The Society of Thoracic Surgeons, The Society of Cardiovascular Anesthesiologists, and The American Society of ExtraCorporeal Technology: Clinical Practice Guidelines-Anticoagulation During Cardiopulmonary Bypass.

Despite more than a half century of "safe" cardiopulmonary bypass (CPB), the evidence base surrounding the conduct of anticoagulation therapy for CPB has not been organized into a succinct guideline. For this and other reasons, there is enormous practice variability relating to the use and dosing of heparin, monitoring heparin anticoagulation, reversal of anticoagulation, and the use of alternative anticoagulants. To address this and other gaps, The Society of Thoracic Surgeons, the Society of Cardiovascular Anesthesiologists, and the American Society of Extracorporeal Technology developed an Evidence Based Workgroup. This was a group of interdisciplinary professionals gathered to summarize the evidence and create practice recommendations for various aspects of CPB. To date, anticoagulation practices in CPB have not been standardized in accordance with the evidence base. This clinical practice guideline was written with the intent to fill the evidence gap and to establish best practices in anticoagulation therapy for CPB using the available evidence. To identify relevant evidence, a systematic review was outlined and literature searches were conducted in PubMed using standardized medical subject heading (MeSH) terms from the National Library of Medicine list of search terms. Search dates were inclusive of January 2000 to December 2015. The search yielded 833 abstracts, which were reviewed by two independent reviewers. Once accepted into the full manuscript review stage, two members of the writing group evaluated each of 286 full papers for inclusion eligibility into the guideline document. Ninety-six manuscripts were included in the final review. In addition, 17 manuscripts published before 2000 were included to provide method, context, or additional supporting evidence for the recommendations as these papers were considered sentinel publications. Members of the writing group wrote and developed recommendations based on review of the articles obtained and achieved more than two thirds agreement on each recommendation. The quality of information for a given recommendation allowed assessment of the level of evidence as recommended by the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Recommendations were written in the three following areas: (1) heparin dosing and monitoring for initiation and maintenance of CPB; (2) heparin contraindications and heparin alternatives; and (3) reversal of anticoagulation during cardiac operations. It is hoped that this guideline will serve as a resource and will stimulate investigators to conduct more research and to expand on the evidence base on the topic of anticoagulation therapy for CPB.

STS/SCA/AmSECT Clinical Practice Guidelines: Anticoagulation during Cardiopulmonary Bypass.

Despite more than a half century of "safe" cardiopulmonary bypass (CPB), the evidence base surrounding the conduct of anticoagulation for CPB has not been organized into a succinct guideline. For this and other reasons, there is enormous practice variability relating to the use and dosing of heparin, monitoring heparin anticoagulation, reversal of anticoagulation, and the use of alternative anticoagulants. To address this and other gaps, the Society of Thoracic Surgeons (STS), the Society of Cardiovascular Anesthesiologists (SCA), and the American Society of Extracorporeal Technology (AmSECT) developed an Evidence Based Workgroup. This was a group of interdisciplinary professionals gathered together to summarize the evidence and create practice recommendations for various aspects of CPB. To date, anticoagulation practices in CPB have not been standardized in accordance with the evidence base. This clinical practice guideline was written with the intent to fill the evidence gap and to establish best practices in anticoagulation for CPB using the available evidence. To identify relevant evidence a systematic review was outlined and literature searches were conducted in PubMed® using standardized MeSH terms from the National Library of Medicine list of search terms. Search dates were inclusive of January 2000 to December 2015. The search yielded 833 abstracts which were reviewed by two independent reviewers. Once accepted into the full manuscript review stage, two members of the writing group evaluated each of 286 full papers for inclusion eligibility into the guideline document. Ninety-six manuscripts were included in the final review. In addition, 17 manuscripts published prior to 2000 were included to provide method, context, or additional supporting evidence for the recommendations as these papers were considered sentinel publications. Members of the writing group wrote and developed recommendations based on review of the articles obtained and achieved more than two thirds agreement on each recommendation. The quality of information for a given recommendation allowed assessment of the level of evidence as recommended by the AHA/ACCF Task Force on Practice Guidelines. Recommendations were written in the three following areas 1) Heparin dosing and monitoring for initiation and maintenance of CPB, 2) Heparin contraindications and heparin alternatives, 3) Reversal of anticoagulation during cardiac operations. It is hoped that this guideline will serve as a resource and will stimulate investigators to conduct more research and expand upon the evidence base on the topic of anticoagulation for CPB.

The Society of Thoracic Surgeons, The Society of Cardiovascular Anesthesiologists, and The American Society of ExtraCorporeal Technology: Clinical Practice Guidelines for Cardiopulmonary Bypass--Temperature Management During Cardiopulmonary Bypass.

UNLABELLED: In order to improve our understanding of the evidence-based literature supporting temperature management during adult cardiopulmonary bypass, The Society of Thoracic Surgeons, the Society of Cardiovascular Anesthesiology and the American Society of ExtraCorporeal Technology tasked the authors to conduct a review of the peer-reviewed literature, including: 1) optimal site for temperature monitoring, 2) avoidance of hyperthermia, 3) peak cooling temperature gradient and cooling rate, and 4) peak warming temperature gradient and rewarming rate. Authors adopted the American College of Cardiology/American Heart Association method for development clinical practice guidelines, and arrived at the following recommendations: CLASS I RECOMMENDATIONS: a)The oxygenator arterial outlet blood temperature is recommended to be utilized as a surrogate for cerebral temperature measurement during CPB. (Class I, Level C) b)To monitor cerebral perfusate temperature during warming, it should be assumed that the oxygenator arterial outlet blood temperature under-estimates cerebral perfusate temperature. (Class I, Level C) c)Surgical teams should limit arterial outlet blood temperature to<37°C to avoid cerebral hyperthermia. (Class 1, Level C) d)Temperature gradients between the arterial outlet and venous inflow on the oxygenator during CPB cooling should not exceed 10°C to avoid generation of gaseous emboli. (Class 1, Level C) e)Temperature gradients between the arterial outlet and venous inflow on the oxygenator during CPB rewarming should not exceed 10°C to avoid out-gassing when blood is returned to the patient. (Class 1, Level C) CLASS IIa RECOMMENDATIONS: a)Pulmonary artery or nasopharyngeal temperature recording is reasonable for weaning and immediate post-bypass temperature measurement. (Class IIa, Level C)b)Rewarming when arterial blood outlet temperature ≥30° C: i.To achieve the desired temperature for separation from bypass, it is reasonable to maintain a temperature gradient between arterial outlet temperature and the venous inflow of≤4°C. (Class IIa, Level B) ii.To achieve the desired temperature for separation from bypass, it is reasonable to maintain a rewarming rate≤0.5°C/min. (Class IIa, Level B) NO RECOMMENDATION: No recommendation for a guideline is provided concerning optimal temperature for weaning from CPB due to insufficient published evidence.

The Society of Thoracic Surgeons, The Society of Cardiovascular Anesthesiologists, and The American Society of ExtraCorporeal Technology: Clinical Practice Guidelines for Cardiopulmonary Bypass--Temperature Management during Cardiopulmonary Bypass.

To improve our understanding of the evidence-based literature supporting temperature management during adult cardiopulmonary bypass, The Society of Thoracic Surgeons, the Society of Cardiovascular Anesthesiology and the American Society of ExtraCorporeal Technology tasked the authors to conduct a review of the peer-reviewed literature, including 1) optimal site for temperature monitoring, 2) avoidance of hyperthermia, 3) peak cooling temperature gradient and cooling rate, and 4) peak warming temperature gradient and rewarming rate. Authors adopted the American College of Cardiology/American Heart Association method for development clinical practice guidelines, and arrived at the following recommendation.

Attenuating the Systemic Inflammatory Response to Adult Cardiopulmonary Bypass: A Critical Review of the Evidence Base.

A wide range of pharmacological, surgical, and mechanical pump approaches have been studied to attenuate the systemic inflammatory response to cardiopulmonary bypass, yet no systematically based review exists to cover the scope of anti-inflammatory interventions deployed. We therefore conducted an evidence-based review to capture "self-identified" anti-inflammatory interventions among adult cardiopulmonary bypass procedures. To be included, trials had to measure at least one inflammatory mediator and one clinical outcome, specified in the "Outcomes 2010" consensus statement. Ninety-eight papers satisfied inclusion criteria and formed the basis of the review. The review identified 33 different interventions and approaches to attenuate the systemic inflammatory response. However, only a minority of papers (35 of 98 [35.7%]) demonstrated any clinical improvement to one or more of the predefined outcome measures (most frequently myocardial protection or length of intensive care unit stay). No single intervention was supported by strong level A evidence (multiple randomized controlled trials [RCTs] or meta-analysis) for clinical benefit. Interventions at level A evidence included off-pump surgery, minimized circuits, biocompatible circuit coatings, leukocyte filtration, complement C5 inhibition, preoperative aspirin, and corticosteroid prophylaxis. Interventions at level B evidence (single RCT) for minimizing inflammation included nitric oxide donors, C1 esterase inhibition, neutrophil elastase inhibition, propofol, propionyl-L-carnitine, and intensive insulin therapy. A secondary analysis revealed that suppression of at least one inflammatory marker was necessary but not sufficient to confer clinical benefit. The most effective interventions were those that targeted multiple inflammatory pathways. These observations are consistent with a "multiple hit" hypothesis, whereby clinically effective suppression of the systemic inflammatory response requires hitting multiple inflammatory targets simultaneously. Further research is warranted to evaluate if combinations of interventions that target multiple inflammatory pathways are capable of synergistically reducing inflammation and improving outcomes after cardiopulmonary bypass.

Factor IX complex for the treatment of severe bleeding after cardiac surgery.

BACKGROUND: Previous reports have been published on the use of recombinant Factor VIIa for intractable bleeding after cardiac surgery; however, there is limited information on the use of Factor IX Complex in this population. METHODS: A retrospective cohort study of adult patients who underwent cardiac surgery and experienced severe postoperative bleeding, defined as a mean chest tube output ≥300 mL/h. Primary outcomes were changes in chest tube output and blood product usage pre- and post-Factor IX Complex administration. RESULTS: Eleven patients received Factor IX Complex for severe postoperative bleeding. The mean dose of Factor IX Complex was 35 (13-52) units/kg. Chest tube output was significantly reduced after Factor IX Complex administration (mean pre-Factor IX Complex 381 ± 49 mL/h, mean post-Factor IX Complex 151 ± 38 mL/h; P = 0.003). Blood product usage decreased after Factor IX Complex but was not statistically significant (mean pre-Factor IX Complex 373 ± 81 mL/h, mean post-Factor IX Complex 212 ± 48 mL/h; P = 0.669). Adverse events included 1 pulmonary embolism (postoperative day 43) and 2 episodes of acute renal failure requiring dialysis (postoperative days 2 and 5). CONCLUSIONS: In this small group of patients, Factor IX Complex effectively controlled severe bleeding after cardiac surgery preventing the need for re-exploration.

Brain protection during cardiac surgery: circa 2012.

Brain injury during cardiac surgery can cause a potentially disabling syndrome consisting mainly of cognitive dysfunction but can manifest itself as symptoms and signs indistinguishable from frank stroke. The cause of the damage is mainly the result of emboli consisting of solid material such as clots or atherosclerotic plaque, fat, and/or gas. These emboli enter the cerebral circulation from the cardiopulmonary bypass machine, break off the aorta during manipulation, and enter the circulation from cardiac chambers. This damage can be prevented or at least minimized by avoiding aortic manipulation, filtering aortic inflow from the pump, preventing air from entering the pump plus careful deairing of the heart. Shed blood from the cardiotomy suction should be processed by a cell saver whenever possible. By doing these maneuvers, inflammation of the brain can be avoided. Long-term neurocognitive damage has been largely prevented in large series of patients having high-risk surgery, which makes these preventive measures worthwhile.

Cannula design reduces particulate and gaseous emboli during cardiopulmonary bypass for coronary revascularization.

PURPOSE: The incidence of neurocognitive deficits after coronary bypass surgery remains problematic, with atheroembolism being one of the major causes. External manipulation of aorta and the "sandblasting" effect of the high-velocity perfusion jet can cause dislodgement of atheromatous debris. DESCRIPTION: A new arterial cannula features a tip configuration that diffuses the flow through multiple outlets, providing reduced velocity and shear with one central and three diverted flow streams. EVALUATION: Between March 2007 and July 2008 twenty patients having isolated coronary artery bypass operations were instrumented with an Embolus Detection and Classification transducer. These data were compared to 43 patients from a previous study using similar techniques except for a standard open-tip arterial cannula. Total embolic counts were markedly lower in the new cannula group (20±25 vs 174±378) as were both gaseous (11±15 vs 95±211) and particulate counts (9±11 vs 80±194). CONCLUSIONS: The select 3D cannula design reduces the sandblasting effect of the perfusion jet and, also, may direct emboli from the heart and cardiopulmonary bypass equipment away from the cerebral circulation.

Reduction of myocardial ischemia-reperfusion injury by mechanical tissue resuscitation using sub-atmospheric pressure.

BACKGROUND: Reperfusion-induced injury after myocardial infarction is associated with a well-defined sequence of early and late cardiomyocyte death. Most present attempts to ameliorate this sequence focus on a single facet of the complex process in an attempt to salvage cardiomyocytes. We examined, as proof of concept, the effects of mechanical tissue resuscitation (MTR) with controlled negative pressure on myocardial injury following acute myocardial infarction. METHODS: Anesthetized swine were subjected to 75 minutes of left coronary artery occlusion and three hours of reperfusion. Animals were assigned to one of three groups: (A) untreated control; treatment of involved myocardium for 180 minutes of MTR with (B) -50 mmHg, or (C) -125 mmHg. RESULTS: All three groups were subjected to equivalent ischemic stress. Treatment of the ischemic area with MTR for 180 minutes significantly (p < 0.001) reduced infarct size (area of necrosis/area at risk) in both treatment groups compared to control: 9.3 +/- 1.8% (-50 mmHg) and 11.9 +/- 1.2% (-125 mmHg) versus 26.4 +/- 2.1% (control). Total area of cell death was reduced by 65% with -50 mmHg treatment and 55% in the -125 mmHg group. CONCLUSIONS: Treatment of ischemic myocardium with MTR, for a controlled period of time during reperfusion, successfully reduced the extent of myocardial death after acute myocardial infarction. These data provide evidence that MTR using subatmospheric pressure may be a simple, efficacious, nonpharmacological, mechanical strategy for decreasing cardiomyocyte death following myocardial infarction, which can be delivered in the operating room.

Consensus statement: minimal criteria for reporting the systemic inflammatory response to cardiopulmonary bypass.

The lack of established cause and effect between putative mediators of inflammation and adverse clinical outcomes has been responsible for many failed anti-inflammatory interventions in cardiopulmonary bypass (CPB). Candidate interventions that impress in preclinical trials by suppressing a given inflammation marker might fail at the clinical trial stage because the marker of interest is not linked causally to an adverse outcome. Alternatively, there exist examples in which pharmaceutical agents or other interventions improve clinical outcomes but for which we are uncertain of any antiinflammatory mechanism. The Outcomes consensus panel made 3 recommendations in 2009 for the conduct of clinical trials focused on the systemic inflammatory response. This panel was tasked with updating, as well as simplifying, a previous consensus statement. The present recommendations for investigators are the following: (1) Measure at least 1 inflammation marker, defined in broad terms; (2) measure at least 1clinical end point, drawn from a list of practical yet clinically meaningful end points suggested by the consensus panel; and(3) report a core set of CPB and perfusion criteria that maybe linked to outcomes. Our collective belief is that adhering to these simple consensus recommendations will help define the influence of CPB practice on the systemic inflammatory response, advance our understanding of causal inflammatory mechanisms, and standardize the reporting of research findings in the peer-reviewed literature.

Effects of a waiting period after clopidogrel treatment before performing coronary artery bypass grafting.

STUDY OBJECTIVE: To assess the effects of a waiting period after clopidogrel treatment before coronary artery bypass grafting (CABG). Design. Single-center, prospective, observational study. SETTING: Cardiothoracic surgery intensive care unit at a university-affiliated medical center. PATIENTS: One hundred consecutive patients who received clopidogrel and were scheduled to undergo primary CABG. In 64 of these patients, CABG was delayed at least 5 days after clopidogrel treatment (group A). The other 36 patients received clopidogrel treatment within 5 days of undergoing CABG (group B). MEASUREMENTS AND MAIN RESULTS: Data were collected on patient demographics, time of last clopidogrel dose, preoperative anticoagulant and/or antiplatelet agents administered, surgical characteristics, intraoperative transfusions, blood products transfused, and chest tube output for 24 hours after surgery. No significant differences in baseline characteristics or intraoperative variables (number of bypasses, aortic cross-clamp time, and cardiopulmonary bypass time) were noted between the two groups. Mean +/- SD number of packed red blood cell units/patient was 1.1 +/- 1.4 in group A versus 2.1 +/- 2.5 in group B (p=0.009). Mean +/- SD number of platelet units/patient transfused was 0.5 +/- 0.9 in group A versus 1.9 +/- 1.6 in group B (p<0.001). When comparing a subset of 21 patients who received clopidogrel within 72 hours of surgery with the 64 whose CABG was delayed at least 5 days after clopidogrel treatment, the transfusion rates were significantly higher (95% vs 52%, p<0.05). Specifically, the mean +/- SD number of transfused units/patient of red blood cells (3.1 +/- 2.8 vs 1.1 +/- 1.4, p<0.005) and platelets (2.6 +/- 1.5 vs 0.5 +/- 0.9, p<0.007) was greater in patients who received clopidogrel within 72 hours of surgery. CONCLUSION: A strategy to delay CABG after clopidogrel treatment led to reduced blood product administration. The optimal waiting period after clopidogrel treatment is not known but appears to be at least 5 days before CABG.

The Society of Thoracic Surgeons, The Society of Cardiovascular Anesthesiologists, and The American Society of ExtraCorporeal Technology: Clinical Practice Guidelines-Anticoagulation During Cardiopulmonary Bypass.

Despite more than a half century of "safe" cardiopulmonary bypass (CPB), the evidence base surrounding the conduct of anticoagulation therapy for CPB has not been organized into a succinct guideline. For this and other reasons, there is enormous practice variability relating to the use and dosing of heparin, monitoring heparin anticoagulation, reversal of anticoagulation, and the use of alternative anticoagulants. To address this and other gaps, The Society of Thoracic Surgeons, the Society of Cardiovascular Anesthesiologists, and the American Society of Extracorporeal Technology developed an Evidence Based Workgroup. This was a group of interdisciplinary professionals gathered to summarize the evidence and create practice recommendations for various aspects of CPB. To date, anticoagulation practices in CPB have not been standardized in accordance with the evidence base. This clinical practice guideline was written with the intent to fill the evidence gap and to establish best practices in anticoagulation therapy for CPB using the available evidence. To identify relevant evidence, a systematic review was outlined and literature searches were conducted in PubMed using standardized medical subject heading (MeSH) terms from the National Library of Medicine list of search terms. Search dates were inclusive of January 2000 to December 2015. The search yielded 833 abstracts, which were reviewed by two independent reviewers. Once accepted into the full manuscript review stage, two members of the writing group evaluated each of 286 full papers for inclusion eligibility into the guideline document. Ninety-six manuscripts were included in the final review. In addition, 17 manuscripts published before 2000 were included to provide method, context, or additional supporting evidence for the recommendations as these papers were considered sentinel publications. Members of the writing group wrote and developed recommendations based on review of the articles obtained and achieved more than two thirds agreement on each recommendation. The quality of information for a given recommendation allowed assessment of the level of evidence as recommended by the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Recommendations were written in the three following areas: (1) heparin dosing and monitoring for initiation and maintenance of CPB; (2) heparin contraindications and heparin alternatives; and (3) reversal of anticoagulation during cardiac operations. It is hoped that this guideline will serve as a resource and will stimulate investigators to conduct more research and to expand on the evidence base on the topic of anticoagulation therapy for CPB.

Leiomyosarcoma of the inferior vena cava: surgical management and clinical results.

Leiomyosarcoma of the inferior vena cava (IVC) is a rare lesion with less than 300 cases reported. Optimal management and long-term outcomes are not well described. From August 1984 to June 2004, eight patients with leiomyosarcoma of the IVC were treated at our institution. Clinical and pathologic data, surgical management, and outcomes were assessed. Eight cases were identified (4 males) with a median age of 52 (range 29-66). Presenting symptoms included abdominal pain (n = 5, 63%), lower extremity edema (n = 2, 25%), and palpable mass (n = 2, 25%). Tumor location was between the renal and iliac veins (low) (n = 4, 50%), between the hepatic and renal veins (middle) (n = 3, 38%), and above the hepatic veins with right atrial extension (high) (n = 1, 12%). Two patients with preoperative IVC occlusion were managed with tumor excision and IVC ligation. Three patients had primary repair of the IVC after tumor excision. A polytetrafluorothylene (PTFE) tube graft was used for IVC reconstruction in three cases. There was no postoperative mortality. Postoperative morbidity included deep venous thrombosis (DVT) (n = 1), lower extremity edema (mild n = 1; moderate n = 1), GI bleed (n = 1), and chronic renal insufficiency (n = 1). One patient is currently receiving adjuvant chemotherapy. Four patients received chemotherapy after recurrence, and one received palliative radiation therapy as well. Median survival to this point was 60 months with a median follow-up of 39 months. The 5-year overall survival and disease-free survival was 31 per cent for both (CI 0.1-1.0). The type of IVC reconstruction had no effect on survival (P = 0.22). Recurrence was discovered in four patients (50%) at a median time of 14 months. Resection of leiomyosarcoma of the IVC should be attempted whenever feasible. The management of the IVC can be managed with primary repair, ligation, or prosthetic graft. Long-term survival is possible if complete resection can be achieved.

The Society of Thoracic Surgeons, The Society of Cardiovascular Anesthesiologists, and The American Society of ExtraCorporeal Technology: Clinical Practice Guidelines for Cardiopulmonary Bypass--Temperature Management During Cardiopulmonary Bypass.

In order to improve our understanding of the evidence-based literature supporting temperature management during adult cardiopulmonary bypass, The Society of Thoracic Surgeons, the Society of Cardiovascular Anesthesiology and the American Society of ExtraCorporeal Technology tasked the authors to conduct a review of the peer-reviewed literature, including: 1) optimal site for temperature monitoring, 2) avoidance of hyperthermia, 3) peak cooling temperature gradient and cooling rate, and 4) peak warming temperature gradient and rewarming rate. Authors adopted the American College of Cardiology/American Heart Association method for development clinical practice guidelines, and arrived at the following recommendations: No Recommendation No recommendation for a guideline is provided concerning optimal temperature for weaning from CPB due to insufficient published evidence.

The first successful repair of postinfarction ventricular septal defect: influence of good fortune, team work, and an inquisitive mind.

Research in our institution identified the first case in which cardiopulmonary bypass was utilized. By happenstance, it turned out to be the presumed first repair of postinfarction ventricular septal defect. The circumstances of this interesting case are presented and discussed in the context of our surgical heritage.