlled trial to test the implementation of an evidence-based ERAS Cardiac protocol is the next step to pave the way for further outcome improvements in this high-risk population.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Complicaciones Posoperatorias , Bélgica , Humanos , Tiempo de Internación , Países Bajos , Atención Perioperativa , Encuestas y Cuestionarios
4.
World J Surg ; 45(4): 917-925, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33521878

RESUMEN

BACKGROUND: Despite the emergence of Enhanced Recovery Protocols (ERPs) in cardiac surgery, there is no consensus on the essential elements for data reporting for quality improvement efforts, as well as accountability and standardization of outcome reporting across institutions. The aim of this study was to establish a consensus on essential data elements for cardiac ERAS®. METHODS: A 2-round modified Delphi technique was utilized based on existing recommendations from the recently published ERAS® cardiac surgery consensus guidelines. Round 1 included a steering committee of 10 experts who oversaw formulation of a focused list of data elements into 3 main areas: Preoperative, intraoperative and postoperative. Round 2 consisted of a multidisciplinary, multinational, heterogenous group of 50 voting experts from across the United States and Europe. All participants evaluated their level of agreement with each data element using a 5-point Likert scale with consensus threshold of 70%. RESULTS: In round 1, 17 data elements were considered essential (consensus > = 70%, either positive or negative) and 6 were considered marginal (consensus < = 70%, either positive or negative). In round 2, positive consensus was achieved for 15/17 (88.2%) data elements in the essential category, and all six data elements (100%) in the marginal category, indicating a high level of overall agreement. CONCLUSION: This initial study, which identified 21 key data elements for collection in an ERAS® cardiac program, will aid clinicians in establishing a framework for evaluating the quality of their contemporary ERP processes and will allow acquisition of data to help benchmark performance metrics between hospitals.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Consenso , Técnica Delphi , Europa (Continente) , Humanos , Periodo Posoperatorio
5.
J Card Surg ; 36(9): 3040-3051, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34118080

RESUMEN

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has had an unprecedented impact on health care and cardiac surgery. We report cardiac surgeons' concerns, perceptions, and responses during the COVID-19 pandemic. METHODS: A detailed survey was sent to recruit participating adult cardiac surgery centers in North America. Data regarding cardiac surgeons' perceptions and changes in practice were analyzed. RESULTS: Our study comprises 67 institutions with diverse geographic distribution across North America. Nurses were most likely to be redeployed (88%), followed by advanced care practitioners (69%), trainees (28%), and surgeons (25%). Examining surgeon concerns in regard to COVID-19, they were most worried with exposing their family to COVID-19 (81%), followed by contracting COVID-19 (68%), running out of personal protective equipment (PPE) (28%), and hospital resources (28%). In terms of PPE conservation strategies among users of N95 respirators, nearly half were recycling via decontamination with ultraviolet light (49%), followed by sterilization with heat (13%) and at home or with other modalities (13%). Reuse of N95 respirators for 1 day (22%), 1 week (21%) or 1 month (6%) was reported. There were differences in adoption of methods to conserve N95 respirators based on institutional pandemic phase and COVID-19 burden, with higher COVID-19 burden institutions more likely to resort to PPE conservation strategies. CONCLUSIONS: The present study demonstrates the impact of COVID-19 on North American cardiac surgeons. Our study should stimulate further discussions to identify optimal solutions to improve workforce preparedness for subsequent surges, as well as facilitate the navigation of future healthcare crises.


Asunto(s)
COVID-19 , Cirujanos , Adulto , Descontaminación , Humanos , Pandemias , Percepción , SARS-CoV-2
6.
Crit Care ; 23(1): 225, 2019 06 20.
Artículo en Inglés | MEDLINE | ID: mdl-31221200

RESUMEN

BACKGROUND: The first FDA-approved test to assess risk for acute kidney injury (AKI), [TIMP-2]•[IGFBP7], is clinically available in many parts of the world, including the USA and Europe. We sought to understand how the test is currently being used clinically. METHODS: We invited a group of experts knowledgeable on the utility of this test for kidney injury to a panel discussion regarding the appropriate use of the test. Specifically, we wanted to identify which patients would be appropriate for testing, how the results are interpreted, and what actions would be taken based on the results of the test. We used a modified Delphi method to prioritize specific populations for testing and actions based on biomarker test results. No attempt was made to evaluate the evidence in support of various actions however. RESULTS: Our results indicate that clinical experts have developed similar practice patterns for use of the [TIMP-2]•[IGFBP7] test in Europe and North America. Patients undergoing major surgery (both cardiac and non-cardiac), those who were hemodynamically unstable, or those with sepsis appear to be priority patient populations for testing kidney stress. It was agreed that, in patients who tested positive, management of potentially nephrotoxic drugs and fluids would be a priority. Patients who tested negative may be candidates for "fast-track" protocols. CONCLUSION: In the experience of our expert panel, biomarker testing has been a priority after major surgery, hemodynamic instability, or sepsis. Our panel members reported that a positive test prompts management of nephrotoxic drugs as well as fluids, while patients with negative results are considered to be excellent candidates for "fast-track" protocols.


Asunto(s)
Lesión Renal Aguda/diagnóstico , Biomarcadores/análisis , Lesión Renal Aguda/clasificación , Biomarcadores/sangre , Testimonio de Experto , Humanos , Proteínas de Unión a Factor de Crecimiento Similar a la Insulina/análisis , Proteínas de Unión a Factor de Crecimiento Similar a la Insulina/sangre , Inhibidor Tisular de Metaloproteinasa-2/análisis , Inhibidor Tisular de Metaloproteinasa-2/sangre
10.
Ann Thorac Surg ; 2024 Jun 13.
Artículo en Inglés | MEDLINE | ID: mdl-38878947

RESUMEN

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.

11.
JTCVS Open ; 18: 118-122, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38690434

RESUMEN

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.

12.
Artículo en Inglés | MEDLINE | ID: mdl-38574802

RESUMEN

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.

13.
Heart ; 2024 Apr 22.
Artículo en Inglés | MEDLINE | ID: mdl-38649264

RESUMEN

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.

14.
Ann Thorac Surg ; 117(4): 669-689, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38284956

RESUMEN

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.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Recuperación Mejorada Después de la Cirugía , Cirujanos , Cirugía Torácica , Humanos , Atención Perioperativa/métodos , Procedimientos Quirúrgicos Cardíacos/métodos
15.
Life Sci ; 351: 122841, 2024 Aug 15.
Artículo en Inglés | MEDLINE | ID: mdl-38897349

RESUMEN

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.


Asunto(s)
Antiinflamatorios , Procedimientos Quirúrgicos Cardíacos , Selenio , Humanos , Masculino , Femenino , Anciano , Procedimientos Quirúrgicos Cardíacos/métodos , Selenio/administración & dosificación , Selenio/farmacología , Método Doble Ciego , Persona de Mediana Edad , Estudios Prospectivos , Antiinflamatorios/farmacología , Antiinflamatorios/administración & dosificación , Antiinflamatorios/uso terapéutico , Recuperación de la Función/efectos de los fármacos , Suplementos Dietéticos , Antioxidantes/administración & dosificación , Antioxidantes/farmacología , Estrés Oxidativo/efectos de los fármacos
16.
Innovations (Phila) ; 18(1): 41-48, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36803288

RESUMEN

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.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Tubos Torácicos , Humanos , Drenaje , Encuestas y Cuestionarios
17.
Ann Thorac Surg ; 115(6): 1411-1419, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36526008

RESUMEN

BACKGROUND: We aimed to elucidate current national multiarterial coronary bypass grafting practice patterns and assess perioperative outcomes. METHODS: Isolated primary nonemergent/nonsalvage coronary artery bypass grafting patients with at least 1 internal thoracic artery and 2 or more grafts in The Society of Thoracic Surgery Adult Cardiac Surgery Database (2018-2019) were divided into 3 cohorts: single-arterial, bilateral internal thoracic artery (BITA), and radial artery multiarterial grafting. Observed-to-expected ratios based on 2017 Society of Thoracic Surgery risk models were derived for 30-day perioperative mortality, composite major morbidity and mortality, and deep sternal wound infections for each grafting group overall and as a function of institutional multiarterial case volumes per study period: low (<10), intermediate (11-30), and high (>30). RESULTS: A total of 281,515 patients (BITA, 15,663 [5.6%]; radial, 23,905 [8.5%]) at 1013 centers showed distinct geographic grafting patterns: BITA and radial multiarterial grafting rates were lowest in the South (4% and 6%, respectively) and highest in the Northeast (9% and 11%, respectively). The median institutional number of BITA and radial cases per study period was 4 and 7, with only 14% and 21% of institutions performing >30 BITA and radial multiarterial cases per study period, respectively. The observed-to-expected mortality for single-arterial bypass grafting was similar to multiarterial: single-arterial, 1.00 (95% CI, 0.98-1.03); BITA, 0.98 (95% CI, 0.84-1.13; P = .711); and radial, 0.96 (95% CI, 0.86-1.07; P = .818). Observed-to-expected mortality and composite major morbidity and mortality were lower at high vs low multiarterial case-volume centers: 0.91 (95% CI, 0.75-1.08) vs 1.30 (95% CI, 0.89-1.79; P = .048) and 1.06 (95% CI, 0.99-1.13) vs 1.51 (95% CI, 1.32-1.71; P < .001), respectively, for BITA, and 0.82 (95% CI, 0.87-1.30) vs 1.67 (95% CI, 1.21-2.21; P < .001) and 0.91 (95% CI, 0.93-1.08) vs 1.42 (95% CI, 1.24-1.61; P < .001), respectively, for radial. CONCLUSIONS: Multiarterial bypass grafting remains underused and limited to select centers. Worse outcomes at low-volume BITA and radial institutions document a case-volume outcomes effect. Additional studies are warranted to improve multiarterial outcomes at low-volume institutions.


Asunto(s)
Enfermedad de la Arteria Coronaria , Arterias Mamarias , Cirujanos , Cirugía Torácica , Humanos , Adulto , Estados Unidos/epidemiología , Enfermedad de la Arteria Coronaria/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Puente de Arteria Coronaria , Arterias Mamarias/trasplante
18.
JTCVS Open ; 14: 205-213, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37425466

RESUMEN

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.

19.
Ann Thorac Surg ; 116(5): 944-953, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37308066

RESUMEN

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.

20.
Kidney Int Rep ; 8(7): 1407-1416, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37441472

RESUMEN

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.

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