“What’s the Risk?” Assessing and Mitigating Risk in Cardiothoracic Surgery

Abstract

Not everything that counts can be counted, and not everything that can be counted counts.—William Bruce Cameron, Informal Sociology, 1963 To increase awareness and improve safety, quality, and value in cardiothoracic surgery, we provide a synopsis of risk, risk assessment methods, and considerations for mitigating modifiable risks associated in the cardiothoracic surgery patient. Definitions of risk include (1) the possibility or danger of injury or loss; (2) a person or thing that creates a hazard; and (3) the chance of financial loss. One way to quantify risk is to sum the product of consequences and probabilities. A common example of risk, in which the potential outcomes and probability are known, would be the flip of a coin. In surgery, however, quantifying risk becomes much more challenging, and all of the possible outcomes and the exact probabilities of each are difficult to forecast for an individual patient. Risk management involves assessing and mitigating risk through avoidance, modification of risk (eg, altering timing or procedure type, cancellation, modifications in host, and other factors), as well as the acceptance of risk. An effective surgical risk management strategy requires an objective comparison of risk exposure to the anticipated value of an operation for each patient. Fundamental characteristics of risk models include calibration, namely, the level of agreement between observed and expected outcomes, and discrimination, which is the ability to distinguish between high-risk and low-risk patients [1Coulson T.G. Bailey M. Reid C.M. et al.Acute risk change for cardiothoracic admissions to intensive care (ARCTIC index): a new measure of quality in cardiac surgery.J Thorac Cardiovasc Surg. 2014; 148: 3076-3081Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar]. Additionally, surgical risk scoring systems can be static (eg, a snapshot of a patient’s risk before operative intervention) or dynamic—which factor in the unique pathophysiologic changes associated with the planned procedure through defined phases of care with variation of risk over time [1Coulson T.G. Bailey M. Reid C.M. et al.Acute risk change for cardiothoracic admissions to intensive care (ARCTIC index): a new measure of quality in cardiac surgery.J Thorac Cardiovasc Surg. 2014; 148: 3076-3081Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar, 2Gao D. Grunwald G.K. Rumsfeld J.S. Schooley L. MacKenzie T. Shroyer A.L. Time-varying risk factors for long-term mortality after coronary artery bypass graft surgery.Ann Thorac Surg. 2006; 81: 793-799Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar]. The Society of Thoracic Surgeons (STS) Adult Cardiac Database, established in 1989 and utilized by approximately 1,100 participants in the United States, leads other clinical disciplines in risk assessment and transparency of methodology [3The Society of Thoracic Surgeons. Available at http://www.sts.org/quality-research-patient-safety/statistical-methodology-risk-models-and-measures. Accessed August 1, 2016.Google Scholar]. Risk algorithms for adult cardiac surgery have been created, are regularly updated with demographic and clinical data, and are currently available for coronary artery bypass grafting (CABG), cardiac valve surgery, and CABG plus valve surgery. The online STS risk calculator (available at http://riskcalc.sts.org) provides a statistical assessment of the patient’s risk of mortality and postoperative morbidities. Surgeons are strongly encouraged to use the calculated risk profile in assessing an individual patient’s risks and as a starting point for discussing expectations of surgery and informed consent. It should be noted, however, that despite robust standards, data acquisition methods, and validated statistical models, the coding process may complicate reporting [4Hannan E.L. Siu A.L. Kumar D. Racz M. Pryor D.B. Chassin M.R. Assessment of coronary artery bypass graft surgery performance in New York. Is there a bias against taking high-risk patients?.Med Care. 1997; 35: 49-56Crossref PubMed Scopus (57) Google Scholar]. The reporting of outcomes includes a composite rating system and the opportunity for voluntary public reporting (and soon, reports for individual surgeons). The National Quality Forum has developed national voluntary consensus standards for cardiac surgery to foster quality improvement and transparency to promote the highest quality of care for cardiac surgery patients (available at http://www.qualityforum.org). Acquired heart disease affects 27.6 million adults in the United States, is the leading cause of death (611,106 estimated for 2016), and is projected to result in 3.7 million hospitalizations annually [5Centers for Disease Control and Prevention - FastStats. Available at http://www.cdc.gov/nchs/fastats/heart-disease.htm. Accessed August 1, 2016.Google Scholar]. Approximately 600,000 adult cardiac surgical procedures are expected to be performed in 2016 [6Centers for Disease Control and Prevention - FastStats. Available at http://www.cdc.gov/nchs/fastats/inpatient-surgery.htm. Accessed August 1, 2016.Google Scholar]. In addition, congenital heart disease affects approximately 1% of live births (40,000 per year in the United States), and approximately 25% of those require surgery in their first year of life [7Centers for Disease Control and Prevention - FastStats. Available at http://www.cdc.gov/ncbddd/heartdefects/data.html. Accessed August 1, 2016.Google Scholar]. Cancer is the second most common cause of death in the United States, and the American Cancer Society estimates 224,390 new cases of lung cancer in the United States for 2016 [8American Cancer Society - Lung Cancer. Available at http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics. Accessed August 1, 2016.Google Scholar]. Lung cancer causes approximately one in four cancer deaths [9American Cancer Society - Lung Cancer. Available at http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-survival-rates. Accessed August 1, 2016.Google Scholar]. The American Cancer Society also estimates 16,910 new cases esophageal cancer in the United States for 2016. When assessing and categorizing surgical risk, one can utilize a variety of measures such as percentage mortality and relevant statistical information such as standard deviation from the mean, and so forth [10Moonesinghe S.R. Mythen M.G. Grocott M.P. High-risk surgery: epidemiology and outcomes.Anesth Analg. 2011; 112: 891-901Crossref PubMed Scopus (62) Google Scholar]. Risk assessment may include measuring physiologic determinants such as anaerobic threshold, functional capacity and frailty, and serum biomarkers. In addition, surgical risk and indicators of inferior quality correlate with elevated total costs, as shown by the Virginia Cardiac Surgery Quality Initiative and others, reinforcing the incremental costs of complications in CABG [11Osnabrugge R.L. Speir A.M. Head S.J. et al.Costs for surgical aortic valve replacement according to preoperative risk categories.Ann Thorac Surg. 2013; 96: 500-506Abstract Full Text Full Text PDF PubMed Scopus (44) Google Scholar, 12Riordan C.J. Engoren M. Zacharias A. et al.Resource utilization in coronary artery bypass operation: does surgical risk predict cost?.Ann Thorac Surg. 2000; 69: 1092-1097Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar, 13Dimick J.B. Pronovost P.J. Cowan J.A. Lipsett P.A. Complications and costs after high-risk surgery: where should we focus quality improvement initiatives?.J Am Coll Surg. 2003; 196: 671-678Abstract Full Text Full Text PDF PubMed Scopus (140) Google Scholar, 14Speir A.M. Kasirajan V. Barnett S.D. Fonner E. Additive costs of postoperative complications for isolated coronary artery bypass grafting patients in Virginia.Ann Thorac Surg. 2009; 88: 40-45Abstract Full Text Full Text PDF PubMed Scopus (123) Google Scholar]. Importantly, the Centers for Medicare and Medicaid Services has proposed bundled payment models for CABG in which the hospital or health system will accept financial risk for the cost and quality of care during an entire episode of care for as long as 90 days after discharge [15Centers for Medicare & Medicaid Services. Available at https://www.cms.gov/newsroom/mediareleasedatabase/fact-sheets/2016-fact-sheets-items/2016-07-25.html. Accessed August 1, 2016.Google Scholar]. Surgical risk should be assessed and mitigated where possible across all phases of patient care. Risk is increased when a mismatch exists between the physiologic demand of the procedure and the patient’s functional reserve. Age is consistently an important risk factor, and elderly patients incur added risk associated with the potential for frailty, falls, infection, and pulmonary complications [16Stephens R.S. Whitman G.J. Postoperative critical care of the adult cardiac surgical patient. Part I: routine postoperative care.Crit Care Med. 2015; 43: 1477-1497Crossref Scopus (85) Google Scholar, 17Jung P. Pereira M.A. Hiebert B. et al.The impact of frailty on postoperative delirium in cardiac surgery patients.J Thorac Cardiovasc Surg. 2015; 149: 869-875Abstract Full Text Full Text PDF PubMed Scopus (114) Google Scholar]. At the other end of the spectrum, prematurity also confers risk, with one study reporting 43% mortality for surgical corrections using cardiopulmonary bypass [18Dollat C. Vergnat M. Laux D. et al.Critical congenital heart diseases in preterm neonates: is early cardiac surgery quite reasonable?.Pediatr Cardiol. 2015; 36: 1279-1286Crossref Scopus (12) Google Scholar]. Increased body mass index (BMI) in adult patients elevates the risk of wound problems, such as dehiscence and infection, deep venous thrombosis, and prolonged recovery. Surprisingly, moderately overweight cardiac surgery patients have lower operative mortality, reduced hemorrhage and transfusions, and better 5-year survival than patients with a normal BMI [19Parlow J.L. Ahn R. Milne B. Obesity is a risk factor for failure of “fast track” extubation following coronary artery bypass surgery.Can J Anaesth. 2006; 53: 288-294Crossref PubMed Scopus (21) Google Scholar, 20Stamou S.C. Nussbaum M. Stiegel R.M. et al.Effect of body mass index on outcomes after cardiac surgery: is there an obesity paradox?.Ann Thorac Surg. 2011; 91: 42-47Abstract Full Text Full Text PDF PubMed Scopus (144) Google Scholar]. This paradox has also been described for other procedures, such as lung resection surgery [21Paul S. Andrews W. Osakwe N.C. et al.Perioperative outcomes after lung resection in obese patients.Thorac Cardiovasc Surg. 2015; 63: 544-550Google Scholar]. Conversely, lower than normal BMI has consistently been shown to increase surgical risk. Hypothermia is associated with a lower metabolic rate, immunologic changes that increase the risk of surgical site infections, and delays in postoperative recovery and separation from mechanical ventilation. Therefore, measures to maintain normothermia, including control of room temperature, patient draping, warming of intravenous solutions, blood products, ventilator circuits, and blankets, are important components in risk reduction. The STS guidelines on temperature management in patients undergoing cardiopulmonary bypass are readily available [3The Society of Thoracic Surgeons. Available at http://www.sts.org/quality-research-patient-safety/statistical-methodology-risk-models-and-measures. Accessed August 1, 2016.Google Scholar]. Because the risk of stroke with CABG increases with severity of carotid disease, particularly with complete occlusion, a thorough evaluation for cerebrovascular disease is important [22Mickleborough L.L. Walker P.M. Takagi Y. Ohashi M. Ivanov J. Tamariz M. Risk factors for stroke in patients undergoing coronary artery bypass grafting.J Thorac Cardiovasc Surg. 1996; 112: 1250-1258Abstract Full Text Full Text PDF PubMed Scopus (137) Google Scholar]. Additional risk factors for neurologic injury include age more than 60 years, ascending aortic disease, poor left ventricular ejection fraction, and peripheral vascular disease. The use of neuraxial and opioid anesthesia may reduce operative mortality and should be strongly considered in appropriate cases [23Guay J. Choi P. Suresh S. Albert N. Kopp S. Pace N.L. Neuraxial blockade for the prevention of postoperative mortality and major morbidity: an overview of Cochrane systematic reviews.Cochrane Database Syst Rev. 2014 Jan 25; 1: CD010108PubMed Google Scholar]. Chronic respiratory insufficiency can increase operative risk and complicate postoperative care. Prudent pulmonary evaluation should be coupled with smoking cessation at least 30 days before operation in conjunction with patient counseling and, if necessary, nicotine replacement. Smoking cessation within 7 days of surgery increases the risk of pulmonary complications due to airway inflammation and excessive secretions [24Thomsen T. Villebro N. Møller A.M. Interventions for preoperative smoking cessation.Cochrane Database Syst Rev. 2014 Mar 27; 3: CD002294PubMed Google Scholar]. Preoperative pulmonary rehabilitation appears to be beneficial in reducing pulmonary risk [25Bradley A. Marshall A. Stonehewer L. et al.Pulmonary rehabilitation programme for patients undergoing curative lung cancer surgery.Eur J Cardiothorac Surg. 2013; 44: e266-e271Crossref PubMed Scopus (47) Google Scholar]. In thoracic surgery, dependent living correlates with increased surgical risk [26Tsiouris A. Horst H.M. Paone G. Hodari A. Eichenhorn M. Rubinfeld I. Preoperative risk stratification for thoracic surgery using the American College of Surgeons National Surgical Quality Improvement Program data set: functional status predicts morbidity and mortality.J Surg Res. 2012; 177: 1-6Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar]. Modifiable risk factors include weight loss, smoking cessation, and a multidisciplinary approach toward optimizing lung function, including exercise, patient education, and treatment of bronchorrhea and bronchospasm [27Agostini P. Cieslik H. Rathinam S. et al.Postoperative pulmonary complications following thoracic surgery: are there any modifiable risk factors?.Thorax. 2010; 65: 815-818Crossref PubMed Scopus (260) Google Scholar]. Postoperative lung dysfunction is related to mechanical ventilator support, higher inspired oxygen fraction, and intravenous crystalloids, as well as to blood product transfusions [28Blum J.M. Stentz M.J. Dechert R. et al.Preoperative and intraoperative predictors of postoperative acute respiratory distress syndrome in a general surgical population.Anesthesiology. 2013; 118: 19-29Crossref PubMed Scopus (91) Google Scholar]. Early extubation after surgery, particularly for patients with preexisting lung disease, correlates strongly with improved outcomes [29Camp S.L. Stamou S.C. Stiegel R.M. et al.Quality improvement program increases early tracheal extubation rate and decreases pulmonary complications and resource utilization after cardiac surgery.J Card Surg. 2009; 24: 414-423Crossref PubMed Scopus (43) Google Scholar]. The STS provides education on avoiding prolonged ventilation through its webinar series [3The Society of Thoracic Surgeons. Available at http://www.sts.org/quality-research-patient-safety/statistical-methodology-risk-models-and-measures. Accessed August 1, 2016.Google Scholar]. Preoperative evaluation should also include assessing the risk of myocardial ischemia, ventricular dysfunction, rhythm abnormalities, and pulmonary hypertension during the perioperative period. The right ventricular failure risk score is a simple and useful clinical tool to quantify the risk of postoperative right ventricular dysfunction in left ventricular assist device candidates. An elevated right ventricular failure risk score can suggest a need for postoperative inhaled nitric oxide, inotropic support, and mechanical support of the right side of the heart [30Matthews J.C. Koelling T.M. Pagani F.D. Aaronson K.D. The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates.J Am Coll Cardiol. 2008; 51: 2163-2172Abstract Full Text Full Text PDF PubMed Scopus (560) Google Scholar]. Furthermore, nutritional status, weight loss, skeletal myoatrophy, and peripheral edema need to be fully evaluated. Nutritional support should be strongly considered for at-risk patients whenever feasible. Liver dysfunction can confer considerable risk as it is associated with coagulopathy and hemorrhage, sepsis, cardiomyopathy with both systolic and diastolic dysfunction, peripheral vasodilation, and pulmonary and renal dysfunction [31Lopez-Delgado J.C. Esteve F. Javierre C. et al.Influence of cirrhosis in cardiac surgery outcomes.World J Hepatol. 2015; 7: 753-760Crossref PubMed Scopus (28) Google Scholar]. The Model for End-Stage Liver Disease (MELD) categorizes patients by bilirubin, creatinine, international normalized ratio, and etiology of the underlying liver dysfunction [32Kamath P.S. Kim W.R. for the Advanced Liver Disease Study GroupThe model for end-stage liver disease (MELD).Hepatology. 2007; 45: 797-805Crossref PubMed Scopus (1130) Google Scholar, 33Thielmann M. 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The incidence of bleeding complications from acquired coagulopathy is increasing with the introduction of various newer anticoagulants for treating atrial fibrillation and coronary and cerebrovascular disease, as well as the use of nontraditional medical remedies [46UpToDate. Available at http://www.uptodate.com/contents/preoperative-assessment-of-hemostasis. Accessed August 1, 2016.Google Scholar, 47UpToDate. Available at http://www.uptodate.com/contents/approach-to-the-adult-patient-with-a-bleeding-diathesis. Accessed August 1, 2016.Google Scholar]. The surgical team must be familiar with the effects of common drugs that may alter coagulation, including their pharmacokinetics as well as bridging and reversal strategies. The HAS-BLED (acronym for hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) bleeding risk score is useful, and includes age, liver dysfunction, renal dysfunction, bleeding tendency, warfarin and antiplatelet drug use, and alcohol excess [48UpToDate. Available at http://www.uptodate.com/contents/anticoagulation-in-older-adults#H10666069. Accessed August 1, 2016.Google Scholar]. The STS has created a valuable review of antiplatelet agents for cardiac and noncardiac operations [3The Society of Thoracic Surgeons. Available at http://www.sts.org/quality-research-patient-safety/statistical-methodology-risk-models-and-measures. Accessed August 1, 2016.Google Scholar]. Hospital-acquired infections are common and costly [49Lobdell K.W. Stamou S. Sanchez J.A. Hospital-acquired infections.Surg Clin North Am. 2012; 92: 65-77Abstract Full Text Full Text PDF Scopus (42) Google Scholar]. Risk factors include age, being female, increased BMI, and having comorbidities. Inherited and acquired immune deficiencies must be considered and managed during the perioperative period and beyond. Many options exist for skin antisepsis, draping, and wound closure. The role of rigid sternal fixation hardware rather than sternal wires to prevent dehiscence and infection remains undefined. Negative pressure wound therapy has simplified and improved the management of open and infected wounds [50Simek M. Hajek R. Fluger I. et al.Superiority of topical negative pressure over closed irrigation therapy of deep sternal wound infection in cardiac surgery.J Cardiovasc Surg (Torino). 2012; 53: 113-120PubMed Google Scholar, 51Steingrimsson S. Gottfredsson M. Gudmundsdottir I. Sjögren J. Gudbjartsson T. 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