Abstract
For the past nearly four decades, performance of catheter-based cardiovascular interventions has been considered largely inaccessible to formal scrutiny. It has been assumed that interventional knowledge and skills are based on empiricism and can be transferred only tacitly. In addition, over the past decades, the importance of clinical trials based evidence and charms of instrumentation technology have been strongly overemphasized with these factors contributing to the demise of the importance of cognitive skills and decline of technical abilities of the operators, both required for the procedural interventional expertise. In this chapter, the key importance of cognitive skills for interventional expertise has been emphasized. Development of training curricula and clinical practice based on deliberate practice and acquisition of relevant cognitive skills is needed to raise the level of professional standards and to improve the quality of interventional services in the best interest of all stakeholders, of which our patients are the most important.
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Notes
- 1.
The actual increase in options is more than expressed by the exponential equation because the number of initial options increases. For example, to increase support second guide-wire, to increase back up of different guiding-catheter, etc., can be considered.
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Appendixes
Appendixes
10.1.1 Appendix A – Risk Accounting in Industry: An Example
Lacking comprehensive risk control concepts in health care, the structure of a risk control program published by the Center for Chemical Process Safety (CCPS) [56] supplemented by nomenclature from aviation industry [57] shall be briefly reviewed.
Establishment of risk control programs starts with descriptive and standardized terminology of relevant hazard themes (Table 10.5). The subsequently developed safety management system (SMS) details methods to identify, analyze, and control all relevant hazards inherent to the enterprise; tracks risk mitigation efforts; and provides means to detect yet unexplored emerging hazards. SMS entails four components: safety policy, safety management, safety assurance, and safety promotion; each dedicated to subtasks designed to meet the overall safety goals. CCPS has outlined safety elements under four major headings:
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Commitment to process safety containing process safety culture and competency, compliance with standards, workforce involvement, and stakeholder outreach
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Understanding hazards involved in the enterprise
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Risk management including operating procedures, safe work practices, integrity and reliability assets, training and assurance of performance, conduct of operations, and emergency management
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Learning from experience based on incident investigation, measurement and metrics, auditing, management review, and continuous improvement
Analysis of hazards involved in a specific process typically starts with asking questions such as “What can (what did) go wrong?” “What are the consequences?” “How likely is it to happen?” “How do consequences and frequency combine?” “Is the current level of risk tolerable, considering the existing safeguards? If not, what needs to be done to reduce and manage the risk?” Efficiency of the analytical process preferably conducted in what-if-brainstorming sessions must be assured by involving experts intimately familiar with that processes. The benefits of expert-based rational risk management cited by CCPS include:
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Logical way to analyze risk
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Confidence that risk management decisions are rationally determined and not arbitrarily made
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Greater consistency in risk-based decision-making across the organization
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Provision of basis for prioritizing/apportioning finite resources
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Provision of protection of organization’s permission to operate
Addressing the issue of uncertainty, CCPS acknowledges limitations of the current mathematical models of physical reality to predict events and to account for all relevant risks and risk factors. It pledges for continuous refinements of models based on rational data analysis.
In proactive safety management programs, the estimates of the likelihood of incidents are based on review of historical records of similar events (retroactive analysis), design of fault and event tree diagrams, and analysis of common cause failures and factors concerning human reliability. Comprehensive analysis of all relevant individual and societal risk factors involved in a given operation should inform the stakeholders about the rates of equipment failures and possibilities and types of human errors. It also should adequately instruct decision makers to issue guidelines and employ other necessary risk control measures.
10.1.2 Appendix B – Risk Accounting in Medicine: Initial Attempts
Risk accounting in medicine has a long and distinguished tradition punctuated by some heroic battles and characterized by recent deficits.
The dictum “first, does no harm” (primum non nocere) based on a statement in the Hippocratic Corpus Volume VII: Epidemics (∼ fourth century B.C.) sums the guiding principle of risk accounting in medicine ever since. The actions of physicians should be always guided by careful weighing of the risks against the expected benefits in the best interest of their patients. An example of violation of this principle provide writings by Ignaz Philipp Semmelweis [58].
In considering the risk accounting in medicine, three fundamental aspects are important: first, the physician acts on behalf of the patient who carries the potential harm alone; second, the knowledge of risk is highly asymmetrical between the two parties; third, the risk at stake—health—is considered the highest of man’s goods.
Risk accounting in medicine appears particularly difficult due to the large number of known and unknown dynamic variables involved. Consider, for example, the risk assessment of chemotherapy in a patient with leukemia with poorly defined status of the remaining stem cells, tumor cell burden, and presence of associated diseases that is professionally exposed to X-ray radiation. No formula can assess the risk of treatment of the standard or modified course of treatment.
Formally, based on risk and benefit considerations, four basic categories of treatment outcomes can be distinguished (Table 10.6); however, in clinical practice, transitions between treatment outcomes are far more complex and fluent. The first step of risk control in medicine is risk awareness, closely followed by risk prevention. In a bold move in 1999, the Institute of Medicine, Washington, DC, has launched a major initiative to improve patients’ safety in health care [59]. Their main focus was to standardize terminology (Table 10.7), to promote safe practices, and to assure transparency in handling of errors in health care. In their introduction, the authors remarkably stated:
Yet silence surrounds this issue (of errors). For the most part, consumers believe they are protected. Media coverage has been limited to reporting anecdotal cases. Licensure and accreditation confer, in the eyes of the public, a “Good Housekeeping Seal of Approval”. …. Yet, licensing and accreditation process have focused only limited attention on the issue, even these minimal efforts have confronted some resistance from health care organizations and providers. ….. The goal of this report is to break this cycle of inaction….. The focus must shift from blaming individuals for past errors to a focus on prevention future errors by designing safety into the system….. Health care is a decade or more behind other high-risk industries in its attention to ensuring basic safety.
Have their goals been met? Recent report based on evaluation of risk control measures evaluated in selected participating hospitals 10 years after launching the initiative says no [60]; not much has changed. A similar initiative has been launched by the World Health Organization (WHO) [61]. The main focus of this initiative has been to standardize terminology of errors (Table 10.8) and to propose guidelines for their control. The impact of this initiative in medical communities has not yet been established.
10.1.3 Appendix C (Table 10.9–10.14)
10.1.4 Appendix D (Based on Ref. [72])
10.1.4.1 Latent Risk: Patient Factors
The latent risk associated with CBCVI is partly related to the patients’ overall state of health, emphasizing specific organ functions, presence of diabetes, allergic disposition, old age fragility, and panvascular status.
10.1.4.1.1 Heart Function and Coronary Status
Impaired left ventricular (LV) function, particularly if associated with the right ventricular (RV) dysfunction, increases the latent risk of CBCVI, particularly in cardiac interventions. The latent risk is proportional to the severity of dysfunction. Based on the echocardiography measurements of the left ventricular ejection fraction (LVEF), mild, LVEF > 45%, moderate, LVEF >30%, and severe, LVEF < 30%, reduction of the systolic left ventricular function can be distinguished. In patients with a chronic but stable mild-to-moderate impairment, adequate avoidance of volume overload and hypertension usually suffice to control the heart failure. In patients, with acute cardiac failure or severe chronic ventricular dysfunction, additional pharmacological or mechanical support might be required.
In jeopardy score, the impact of the LV dysfunction on procedural risk has been defined; one point has been assigned for each myocardial segment supplied by the target vessel or by vessels with a diameter stenosis ≥70% and half-point was assigned to myocardial segments that were hypokinetic and were not supplied by a vessel with a significant stenosis. Jeopardy score calculation is based on a simplified AHA/ACC coronary segment classification (Table 10.15).
Patients with high jeopardy scores and patients with target vessels supplying the majority of viable myocardium, ejection fraction < 20-30% or patients with cardiogenic shock or critical multiple vessel coronary artery disease have been considered candidates for supported PCI. Besides the severity, the cause and the duration of the LV dysfunction should also be considered. Acutely ischemic myocardium lacking the protective collateral vascularization appears to represent a greater risk compared to similar LV dysfunction due to established ischemia.
10.1.4.1.2 Renal Function
Cardiovascular interventions guided by X-ray angiography and fluoroscopy are associated with contrast agent exposure ranging from 50 up to 500 ml/procedure (main range 70–200 ml/procedure), depending on the kind of the intervention. X-ray contrast agents are not metabolized and are excreted exclusively via the kidney in a chemically unchanged state. Their administration is one of the most common causes of progression of renal dysfunction in patients with chronic kidney disease along with other states such as volume depletion, use of specific antibiotics (e.g., aminoglycosides), nonsteroidal anti-inflammatory agents, angiotensin-converting-enzyme inhibitors, cyclosporin, and urinary tract obstructions.
It is important to realize that in healthy individuals, the renal excretory function decreases with age (Table 10.16).
To reduce the risk of procedure-related deterioration of the renal function or occurrence of renal failure, the interventionalists should know the baseline renal function or the stage of the chronic renal disease, if present. Stages of chronic kidney disease are based on functional impairment determined by glomerular filtration rate: chronic kidney disease is defined either as kidney damage or GFR < 60 ml/min/1.73 m2 for ≥3 months. Kidney damage is defined as pathologic abnormalities or markers of damage, including abnormalities in blood or urine tests or imaging studies (From Ref. [73]) (Table 10.17, 10.18).
Contrast-induced nephropathy (CIN) has been defined as ≥25% increase in serum creatinine from baseline or absolute increase by 44.2 μmol/l (0.5 mg/dl) within 48 h after application of a contrast agent lasting for a minimum of 2 days. Patients at risk for developing CIN include those with preexisting renal disease, type II diabetes regardless of age, elderly, aged, and dehydrated patients, patients on nephrotoxic medication, and those with a prolonged hypotension, high contrast media exposure, (>200 ml), repeated contrast media exposures, or those with application of high osmolarity agents. Measures to prevent are reviewed in Table 10.19:
To mitigate risk of CIN in patients with high risk, the admission rules include:
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Hospitalization 2 days prior to PCI
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Adequate hydration and judicious use of diuretics!
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Staging diagnostic coronary angiography and PCI by >10 days
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Avoiding other procedures requiring contrast agents
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Using biplane angiography, if available
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Consideration of preventive hemodialysis in high-risk patients with high contrast exposure.
In patients developing CIN despite preventive measures, the severity and progression of renal dysfunction must be closely monitored. Management of patients with established CIN includes:
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Transfer to intensive care unit where acute hemodialysis is available
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Close monitoring of input and output
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Daily determination of creatinine, urea, and electrolytes for 5 days as needed
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Consultations with nephrologists as needed
Installing the preventive measures shall reduce the incidence of CIN in a vast majority of patients including in those with stage IV chronic renal failure. In patients with chronic renal insufficiency, besides considering the risk of CIN, the high incidence of extensive vascular calcifications requires consideration in planning the intervention Table 10.20.
10.1.4.1.3 Patients with Thyroid Disease
Application of iodinated contrast agents during CBCVI is associated with a high iodine exposure. However, although ∼15–100 g of iodine, corresponding to 1,500–10,000-fold amount of total iodine content of the human body, is applied, only a fraction of this amount, approximately 0.1–0.001‰ (0.5–36 ig/ml), is biologically active-free inorganic iodine. In addition, some free iodine is generated by deiodination of the organically bound iodine (∼0.1–0.2‰ of the total administered dose within 1 h of exposure). The free iodine may, however, induce thyrotoxicosis in susceptible patients such as those with hyperthyroid disease, immunologically based thyroid disease, autonomic thyroid tissue, multinodular goiter in individuals living in endemic iodide-deficient regions, and in patients receiving certain medications (e.g., amiodarone, expectorans) or those having particular nutritional habits (e.g., kelp ingestion).
Iodide-induced thyrotoxicosis (IIT) is frequently associated with sustained adverse cardiovascular effects including cardiac arrhythmias, conduction abnormalities, and heart failure. Life-threatening symptoms of persistent heart failure and threatening arrhythmias may occur in compromised patients. To reduce the risk of IIT, screening is required prior to CBCVI. The checklist typically includes the assessment of the history of thyroid disease, exclusion of offensive medication, palpation of the thyroid gland, and laboratory examinations (thyroid stimulating hormone (TSH)) assay is performed; if suppressed (decreased), free triiodothyronine (T3) and, less frequently, free tetraiodothyronine (fT4) are measured.
Preventive measures prior to CBCVI are recommended in patients at risk for IIT. Extended drug treatment is mandatory in patients at risk, and in those with overt thyrotoxicosis scheduled for emergency, CBCVI are reviewed in the Table 10.21.
In stable patients with overt hyperthyroidosis, CBCVI should be deferred until the thyroid function has been normalized. The attendance to the precautionary measures and preventive treatments has markedly reduced the incidence of ITT to the point when it has become a rarity.
10.1.4.1.4 Diabetes Mellitus
Presence of diabetes and diabetic angiopathy is associated with greater latent risk and poorer outcome of CBCVI. For example, in patients with a clinically relevant coronary artery disease (CAD), the incidence of the left main lesions and multivessel, diffuse disease, large plaque burden, and poor collateralization is significantly higher compared to the nondiabetic patients with CAD. Despite the marked improvements in interventional treatments and significant reduction of procedure-related complications, the incidence of clinical endpoints such as short-term and long-term mortality, target lesion and target vessel revascularization, thrombotic occlusion, and restenosis has remained significantly higher in diabetics compared to nondiabetics in both elective and emergency settings.
To reduce the latent risk related to the altered metabolic state and differences in diabetic angiopathy in diabetic patients undergoing CBCVI, a number of diabetes-specific issues and patient-related factors need to be considered, including greater underestimation of the severity and extent of the vascular, but particularly the CAD compared to nondiabetics, greater likelihood of vascular and organ multi-morbidity, metabolic instability, greater likelihood of contrast agent-induced nephropathy, greater potential of side effects from medications, especially biguanides, and greater likelihood of immune incompetence and infection. To avoid metabolic complications, tight metabolic control and adjustments in medication, if required, are reviewed in the Table 10.22.
In addition to the metabolic state of the diabetic patients, the peculiarities of the diabetic vasculopathy need to be considered. Long lesions, diffuse character of the disease, and greater propensity for extensive calcifications should be accounted in designing the strategy and in performing the interventions. Plaque modification, selection of particular non-traumatizing instrumentation, long stents, etc., are some of the measures potentially applicable.
10.1.4.1.5 Allergy
The increase in the latent risk in patients with known allergies or allergic predisposition is relatively low. Adverse responses to iodine contrast agents (ICA) occur in ∼5–10% of patients undergoing CBCVI with very mild reactions occurring in the majority of cases. Moderate-to-severe adverse responses have been estimated at 1–2‰ and fatalities at ∼0.001‰ (0.0003–0.0026‰) of ICA applications. The use of nonionic low-osmolality contrast agents has been considered safer and represents the current choice in the majority of patients. Allergy-like and true allergy responses are possibly more common in patients with a history of asthma and allergies to medications, food, and metals. In predisposed patients, the symptoms are not only more frequent but tend to be also more severe.
Although the exact mechanism of adverse responses to ICA has not been elucidated in the literature, non-anaphylactoid (chemotoxic, vasovagal, and idiopathic) and anaphylactoid (idiosyncratic “allergy-like” and true allergic) responses are distinguished. Non-anaphylactoid chemotoxic responses may be dose dependent and include primarily nephrotoxic and neurotoxic, as well as some cardiovascular effects (e.g., arrhythmogenicity). Anaphylactoid responses may be nonspecific reactions due to as yet unknown mediators, or they may be mediated by antibodies (IgE) or T-lymphocytes. Nearly all severe responses occur within minutes (≤20 min) following ICA exposure. In rare cases, late responses (up to 7 and more days), consisting usually of mild urticaria, bronchospasm, or renal dysfunction, have been reported.
Prophylactic medication is recommended for all predisposed patients and for those with previous adverse responses to ICA. The suggested oral regimen consists of:
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Prednisone 50 mg p.o., 12, 6, and 1 h prior to exposure
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Diphenhydramine, H1-antihistamine, 50 mg p.o., 12 and 1 h prior to exposure
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Ranitidine, H2-histamine receptor blocker, 50 mg p.o., 1 h prior to exposure
An intravenous regimen can alternatively be given in patients unable to take oral medication.
In patients experiencing allergy-like responses following the exposure to ICA, the treatment depends on the type and the severity of symptoms. The majority of responses are grade 1, very mild symptoms, consisting of urticaria, pruritus, and diaphoresis without systemic symptoms. Grade 2 is associated with mild-to-moderate dyspnea due to laryngeal edema and bronchospasm, hypotension due to vasodilatation, and abdominal symptoms (nausea, vomiting, abdominal pain). In grade 3, moderate-to-severe dyspnea and profound hypotension occur. Grade 4 refers to severe cardiocirculatory and pulmonary compromise and/or arrest Table 10.23.
It is important to achieve the full relief of symptoms and to restore a stable cardiocirculatory and pulmonary function prior to resuming the intervention.
10.1.4.1.6 Fragile Patients
The majority of patients undergoing CBCVI are 60–80 years old, yet the proportion of the aged (>80 years) is increasing. Fragility and advanced age have been acknowledged as markers for a more advanced and more severe vascular disease and higher incidence of comorbidities.
In patients with no overt or active disease, the estimation of frailty accounting for factors such as general health status, medication intake, nutritional state, weight, mobility, coordination, strength, self-sufficiency, cognition, affectivity, and social interaction based on metrics such as frailty index [75] may be useful to determine the appropriateness of CBCVI and considerations regarding surgery. In high-risk interventions, life quality gained and life expectations should be also considered.
In patients suffering from a relevant or limiting nonvascular and/or concomitant vascular disease, the latent risk may exceed the expected benefits, and thorough weighting of pros and cons of CBCVI is required. If CBCVI has been indicated, special precautions are required including implementations of the least traumatic therapy option, short procedure time, close post-procedural monitoring, and early hospital discharge. Following CBCVI, polypharmacy should be avoided. When prescribing anticoagulants and antithrombotic agents, the increased risk of bleeding should be considered.
10.1.4.1.7 Panvascular Patients
Panvascular disease has been defined as clinically significant vascular disease in at least two major vascular territories. The major risk factors for panvascular state are type II diabetes regardless of age and the age <75 years [76]. In panvascular patients, likely both the latent and the actional risk are increased. To mitigate the actional risk, the operator should take into account the entire vascular morbidity of the patient; in addition to the standard protocols, the relevance of the disease of all involved vascular beds must be evaluated often requiring interdisciplinary expertise. If several procedures are required, their order is based on urgency and cumulative procedural risk. Frequently, in patients with clinically relevant CAD, the coronary interventions are performed first. However, simultaneous interventions in two different vascular territories and hybrid procedures in the same or different vascular beds may also represent valid options (Ref. [77]).
10.1.4.1.8 Critically and Terminally Ill Patients
Critically and terminally ill patients with an assumed life expectancy ≤6 months are eligible for palliative CBCVI in all emergency cases. In these patients, both the latent and the actional risk are likely increased. Although, palliative interventions are always indicated, futile interventions are not. The indications for elective procedures in critically and terminally ill patients are based on the assessment of the actional risk-to-expected-benefit ratio. In these patients, the gain in quality of life represents the lead target of the intervention. However, in all cases, the wish of the patient and ethical considerations shall override the assessed ratios.
10.1.4.2 Lesion Factors
Lesion factors relevant to risk can be broadly divided into those associated with the vasculature, proximal to the target site, and those associated with the target site.
10.1.4.2.1 Access Vasculature
The vessels between the access site and the target site may be hostile to catheter-based cardiovascular interventions due to elongation, excessive tortuosity, anomalies, aneurysms, high plaque burden, multiplicity of lesions, etc. Although the presence of a single or several of these factors may remain clinically silent and latent risk neutral, the actional risk may go up, depending on the degree of traumatization. The puncture of highly calcified vessels, the use of larger or longer sheaths, the deployment of stiff guide-wires or extra long guides increase actional risk due to the increased incidence of bleedings, vessel wall injury, or even perforation. The presence of diffuse disease, multiple plaques, and high calcification of the access vasculature increases the risk destabilization of silent plaques, distal embolization, dissections, or other types of traumatization. The magnitude of the added actional risk due to the presence of these factors relates to severity of these changes on one hand and the facility of the technique employed. Highly skilled approach may significantly reduce or even eliminate the added actional risk with the less-skilled approach causing just the opposite.
10.1.4.2.2 Target Site
The hostile target sites are those associated with increased actional risk in proportion to their complexity. Depending on morphological findings, the increase in risk can be additive, multiplicative, or even exponential. Target site morphologies associated with increased actional risk have been reviewed elsewhere [64]. The operator’s actions may mitigate or aggravate the expected actional risk.
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Lanzer, P. (2013). Cognitive and Decision-Making Skills in Catheter-Based Cardiovascular Interventions. In: Lanzer, P. (eds) Catheter-Based Cardiovascular Interventions. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-27676-7_10
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