Existential decision-making in a fatal progressive disease: how much do legal and medical frameworks matter?

BACKGROUND: Healthcare legislation in European countries is similar in many respects. Most importantly, the framework of informed consent determines that physicians have the duty to provide detailed information about available therapeutic options and that patients have the right to refuse measures that contradict their personal values. However, when it comes to end-of-life decision-making a number of differences exist in the more specific regulations of individual countries. These differences and how they might nevertheless impact patient's choices will be addressed in the current debate. MAIN TEXT: In this article we show how the legal and medical frameworks of Germany, Poland and Sweden differ with regard to end-of-life decisions for patients with a fatal progressive disease. Taking Amyotrophic Lateral Sclerosis (ALS) as an example, we systematically compare clinical guidelines and healthcare law, pointing out the country-specific differences most relevant for existential decision-making. A fictional case report discusses the implications of these differences for a patient with ALS living in either of the three countries. Patients with ALS in Germany, Poland and Sweden are confronted with a similar spectrum of treatment options. However, the analysis of the normative frameworks shows that the conditions for making existential decisions differ considerably in Germany, Poland and Sweden. Specifically, these differences concern (1) the legal status of advance directives, (2) the conditions under which life-sustaining therapies are started or withheld, and (3) the legal regulations on assisted dying. CONCLUSION: According to the presented data, regulations of terminating life-sustaining treatments and the framework of "informed consent" are quite differently understood and implemented in the legal setting of the three countries. It is possible, and even likely, that these differences in the legal and medical frameworks have a considerable influence on existential decisions of patients with ALS.

Exclusion of older adults from clinical trials in cancer-related pain.

Pain is one of the most common symptoms in cancer patients including older adults. The objective of this study was to evaluate the enrollment criteria that can limit the inclusion of older adults in clinical trials concerning cancer-related pain (CRP). The study included 356 trials registered with ClinicalTrials.gov. Our primary outcome measures were the proportion of trials that excluded patients based on upper age limits (80 years of age or less), strict organ-specific exclusion criteria, broad and imprecise criteria, and inadequate performance score. One hundred and twenty-six trials (35.4%) had upper age limits. Strict exclusion criteria were used in 95 (26.7%) trials. Broad and imprecise exclusion criteria were listed in 57 (16.2%) trials. Low performance score was used as an exclusion criterion in 4 trials (1.1%). Overall, in 241 trials (67.7%) there was either an upper age limit or at least one strict or broad and imprecise exclusion criterion, or a criterion involving the performance status. The odds of excluding older adults were significantly higher in certain neoplasm types, study objectives, intervention types, and center locations. In conclusion, considerable proportion of recent clinical trials concerning CRP either explicitly exclude older adults or create high risk of such exclusion which substantially limits the evidence base for the treatment of such patients in clinical practice. Sponsors and investigators should consider careful modification of the enrollment criteria to improve the inclusion of older individuals who make up the major proportion of cancer patients population.

Echocardiography during the coronavirus disease 2019 pandemic - the impact of the vaccination program. A 2021 update of the expert opinion of the Working Group on Echocardiography of the Polish Cardiac Society.

The coronavirus disease 2019 (COVID-19) pandemic resulted in an urgent need to reorganize the work of echocardiography laboratories in order to ensure the safety of patients and the protection of physicians, technicians, and other staff members. In the previous Expert Opinion of the Working Group on Echocardiography of Polish Cardiac Society we provided recommendations for the echocardiographic services, in order to ensure maximum possible safety and efficiency of imagers facing epidemic threat. Now, with much better knowledge and larger experience in treating COVID-19 patients and with introduction of vaccination programs, we present updated recommendations for performing transthoracic and transesophageal examinations, including information on the potential impact of personnel and the patient vaccination program, and growing numbers of convalescents on performance of echocardiographic laboratories, with the goal of their ultimate reopening.

Palliative care for people living with cardiac disease.

Many cardiovascular diseases lead to heart failure, which is a progressive syndrome causing significant distress and limiting the quality of life, despite optimal cardiologic treatment. It is estimated that about 26 000 people in Poland suffer from advanced heart failure, and this number is growing. That is why palliative care (PC) dedicated to people living with end­stage cardiac diseases should be urgently implemented in Poland. Well­organized PC may not only relieve symptoms and improve quality of life in people living with cardiac diseases not responding to treatment but also support patients and their families during the dying process. Palliative care in patients with cardiac diseases should be continued during the end-of-life period. It should be implemented regardless of prognosis, and adjusted to patients' needs. Two approaches to PC are presented in this expert opinion. The first one (generic) is provided by all medical professionals incorporating PC principles into the usual patient care. The second approach, namely, specialized PC, is ensured by a multiprofessional team or at least a PC specialist who received appropriate training in PC. The model of needs-based (not prognosis-based) implementation of PC is discussed in this paper. Symptom control, support in decision-making, and sensitive, open communication are considered integral elements of PC interventions. Medical professionals developing PC in Poland should think about groups of patients with special needs like those with valvular heart disease, grown­up congenital heart disease, and pulmonary arterial hypertension, as well as elderly people. This consensus document presents main recommendations for future PC organization in Poland. Among others, we suggest changing the Polish National Health Fund reimbursement rules regarding PC and improving cardiologist education on PC.

Cardiac assessment in Wilson's disease patients based on electrocardiography and echocardiography examination.

INTRODUCTION: Wilson's disease (WD) is a rare genetic disorder that leads to impairments in copper metabolism. Patients principally exhibit liver and neuropsychiatric symptoms, but because copper also accumulates in all body organs, other (typically milder) clinical symptoms can occur. To date, cardiac involvement has not been thoroughly investigated in patients with WD. This study aimed to evaluate heart structure and function in patients with WD with commonly available diagnostic methods. MATERIAL AND METHODS: We compared 125 WD patients with an age- and sex-matched control group. Patients with WD were grouped according to their dominant symptoms - neurologic or hepatic. All subjects underwent clinical, electrocardiographic (ECG), and echocardiographic examinations. RESULTS: All subjects had sinus rhythm on electrocardiography. The only ECG parameter that differed between patients with WD and the control group was the QRS prolongation (92.0 vs. 86.4 ms; p < 0.05). On echocardiography patients with WD exhibited more hypertrophy in the left ventricle than controls (posterior wall in diastole: 1.0 vs. 0.93; p < 0.01) and the left ventricle hypertrophy was more pronounced in the neurologic than in the hepatic subgroup (1.05 vs. 0.96 cm; p < 0.01). Left ventricular systolic function was similar in the WD and the control group (ejection fraction: 67.5% vs. 67.7%). On tissue Doppler echocardiography patients with WD demonstrated slowing of myocardial relaxation, which was more evident in the neurologic group. CONCLUSIONS: Heart involvement in WD was manifested mainly by mild left ventricular hypertrophy and subclinical changes in diastolic function, particularly in the patients with the neurologic form of disease.

Perceived work-related stress and early atherosclerotic changes in healthy employees.

OBJECTIVE: This study was conducted to investigate the relationship between perceived work-related stress and preclinical atherosclerosis. METHODS: A total of 100 managers and 50 office workers aged 35-65 participated in a questionnaire study. Individual, family and work-related stress risk factors and coping were evaluated in all the studied individuals. Serum levels of biochemical (total cholesterol, LDL, HDL, TG, glucose) and serological risk factors of atherosclerosis (anticardiolipin, anti-beta(2) GPI, anti-oxLDL, anti-HSP and anti-hsCRP antibodies) were evaluated. A computer analysis of B-mode ultrasound images was used to assess carotid artery intima-media thickness (IMT) and atherosclerotic plaque in carotid arteries. Statistical analysis was conducted with SPSS v. 11.5. RESULTS: The studied individuals showed average ranges of both the global stress level and of coping results. In 71% no changes were found in the ultrasound image and in 29% of individuals (43) the presence of plaque was shown. The mean value of the IMT measure was 0.0618 +/- 0.013 mm. IMT and plaque correlated negatively with the level of global work-related stress (r = -0.26; P < 0.01; and r = -0.28; P < 0.01; respectively). No correlation was found either between work-related stress and coping, or between coping and IMT (P > 0.05), or between work-related stress and healthy lifestyle (no smoking, no excessive use of alcohol, high physical activity), or between healthy lifestyle and IMT (P > 0.05). Positive correlation between IMT and LDL and smoking did not result from higher stress reaction in the studied individuals. CONCLUSIONS: The explanation of the negative correlation between perceived work-related stress and preclinical atherosclerosis was not confirmed either by the subjects under high stress undertaking healthy protective activities or by their escaping into unhealthy behaviour. The most probable interpretation of the results is that in individuals with a low level of perceived work-related stress, somatization of stress takes place.

[Cerebral bleeding as a leading manifestation of infectious endocarditis]. / Udar krwotoczny jako wiodacy objaw infekcyjnego zapalenia wsierdzia.

Infectious endocarditis is frequently complicated with acute cerebral events. In most cases they represent the consequences of cerebral embolism. In the presented case the first clinical manifestation of aortic valve endocarditis was intracerebral bleeding. After exclusion of intracerebral aneurysm the aortic valve was replaced and the further course was uncomplicated.

Femoral rather than carotid artery ultrasound imaging predicts extent and severity of coronary artery disease.

BACKGROUND: Pathological, epidemiological and clinical studies indicate that there is coexistence between peripheral vascular disease and coronary artery disease (CAD). B-mode ultrasound of superficial arteries is a non-invasive, valid and reproducible method of directly visualising and assessing carotid and femoral intima-media thickness (IMT) and focal atherosclerosis. AIM: To evaluate the prognostic importance of carotid and femoral vascular changes in predicting CAD severity. METHODS: 410 patients--300 (73.2%) males and 110 (26.8%) females--aged 29-75 years (mean age 55.9+/-9.5 years), referred for elective coronary arteriography, were studied. Clinical examination and laboratory tests were performed, and ultrasound assessments of IMT and atherosclerotic plaque thickness in the common carotid arteries and common femoral arteries were evaluated. RESULTS: Coronary angiography revealed CAD in 81% of patients (85% of males, 70% of females). Cox multiple hazards regression analyses showed a significant relationship between size of atherosclerotic plaques in peripheral arteries and CAD. Odds ratio of CAD associated with every 1-mm plaque thickening ranged from 1.7 to 3.0 (p <0.001) depending on examined artery. Using multiple stepwise regression analysis, the following parameters were found to be independent predictors of one-vessel CAD: myocardial infarction (MI) in anamnesis (OR=22.3; 95% CI 4.0-122.9), typical chest pain (OR=6.4; 95% CI 1.2-34.2), femoral IMT (OR=5.0; 95% CI 1.4-18.4), ex-smoking (OR=5.6; 95% CI 1.1-28.7), and pulse pressure (OR=1.8; 95% CI 1.0-3.2). Independent predictors of multi-vessel CAD were: MI (OR=3.7; 95% CI 1.8-7.5), typical angina (OR=3.3; 95% CI 1.7-6.5), age (OR=1.05; 95% CI 1.01-1.08), number of cigarettes smoked (OR=0.8; 95% CI 0.6-0.9), total cholesterol level (OR=1.1; 95% CI 1.0-1.2), and left femoral plaque thickness (OR=1.4; 95% CI 1.0-2.0). CONCLUSION: Femoral IMT is an independent predictor of a single-vessel disease, whereas femoral atherosclerotic plaque presence indicates advanced CAD.

Modification of cardiovascular pharmacotherapy in palliative care patients with cancer: a narrative review.

Palliative care patients with cancer are treated with many drugs, especially at the end of life. Limiting polypharmacy decreases the risk of associated adverse effects, medical errors, and harmful drug interactions. The time lag to benefit from the use of many medications used for cardiovascular diseases or their risk factors, such as hypertension and hypercholesterolemia, is frequently longer than the life expectancy of palliative care patients with cancer. It is ethically appropriate to modify, and even to discontinue, cardiovascular pharmacotherapy when there is no prospect of benefit. The decision to discontinue lipid­lowering drugs and antihypertensive drugs is rather straightforward. Antithrombotic therapy may be stopped in low­risk primary prevention but not in high­risk group. Discontinuation of drugs for heart failure may provoke exacerbation of symptoms and should be considered only in the last weeks of life.

Institution of the health care agent in Polish legislation: position of the Polish Working Group on End-of-Life Ethics.

INTRODUCTION In numerous countries legislation has been put in place allowing citizens to appoint persons authorized to make medical decisions on their behalf, should the principal lose such decision­making capacity. OBJECTIVES The paper aimed to prepare a draft proposal of legal regulations introducing into Polish legislation the institution of the health care agent. PATIENTS AND METHODS The draft proposal has been grounded in 6 expertise workshops, in conjunction with several online debates. RESULTS The right to appoint a health care agent should apply to all persons of full legal capacity, and to minors over 16 years of age. Every non-legally incapacitated adult person would be eligible to be appointed a health care agent. Appointment of substitute agents should also be legally provided for. The prerogatives of health care agents would come into effect upon the principals' loss of their decisionmaking capacity, or upon the principals' waiving their right to be provided with pertinent information on their health status. The health care agents would make decisions in all matters pertaining to medical treatment, while remaining under no obligation to perform any hands-on caring duties for their principals. The term of medical power-of-attorney should be discretionary, while its revocation or resignation should be possible at any time. In the event of health care agents' inactivity, or in the event that their actions should appear contrary to the principals' best interests, an attending physician should notify a pertinent court of law whose prerogatives would facilitate revocation of a medical power-of-attorney.  CONCLUSIONS Statutory appointment of a health care agent allows every citizen to appoint in this capacity a person who, to the best of his or her knowledge, would best represent his or her interests in the event that the principal should ultimately lose the capacity to make medical decisions on his or her own behalf.

Plasma neuropeptide Y immunoreactivity influences left ventricular mass in pheochromocytoma.

UNLABELLED: Left ventricular hypertrophy (LVH) in patients with arterial hypertension is closely related to the levels of blood pressure (BP), catecholamines, angiotensin II and other mitogenic peptides. Pheochromocytoma (pheo) is a type of hypertension caused by excessive production of catecholamines. The aim of this study was to determinate if left ventricular hypertrophy in patients with pheochromocytoma is related to catecholamines and neuropeptide Y (NPY). METHODS: 29 patients with pheochromocytoma (22 F, age 40 +/- 13 years), plasma concentration of neuropeptide Y immunoreactivity, noradrenaline (NA), and adrenaline (A) were determined. Twenty-four hour urine collection for determination of noradrenaline and adrenaline were performed. Every patient had echocardiographic examination and 24 h ambulatory blood pressure monitoring. RESULTS: Left ventricular hypertrophy was diagnosed in 14 patients. No differences in systolic and diastolic blood pressure in patients with and without left ventricular hypertrophy were found. Plasma noradrenaline and adrenaline levels did not differ between both groups, while plasma neuropeptide Y immunoreactivity was higher in patients with left ventricular hypertrophy than in patients without left ventricular hypertrophy (18.46 +/- 13.26 vs. 9.3 +/- 5.9 fmol/ml (p = 0.02)). Left ventricular mass index (LVMI) correlated with plasma neuropeptide Y-immunoreactivity (r = 0.42 p = 0.023), however, no relationship between left ventricular mass index and plasma or urine noradrenaline and adrenaline levels were found. CONCLUSION: Our results indicate that mitogenic effect of neuropeptide Y may play a role in pathogenesis of left ventricular hypertrophy in patients with pheochromocytoma.

Practical aspects of new oral anticoagulant use in atrial fibrillation.

Dabigatran, a direct thrombin inhibitor and 2 factor Xa inhibitors, rivaroxaban and apixaban, are target-specific oral anticoagulants (TSOACs) approved for prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (AF). Published data suggest that all 3 agents are at least as efficacious as dose­adjusted warfarin in stroke prevention. Because of their greater specificity, rapid onset of action, and predictable pharmacokinetics, TSOACs have some advantages over vitamin K antagonists, which facilitates their use in clinical practice. The current review addresses the practical questions relating to the use of TSOACs in AF patients based on the available data and personal experience. We discuss topics such as patient selection, renal impairment, drug interactions, switching between anticoagulants, laboratory monitoring, and the risk of bleeding along with its management. We will focus on the aspects of the optimization of treatment with TSOACs in stroke prevention. The understanding of these practical issues by clinicians and patients is of key importance for the safe and effective use of TSOACs in everyday practice.

Simple exercise test score versus cardiac stress test for the prediction of coronary artery disease in patients with type 2 diabetes.

INTRODUCTION: Type 2 diabetes markedly increases the risk of coronary heart disease (CHD), and screening for CHD is suggested by the guidelines. OBJECTIVES: The aim of the study was to compare the diagnostic usefulness of the simple exercise test score, incorporating the clinical data and cardiac stress test results, with the standard stress test in patients with type 2 diabetes. PATIENTS AND METHODS: A total of 62 consecutive patients (aged 65.4 ±8.5 years; 32 men) with type 2 diabetes and clinical symptoms suggesting CHD underwent a stress test followed by coronary angiography. The simple score was calculated for all patients. RESULTS: Significant coronary stenosis was observed in 41 patients (66.1%). Stress test results were positive in 36 patients (58.1%). The mean simple score was high (65.5 ±14.3 points). A positive linear relationship was observed between the score and the prevalence of CHD (R2 = 0.19; P <0.001) as well as its severity (R² = 0.23; P <0.001). The area under the receiver-operating characteristic curve for the simple score was 0.74 (95% confidence interval [CI], 0.62-0.86). At the original cut-off value of 60 points, the score had a similar prognostic value to that of the standard stress test. However, in a multivariate analysis, only the simple score (odds ratio [OR], 1.46; 95% CI, 1.11-1.94; P <0.01 for an increase in the score by 1 point) and male sex (OR, 1.57; 95% CI, 1.24-1.98; P <0.001) remained independent predictors of CHD. CONCLUSIONS: In patients with type 2 diabetes, the simple score correlated with the prevalence and severity of CHD. However, the cut-off value of 60 points was inadequate in the population of diabetic patients with high risk of CHD. The simple score used instead of or together with the stress test was a better predictor of CHD than the stress test alone.

Vitamin K antagonists in anticoagulant therapy of patients with cancer.

Venous thromboembolism (VTE) is a common complication of cancer. Prolonged use of low-molecular-weight heparin in cancer patients provides better VTE prophylaxis compared with vitamin K antagonists. Both therapeutic options have a similar safety profile. If patients on long-term oral anticoagulation are diagnosed with cancer, they should continue treatment with vitamin K antagonists.

Renal function and adaptive changes in patients after radical or partial nephrectomy.

INTRODUCTION: Renal function after renal surgery depends on the volume of renal parenchyma loss and improves in the postoperative period. However, the knowledge on kidney function after radical (RN) and partial (PN) nephrectomy is still insufficient. The aim of this study is to analyze the global renal function and compensatory hyperfunction of the non-operated kidney in patients with renal cancer after RN or PN. METHODS: Fifty-one patients of mean age 62.2 years with renal cancer were included. Thirty-three RN and eighteen PN were performed. We measured creatinine serum concentrations, and we estimated glomerular filtration rate (eGFR) preoperatively and postoperatively at two time intervals: 3 and 12 months after surgery. Additionally, we assessed effective renal plasma flow (ERPF) in dynamic scintigraphy preoperatively and 12 months after surgery. RESULT: At the baseline, all mean measured values were comparable in RN and PN groups (P > 0.05). Three months after surgery, creatinine level increased in both groups, more remarkably in RN group (128 mmol/l vs. 95 mmol/l; P < 0.05), while eGFR diminished (47 ml/min/1.73 m(2) vs. 70 ml/min/1.73 m(2); P < 0.05). Similar biochemical values were observed 12 months after surgery. The mean ERPF of the non-operated kidney 12 months after surgery in RN and PN groups increased by 3.8% (232 ml/min) and 0.1% (200 ml/min), respectively (P > 0.05). The mean ERPF of the operated kidney in PN group decreased by 24.7% (149 ml/min). CONCLUSION: The deterioration of renal function after partial nephrectomy is nearly insignificant clinically. In 1-year postoperative observation, the renal function does not improve. This causes potential compensatory mechanisms to be insufficient.

[Polish guidelines for the prevention and treatment of venous thromboembolism. 2012 update]. / Polskie wytyczne profilaktyki i leczenia zylnej choroby zakrzepowo-zatorowej. Aktualizacja 2012.

The overall objective of the Polish guidelines for the prevention and treatment of venous thromboembolism is to increase patient benefit and safety by appropriate prevention and treatment of deep vein thrombosis and pulmonary embolism as well as proper management of the complications associated with antithrombotic and thrombolytic therapy. These guidelines apply to adult trauma, cancer, surgical, and medical patients as well as those at increased risk of venous thromboembolism. Specific recommendations have been formulated for pregnant women, patients requiring surgery while receiving long-term oral anticoagulant treatment, and patients undergoing regional anesthesia and/or analgesia. We chose to update the existing Polish guidelines with the use of the most recent high-quality international guidelines that we identified and adjusted the final product to Polish cultural and organizational setting. We based our recommendations primarily on the 9th edition of the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines on Antithrombotic Therapy and Prevention of Thrombosis, the European Society of Cardiology Guidelines on the Diagnosis and Management of Acute Pulmonary Embolism, the 3rd edition of the American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines on Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy, the ACOG practice bulletin on thromboembolism in pregnancy (Number 123), and Guidance from the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis on the Duration of Anticoagulant Therapy after a First Episode of Unprovoked Pulmonary Embolus or Deep Vein Thrombosis, as well as two other Polish practice guidelines on the prophylaxis and treatment of venous thromboembolism and the management of patients treated with oral direct inhibitors of factor X or factor II. To make recommendations regarding specific management issues that had not been addressed in other guidelines, or whenever the panel members felt they needed additional information to reach the decision, we also consulted the authors of guidelines developed by other professional societies and organizations as well as additional sources of evidence. For each adapted recommendation, we explicitly assessed its relevance and applicability in the context of the healthcare system in Poland. When necessary, we explicitly stated the rationale for modification of the previously published recommendations and judgements about the values and preferences we assumed. The information regarding reimbursement of drugs mentioned in the recommendations was added in chapters 6-9 and 13 and approved by the National Health Fund. The final version of the practice guidelines was officially approved by the scientific societies and institutions listed at the beginning of the document.