RISK STRATIFICATION IN ANAESTHESIA PRACTICE

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1 CHHABRA, Indian J. Anaesth. KIRAN, 2002; MALHOTRA, 46 (5) : BHARADWAJ, THAKUR : RISK STRATIFICATION AND ANAESTHESIA 347 SUMMARY RISK STRATIFICATION IN ANAESTHESIA PRACTICE Dr. B. Chhabra 1 Dr. Shashi Kiran 2 Dr. Naveen Malhotra 3 Dr. Manoj Bharadwaj 4 Dr. Anil Thakur 5 Risk stratification is of vital importance not only in carrying out day to day successful anaesthetic practice but is also essential for development of standard procedure guidelines and/or protocols. Various methods of perioperative risk stratification, along with risks and benefits and limitations are briefly received in this article. Keywords : Anaesthesia risk, Risk stratification. Risk The dictionary meaning of RISK is hazard, danger, exposure to mischance or peril. Risk is a measure of probability (statistical chance) of future occurrence (usually undesirable). No body is with `no risk as a very small but possible chance of untoward outcome exists even for those who do not show presence of a factor known to be associated with undesired outcome. We can grade risk as: Very low risk Low risk Moderate risk High risk Very high risk Risk factors A risk factor is a detectable characteristic or circumstance of individuals or groups which is associated with an increased chance (risk) of experiencing an unwanted outcome. Risk factors can be causes or signals of untoward outcome. They are observable or identifiable before the occurrence of the undesirable event they predict. Dictionary meaning of Stratify Stratify (verb) means arrange in strata; stratum layer or set of layers of any deposited substance; (noun) stratification. Stratification For a trial to be valid, the degree and severity of disease must be accurately characterized in order that all 1. D.A.,M.S., Prof. & Head 2. D.A.,D.N.B.,MD, Lecturer 3. M.D.,D.N.B. Lecturer 4. M.D., Lecturer 5. M.D., Lecturer Department of Anaesthesia and Critical Care Pt. B.D. Sharma P.G.I.M.S., Rohtak Correspond to : Prof. B.Chhabra 4/7-J, Medical Enclave, Rohtak HARYANA, INDIA. groups under study should be as similar as possible to each other thus reducing CONFOUNDING variables. An investigator has available, for study, a specific population of patients, such as the patients treated in a particular hospital or practice. Frequently, it is not practical to study all the individuals available. A sample may be drawn, of representatives, from the large population. This process is called sampling and the extent to which the information obtained may be extrapolated to the total population depends in large measure on the skill with which that sampling was done. Sometimes a process called stratification is used. Stratified samples are drawn to ensure that specified proportions of selected groups are included. Methods used for risk stratification Data Source Relevant studies published are identified using MEDLINE search of the English-language literature, followed by a mannual search of the references of all identified articles. Study collection All clinical studies evaluating methods used for risk stratification. Data extraction The key data extracted from each article includes the inclusion and exclusion criteria of the study patients, the techniques used for testing and the corresponding definitions of positive test results, and the clinical outcomes of the tested patients. Data are analysed using Bayesian conceptual framework, and pretest probabilities are converted to post test probabilities using calculation of likelihood ratios. Study of risk Risk of general anaesthesia is coincident with the risks of surgical operation and the morbid condition that requires this type of therapeutic intervention. In other words, the hazards of anaesthesia are never entirely

2 348 INDIAN JOURNAL OF ANAESTHESIA, OCTOBER 2002 separate (independent) from a second procedure or condition. The study of such risks is very difficult and requires complex multifactorial analysis of large number of patients. Despite these difficulties, such studies are needed to provide objective information on the outcome of anaesthetic and surgical care and to enable accurate prediction of associated risks to be made (Fig.I). Fig. I : Model of measuring anaesthetic outcomes Risk stratification for non-cardiac surgery Although the occurrence of life threatening cardiac complications during and after non cardiac surgery has long been recognized, this problem has gained increasing attention over the past 15 years. In part, this new interest reflects the growing numbers of complex operations in an aging population and increased scrutiny of what were once considered expected events. However, it is also clear that this trend is to a significant extent driven by technology. As methods such as multilead ST segment monitoring and transoesophageal echocardiography have made their way into the recovery areas, there has been a greater appreciation of the association of myocardial ischaemia with adverse cardiac events. 1,2 More importantly, improvements and increased availability of non invasive imaging techniques have made it possible to detect and quantify ischaemia before surgery. Not surprisingly, the occurrence of preoperative, intraoperative and especially postoperative ischaemia has proved to be a predictor or marker of cardiac morbidity and mortality. 1-4 These trends and observations, however, have not clarified either how to best assess perioperative risk or, more importantly, why and when such assessments are necessary. Perioperative cardiac morbidity : the problem Nearly 25 million patients undergo noncardiac surgical procedures each year in the United States. Of these, 1 million are known to have coronary artery disease, another 2-3 million have multiple risk factors, and an additional 4 million are at risk by virtue of being >65 years old. 1 These groups account for approximately 80% of the 1 million patients who suffer perioperative cardiac morbidity and mortality. The 400,000 patients undergoing vascular surgery represent the highest risk group, both because they have a high incidence of coronary disease and because the operative procedures are particularly stressful. Death, nonfatal myocardial infarction, unstable angina pectoris, and congestive heart failure or pulmonary oedema are the most important cardiac complications of noncardiac surgery. Mortality rates from cardiac causes ranges from negligible to 5% or higher for major vascular procedures. 5 Although the incidence of perioperative myocardial infarction is <1% in the general population, it rises to 2-8% in patients with previous myocardial infarction and ranges from 1% to 15% in patients undergoing vascular surgery. Coronary artery disease and/ or significant left ventricular dysfunction are the underlying substrates for most of these complications. 6 Perioperative cardiac risk : How should it be assessed? Because of the magnitude of the problem of perioperative cardiac morbidity, clinicians and investigators have sought to identify patient at greatest risk preoperatively. In this regard, a number of clinical factors have been identified, including (1) Clinical evidence of coronary artery disease from prior myocardial infarction or angina pectoris; (2) Severe left ventricular dysfunction as evidenced by a history of heart failure, a third heart sound, or elevated jugular venous pressure; (3) Factors that increase the likelihood of these conditions such as advanced age, severe hypertension, diabetes mellitus, and arrhythmias; and (4) instability or progression of cardiac disease (e.g. recent myocardial infarction, unstable angina, or refractory heart failure). Several multifactorial indices (Fig.II) have incorporated these markers and have proved quite helpful in identifying patients at high and low risk for non cardiac procedures. 3,4,7-9 However, when the population under evaluation has a high prevalence of coronary artery disease, whether apparent or silent, such as patients undergoing abdominal aorta or peripheral vascular surgery, and even individuals at apparently low risk may have a 5 to 10% incidence of

3 CHHABRA, KIRAN, MALHOTRA, BHARADWAJ, THAKUR : RISK STRATIFICATION AND ANAESTHESIA 349 Fig. II : Use of clinical risk indices to predict postoperative cardiac end points Study Year Patients Type of Quality End Point Pretest n Surgery Rating Probability% Cardiac Risk Index General, Goldman et al orthopedic, Fair Cardiac death, 6 urologic CHF, VT Jeffrey et al Vascular Fair Cardiac death, 11 CHF, VT General, Zeldin vascular, Fair Cardiac death, 3 thoracic CHF, VT Detsky et al Mixed Strong Cardiac death, 10 CHF Unfortunately, there is no convincing evidence that this is the case. There are three potential circumstances under which RISK STRATIFICATION makes sense: (1) If the results would alter the surgical plan, leading either to cancellation of surgery or to an alternative procedure, such as amputation instead of peripheral arterial bypass. (2) If the results indicate a need for coronary revascularization before non cardiac surgery, either by coronary artery bypass grafting or percutaneous transluminal angioplasty; and (3) If the results would alter perioperative management. Each of these potential applications warrants careful scrutiny because even if preoperative testing does lead to these interventions, as is now often the case, are there data to justify these approaches? (Fig.III). Fig. III : Approach to cardiac risk stratification for patients having peripheral vascular surgery Lundquist et al Vascular Fair 17 Cardiac death Lette et al Mixed Weak 10 major Cardiac death Modified Cardiac Risk Index Detsky et al Mixed Strong Cardiac death, 10 CHF Lette et al Mixed Weak 10 major Cardiac death cardiac complications. Therefore, a number of additional diagnostic tests have been evaluated for their potential to further stratify risk. Approaches that have been used are resting and exercise ECG, measurements of left ventricular ejection fraction at rest or with exercise, ambulatory ECG assessments of arrhythmias and ischaemia, exercise and pharmacological stress myocardial scintigraphy, and stress echocardiography. 3,4 Perioperative risk stratification Why or why not? Although experience with approaches of perioperative risk stratification continues to evolve, relatively little thought has been given to the rationale for such assessments. The fiscal impact would increase substantially if more patients at risk were studied or multiple tests were performed. In addition, the results of these tests are likely to lead to additional procedures, morbidity, and mortality. It is possible that these costs and risks are warranted, if they result in improved longterm outcomes for patients undergoing non-cardiac surgery. Perhaps the clearest application of risk stratification is the first of these interventions. However, cancellation of surgery or the selection of a different procedure are decisions that are usually based on clinical factors. Age, co-morbidity and general poor condition and unstable or

4 350 INDIAN JOURNAL OF ANAESTHESIA, OCTOBER 2002 refractory cardiac disease are the usual reasons, rather than the results of additional diagnostic tests. Prophylactic coronary artery vascularization to reduce perioperative cardiac morbidity is the most controversial intervention. The risk of coronary revascularization in these patients is not cited. Those at highest risk for non cardiac surgery are also often at very high risk for coronary artery bypass surgery. Many surgeons would be circumspect in undertaking coronary revascularization in individuals with diffuse vascular disease, poor left ventricular functions, multiple associated diseases and no potential for symptomatic benefit, with the sole goal being to reduce the risk of a subsequent surgical procedure. The third potential application for risk stratification is to use the results to modify perioperative management. Careful intraoperative and postoperative monitoring are standard procedures for those with important clinical risk factors. The ability of additional monitoring by transoesophageal echocardiography or prolonged intensive care unit observation to prevent complications remains unproven. Whether additional risk stratification would lead to safer or more cost-effective perioperative care is a hypothesis that requires testing. 6 Several medical interventions are potentially attractive. These include the use of ß blockers to minimise haemodynamic fluctuations and the effect of excess catecholamines, central sympatholytic agents for much the same objectives, antithrombotic therapy, and other investigational agents that increase myocardial adenosine levels. However, each of these therapies has the potential to increase complications as well as to reduce them. Therefore, the use of these approaches is also not an adequate justification for risk stratification until trials demonstrating their efficacy have been performed. Risks and benefits of perioperative risk stratification If successful, cardiac risk stratification separates patients into various risk categories so that their management can be tailored to their needs. Low risk patients may be spared further testing, and postoperative management may be changed for patients at higher risk. The goal of risk stratification is to reduce overall mortality and morbidity. Clarification of risk status allows the clinician to provide better informed consent. From a societal perspective, reducing perioperative complications and avoiding unnecessary testing could result in substantial cost savings. The major harms of stratification arise from the use of potentially unnecessary preoperative testing and the consequent possibility of ineffective or harmful interventions. Harm may also result from delay of the planned non cardiac surgery. Area of future research Further well-designed studies are needed if we are to determine which non invasive tests can improve risk stratification among intermediate risk patients undergoing non vascular surgery. Study of the optimal stratification strategy should consider not only therapeutic benefit but also the cost-effectiveness of different pathways, given the high prevalence of this problem and the potentially large financial implications of screening numerous patients. Risk stratification for airway assessment Maintenance of a patent patients airway is a primary responsibility of the anaesthesiologists. Interruption of gas exchange, for even a few minutes, can result in catastrophic outcomes such as brain damage or death. Closed claims analysis has found that the vast majority (85%) of airway-related events involve brain damage or death, and as many as one third of death attributable solely to anaesthesia have been related to inability to maintain a patent airway. 10,11 The difficulty of achieving a patent airway varies with anatomic and other individual patient factors, and identification of the patient with a difficult airway is vital in planning anaesthetic management so that endotracheal intubation can be achieved safely. Several clinical criteria can be routinely assessed on patients prior to anaesthesia including mouth opening, Mallampati classification, head/neck movements, ability to prognath, thyromental distance, body weight, and previous history of difficult intubation. Accurate preoperative prediction of potential difficulty with intubation can help reduce the incidence of catastrophic complications by alerting anaesthesia personnel to take additional precautions before beginning anaesthesia and establishing an artificial airway. In addition, more accurate prediction of difficulty with intubation might reduce the frequency of unnecessary maneuvers (e.g. awake intubation) related to false positive predictions. While several studies have evaluated such predictive criteria individually or in arbitrary combinations, there has been no sufficiently powered systematic multivariate analysis of readily available clinical variables in a large general population to determine a method of accurately STRATIFYING the risk of encountering difficulty with intubation. Since reliability of risk stratification using multivariate models requires more than 10 outcomes events per independent variable included in such analyses, this

5 CHHABRA, KIRAN, MALHOTRA, BHARADWAJ, THAKUR : RISK STRATIFICATION AND ANAESTHESIA 351 mandates a study of about 10,000 patients, assuming an estimated frequency of truely difficult intubation of 1%. 12 Recently Arne et al (1998) have given a Clinical predictive index. Its clinical use is easy, as one uses only seven risk factors and the points as shown in the table (Fig.IV). Difficult intubation can be predicted if the score exceeds 11. When a score less than 11 is found, a difficult intubation can be excluded, with a risk of false prediction of 1-2%. 13 Fig. IV: Risk factors retained by the multivariate analysis for predicting difficult tracheal intubation and the corresponding points of the exact and simplified score. The points of simplified score were obtained by multiplying the points of the exact score by 3.15 and then rounding the results to the nearest whole number. Risk factor Point of the simplified score Previous knowledge of difficult intubation No 0 Yes 10 Pathologies associated with difficult intubation No 0 Yes 5 Clinical symptoms of airway pathology No 0 Yes 3 Inter-incisor gap (IG) and mandible luxatum (ML) IG > 5 cm or ML >0 0 IG 3.5-5cm and ML=0 3 IG<3.5 cm and ML<0 13 Thyromental distance >6.5cm 0 < 6.5cm 4 Maximum range of head & neck movement Above About 90 (90 ± 10 ) 2 Below 80 5 Mallampati s modified test Class 1 0 Class 2 2 Class 3 6 Class 4 8 Total ASA physical status scale Preoperative risk assessment Main goals of preoperative assessment are Risk Stratification and potential reduction of the risk by various interventions. Ideally, any method of predicting before operation the subsequent operative and postoperative course of a patient should be applicable to a large number of patients, easy to perform, reproducible and inexpensive. Although there has been considerable effort directed recently into preoperative risk screening, only the ASA grading is applied widely at present. ASA grading The concept of physical status classification was suggested in 1941 by a committee of the American Society of Anesthetists, the predecessor of the American Society of Anaesthesiologists. This Committee had the task of devising a system for collection and tabulation of statistical data in anaesthesia. Although the term operative risk was initially considered, this was deemed unsuitable because it was altered by the magnitude of the surgical procedure. The system was intended to describe the patient, and not the specific anaesthetic or surgical risk. Instead the term physical state was adopted. Initially six categories were described, a seventh being added after the ASA published the classification. In 1961, Dripps et al proposed the current classification. The ASA physical status scale Class I A normally healthy individual Class II A patient with mild systemic disease Class III A patient with severe systemic disease that is not incapacitating Class IV A patient with incapacitating systemic disease that is a constant threat to life Class V A moribund patient who is not expected to survive 24 hour with or without operation. Class E Added to any patient for emergency operation. This classification is now used throughout the world to indicate physical status having become part of the routine shorthand in assessing patients prior to surgery. Virtually all clinical research papers related to aspects of human anaesthesia published in journals of anaesthesia refer to the physical status of the patients under study. The advantage of the ASA physical status classification is its simplicity. The authors of the system intended only to improve communication and hoped to be able to compare results. They clearly stated that this classification was not an estimate to operative risk. Despite this ASA classification has been widely utilized as an index of risk. The reason for this is simple, it is the only expression of the overall pre-operative condition which is widely recorded.

6 352 INDIAN JOURNAL OF ANAESTHESIA, OCTOBER 2002 No other preoperative risk assessment scheme has achieved the same widespread use. Other internationally known patient scoring systems outside the field of anaesthesia include APACHE II, used widely in intensive care, but the need for a 24-h sampling period of 12 routine physiological measurements, age and previous health status underlines the unsuitability of this system for anaesthesia. In contrast, the ASA classification represents a simple estimation of physiological status without the need for clinical resources and can be applied to every patient before operation. The simplicity of the ASA system is its strength. It is also its weakness. Multifactorial risk indices have been developed linking severity of the disease and the operative procedure, in patients with cardiac disease undergoing non cardiac surgery. It is possible that with sufficient effort, a multifactorial index could be devised which considers both the category of operation and to nature of intercurrent disease for a wide range of disorders in the same way that the APACHE II system for intensive care has linked the physiological severity of illness with its nature. Such linkage would result in a more accurate assessment of operative risk. However, the very complexity of such a system would make it unlikely that it would be as widely utilized as the ASA classification. Conclusions Comparisons between institutions are already occurring, and comparisons between individual providers may also become a reality. Inspite of the negative views of such comparisons, they are likely to be mandated because of pressure from health care regulators, insurers, and patients. Despite awareness of the importance of demographic variables and concurrent medical problems in influencing outcome valid comparisons are presently difficult to conduct. Current methods of risk stratification each have limitations. A method for risk assessment based on multivariate analysis from a large group of patients that can be prospectively validated at multiple institutions would be valuable, not only for mortality rate comparisons but also for patient counseling, research and hospital management. Caution must be applied when using risk assessment in individual patients. Physician need to be involved in the development of such severity stratifying systems, since inclusion of inappropriate or medically irrelevant data can influence the outcome of multivariate analysis. Ongoing research and evaluation of scoring systems also need to occur since therapy changes overtime. It is likely that models will need to be developed for application preoperatively, at ICU admission and for the complex, long term patient at 7 days or beyond, in order to fully inform medical decision-making. The potential utility of health status measures needs to be explored in anaesthesia, given the current trend in delivering cost-effective, customer-focused and evidence based practice. References 1. Mangano D, Browner W, Hollenberg M, London M, Tubau J, Tateo I. Association of perioperative myocardial ischaemia with cardiac morbidity and mortality in men undergoing non-cardiac surgery. N Engl J Med 1990; 323: Raby K, Barry J, Creager M, Cook F, Weisberg M, Goldman L. Detection and significance of intraoperative and postoperative myocardial ischemia in peripheral vascular surgery. JAMA 1992; 268: Abraham S, Coles N, Coley C, Strauss H, Boucher C, Eagle K. Coronary risk of non cardiac surgery. Prog Cardiovasc Dis 1991; 34: Wong T, Detsky A. Perioperative cardiac risk assessment of patients for peripheral vascular surgery. Ann Intern Med 1992; 116: Mangano D. Perioperative cardiac morbiidity (review). Anesthesiology 1990; 72: Massie BM, Mangano DT. Risk stratification for non-cardiac surgery. How (and why)?. Editorial comment. Circulation 1993; 87(5): Goldman L. Multifactorial index of cardiac risk in non-cardiac surgery: Ten-year status report (review article). J Cardiothorac Anesthesiol 1987; 1: Eagle K, Coley C, Newell J, et al. Combining clinical and thallium data optimizes preoperative assessment of cardiac risk before major vascular surgery. Ann Intern Med 1989; 110: Hollenberg M. Predictors of postoperative myocardial ischemia in patients undergoing non cardiac surgery. JAMA 1992; 268: Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology 1990; 72: Benumof JL, Scheller MS. The importance of transtracheal jet ventilation in the management of the difficult airway. Anesthesiology 1989; 71: Ganzouri ARE, McCarthy RJ, Tuman KJ, Tanck EN, Ivankovich AD. Preoperative airway assessment: Predictive value of multivariate risk index. Anesth Analg 1996; 82: Arne J, Descoins P, Fusciardi J, et al. Preoperative assessment for difficult intubation in general and ENT surgery: Predictive value of a clinical multivariate risk index. Br J Anaesth 1998; 80:

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