Ten Questions and Some Reflections about Palliative Care in Advanced Heart Failure Patients.

Heart failure is a clinical syndrome with increasing prevalence, high morbidity and mortality. It is characterized by high symptom burden, poor quality of life and high economic costs. This implies that the heart failure (HF) patients who receive palliative care (PC) have needs similar to cancer patients, but which are often unmet. This paper analyzes the main unresolved issues regarding the relationship between HF patients and the referral to an early PC program. These issues are presented as ten questions related to which patients should be admitted to PC and at what stage of their disease. Furthermore, the barriers opposing to referral to PC, the role of cardiologists and PC physicians within the care team, the gap between the scientific societies' suggestions and the real world, the right time to promote patients' awareness and shared decision making, regarding prognosis, end of life wishes and choices, with reference also to cardiac implantable devices' deactivation, are discussed. These unresolved questions support the need to reevaluate programs and specific models in achieving equal access to palliative care interventions for HF patients, which is still mainly offered to patients with cancer.

Palliative Care for Patients with End-Stage, Non-Oncologic Diseases-A Retrospective Study in Three Public Palliative Care Departments in Northern Italy.

Patients with irreversible malignant and non-malignant diseases have comparable mortality rates, symptom burdens, and quality of life issues; however, non-cancer patients seldom receive palliative care (PC) or receive it late in their disease trajectory. To explore the characteristics of non-cancer patients receiving PC in northern Italy, as well as the features and outcomes of their care, we retrospectively analyzed the charts of all non-cancer patients initiating PC regimens during 2019 in three publicly funded PC departments in Italy's populous Lombardy region. We recorded the baseline variables (including data collected with the NECPAL CCOMS-ICO-derived questionnaire used since 2018 to evaluate all admissions to the region's PC network), as well as treatment features (setting and duration) and outcomes (including time and setting of death). Of the 2043 patients admitted in 2019, only 12% (243 patients­131 females; mean age 83.5 years) had non-oncological primary diagnoses (mainly dementia [n = 78], heart disease [n = 55], and lung disease [n = 30]). All 243 had Karnofsky performance statuses ≤ 40% (10−20% in 64%); most (82%) were malnourished, 92% had ≥2 comorbidities, and 61% reported 2−3 severe symptoms (pain, dyspnea, and fatigue). Fifteen withdrew or were discharged from the study PCN; the other 228 remained in the PCN and died in hospice (n = 133), at home (n = 9), or after family-requested transfer to an emergency department (n = 1). Most deaths (172/228, 75%) occurred <3 weeks after PC initiation. These findings indicate that the PCN network we studied cares for few patients with life-limiting non-malignant diseases. Those admitted have advanced-stage illness, heavy symptom burdens, low performance statuses, and poor survival. Additional efforts are needed to improve PCN accessibility for non-cancer patients.

[ANMCO Position paper: Care pathway for advanced heart failure patients candidate for heart transplantation/ventricular assist device]. / Position paper ANMCO: Percorso assistenziale del paziente con insufficienza cardiaca avanzata candidabile a trapianto/assistenza ventricolare meccanica.

Heart failure is a complex clinical syndrome with a severe prognosis, despite therapeutic progress. The management of the advanced stages of the syndrome is particularly complex in patients who are referred to palliative care as well as in those who are candidates for cardiac replacement therapy. For the latter group, a prompt recognition of the transition to the advanced stage as well as an early referral to the centers for cardiac replacement therapy are essential elements to ensure that patients follow the most appropriate diagnostic-therapeutic pathway. The aim of this document is to focus on the main diagnostic and therapeutic aspects related to the advanced stages of heart failure and, in particular, on the management of patients who are candidates for cardiac replacement therapy.

Influence of inguinal hernia repair on sperm autoimmunity: The largest single center experience.

BACKGROUND: Studies on immunological infertility after inguinal hernia correction are few and not very representative. Anti-sperm antibodies have been shown to reduce male fertility. Although the extent of infertility due to anti-sperm antibodies alone is not very clear, data indicates that about 8%-10% of infertile patients have immunological infertility DESIGN: This retrospective study includes all infertile male patients (n = 2258) who underwent mixed antiglobulin reaction tests and urologic examination from 2000 to 2020. Sperm quality (assessed by the number of spermatozoa, their motility, vitality, and normal form) was also evaluated. Among these patients, 191 had previously undergone unilateral or bilateral inguinal hernia surgery repair. The aim of the study is to evaluate if there is a higher incidence of positive mixed antiglobulin reaction test among patients undergoing inguinal hernioplasty compared to the unselected infertile population. RESULTS: Anti-sperm antibodies would seem to increase in both patients who performed general andrological surgery and groin hernia correction, respectively 3.48 (95% Confidence Interval: 1.70-7.10; p < 0.001) and 2.45 (95% Confidence Interval: 1.01-5.99; p < 0.05) times more than the unselected infertile population. CONCLUSIONS: Mixed antiglobulin reaction test could be useful in patients undergone previous scrotal surgery or hernia correction men, to avoid false unexplained infertility diagnoses and to direct the couple to assisted reproductive technology procedures. Basal evaluation of spermatozoa does not actually consider andrological surgery as an indication to autoimmunity investigation.

[Between intensive care and palliative care at the time of CoViD-19.] / Fra cure intensive e cure palliative ai tempi di CoViD-19.

The pandemic infection caused by the virus SARS-CoV-2 has determined a severe imbalance between demand and actual supply of intensive care. The shortage of intensive care units (ICU) beds and ventilators for the treatment of patients with severe respiratory failure produced angst in the clinicians/intensivists who have to decide which patients admit to ICU and in which patients to implement palliative care. They have to apply specific clinical and ethical criteria, in emergency conditions. Proportionality and appropriateness criteria should be integrated with equity, equality, utility criteria, widening the distributive justice concept from the right of the patient to receive all available therapies to a right resources allocation during shortage, guided by public health ethic. The clinical criteria should include the disease severity, the number and severity of comorbidities, frailty, the organ failures and their stage, the patient's age, the functional autonomy and cognitive status. Consequently the first come-first served rule to ICU admission should not be applied. The patients not admitted to ICU due to clinical reasons and advanced stage diseases should receive a high quality palliative care, to obtain a good symptoms control (mainly dyspnea, anxiety and delirium) and to implement palliative sedation at the end of life. Finally particular attention should be paid to the bereavement management of the family/caregivers and in the right approach of psychological problems and Post-Traumatic Stress Disorder of health workers involved in the pandemia.

[Selection criteria to cardiac surgery, transcatheter valvular interventions, electrophysiology and pacing procedures in patients with advanced heart failure]. / Criteri per la selezione del paziente con scompenso cardiaco avanzato alle procedure di cardiochirurgia, interventistica valvolare, elettrofisiologia ed elettrostimolazione.

Prognosis of advanced heart failure (HF) patients, often elderly, frail and with multiple comorbidities, has significantly improved due to recent advancements in interventional cardiology. A multidisciplinary approach is essential in order to better identify patients that could benefit from invasive procedures, avoiding futility. For patients with HF, the Multidimensional Prognostic Index could help the clinician in predicting not only the prognosis but also future quality of life. For cardiac surgical candidates, predictive scores should combine traditional mortality scores with geriatric parameters including nutritional status, screening of delirium, disabilities and comorbidities, in order to help the Heart Team in taking the right approach (i.e. conservative vs invasive strategies). Similarly, the indication to the implantation of a cardioverter-defibrillator or to ablative procedures should consider both the complication rates and the real impact on the quality of life considering the expected net clinical benefit.In the terminal stages of HF the therapeutic target should be oriented to a palliative care approach. In this perspective, the figure of the palliativist plays a role of growing interest and should be integrated into the HF multidisciplinary team.

[Implantable cardiac device deactivation at the end of life]. / La disattivazione dei dispositivi cardiaci impiantabili alla fine della vita.

Treatment of patients with heart failure is based on drugs, cardiac surgery and implantable cardiac devices to prevent sudden cardiac death (implantable cardioverter-defibrillator [ICD]), to reverse left ventricular dysfunction associated with left bundle branch block (cardiac resynchronization therapy) or mechanical circulatory support in more advanced phases of heart failure (left ventricular assist devices [LVAD]).During the follow-up, patients may die from progression of their underlying heart disease or from non-arrhythmic causes, such as malignancies, multi-organ failure, stroke, etc., without benefits by implanted devices. Patients implanted with ICD could die from non-arrhythmic causes, without appropriate shocks until the last few days or weeks of their life. These events occur roughly in 30% of patients, mainly in the last 24 h before death. LVAD therapy may induce significant complications, such as infections, hemorrhagic stroke, thromboembolism, right ventricular failure. In these cases, inappropriate and even appropriate shock deliveries by ICD can no longer prolong life and may simply lead to pain and reduced quality of life, as well as LVAD may prolong life with painful distress due to complications. Therefore, it appears important to discuss early with the patients and their relatives about deactivation of ICD or LVAD at the end of life. The goal of this paper is to provide an overview of the ethical, clinical and communication issues of cardiac implanted device deactivation, with a special focus on issues associated with advance care planning, which require shared decision-making, including those related to end of life decisions (advance directives). Palliative care should be early implemented, particularly in patients with LVAD.

[Palliative care and heart failure: some remarks about cost-effectiveness and clinical results]. / Cure palliative e scompenso cardiaco: considerazioni su costo-efficacia e risultati clinici.

Early palliative care (PC) clearly demonstrated its efficacy in patients with heart failure (HF), reducing symptom burden, mainly pain and depression, improving quality of life, and reducing the access to the health care system. However, there are not conclusive data on economic cost reduction. The reasons are related to the few patients involved in the studies dedicated to this topic, to the different clinical settings, different modalities of provision and funding of PC, and different timing of PC implementation. PC was not shown to reduce mortality nor hospital readmissions in randomized trials.The unanswered questions will be clarified only in larger studies, defining specific clinical settings, goals to achieve and standardizing the provision and funding modalities in the different countries.

Facilitating supportive care in cardiac intensive care units.

PURPOSE OF REVIEW: The number of patients who die in the hospital in the Western world is high, and 20-30% of them are admitted to an ICU in the last month of life, including those in cardiac ICUs (CICUs) where invasive procedures are performed and mortality is high. Palliative consultation is provided in only a few cases. The ethical and decisional aspects associated with the advanced stages of illness are very rarely discussed. RECENT FINDINGS: The epidemiological and clinical landscape of CICUs has changed in the last decade; the incidence of acute coronary syndromes has decreased, whereas noncardiovascular diseases, comorbidities, the patients' age and clinical and therapeutic complexity have increased. The use of advanced and invasive treatments, such as mechanical ventilation, mechanical circulatory support and renal replacement therapies, has increased. This evolution increases the possibility of developing a life-threatening clinical event. SUMMARY: This review aimed to analyze the main epidemiological, clinical, ethical and training aspects that can facilitate the introduction of supportive/palliative care programs in the CICU to improve symptom management during the advanced/terminal stages of illness, and address such issues as advance care planning, withdrawing/withholding life-sustaining treatments, deactivation of implantable defibrillators and palliative sedation.

[Wearable cardioverter-defibrillators: clinical experience and future perspectives]. / Il defibrillatore indossabile: evidenze cliniche e prospettive future.

Sudden cardiac death (SCD) can affect patients with ischemic or non-ischemic left ventricular dysfunction. Automatic implantable cardioverter-defibrillator (ICD) implantation is the most effective option for the treatment of malignant ventricular tachyarrhythmias; however, the procedure is burdened with known significant risks, even in the long term.In patients at high risk of SCD, either real or perceived, without a definite indication to ICD implantation, wearable cardioverter-defibrillators have been shown to offer effective temporary protection in different clinical settings, for patients with recent high-risk myocardial infarction with left ventricular dysfunction, even after myocardial revascularization procedures, heart failure with reduced ejection fraction, newly diagnosed dilated cardiomyopathy, ICD post-explant phase for infection, and bridge to cardiac transplantation.The purpose of this review is to describe the technical aspects and clinical results available in the literature on the use of wearable cardioverter-defibrillators, with particular reference to safety, efficacy, costs and patient selection, together with current and unconventional indications.The authors also report the first data related to their personal experience.

[Palliative care and heart failure: is it time to talk?] / Cure palliative e scompenso cardiaco: è ora di cominciare a parlarne?

Heart failure (HF) is one of the leading causes of hospitalization in high-income countries and has a profound negative impact on quality of life. In the United States there are more than 900,000 new cases per year and over one million hospital admissions with a primary diagnosis of HF. A prevalence of 6,500,000 cases (2.2% of the population of aged >20 years) was estimated for the US in 2014, in which there were 300,000 related deaths. Although survival has increased, thanks to the pharmacological and non pharmacological therapy, roughly 50% of HF patients die within 5 years of being diagnosed. HF is a chronic, progressive and incurable syndrome characterized by alternating periods of apparent stability and acute exacerbations, with frequent hospitalizations. Patients with HF experience a high level of symptoms and symptom burden over time, particularly at the end of life. In addition to classic symptoms such as dyspnea and edema, patients with HF frequently suffer additional symptoms such as pain, depression, gastrointestinal distress, thirst, fatigue and psychological distress. In HF patients the symptom burden is similar to cancer patients, but patients with advanced HF, in comparison to advanced cancer patients, have a greater number of physical symptoms, worse depression status and lower spiritual well-being. There is evidence that HF patients have the same palliative needs as cancer patients, roughly in 40% of cases, but only 20% actually are admitted to hospice programs in US. This situation seems to be the consequence of cultural gap between guidelines, addressing palliative care and HF, and clinical practice. Bridging this gap is a priority to implement an holistic approach to advanced HF.

Clinical Impact of a Surgical Energy Device in Advanced Ovarian Cancer Surgery Including Bowel Resection.

AIM: To evaluate the clinical impact of the use of the Caiman® articulating energy device in advanced ovarian cancer (AOC) including rectosigmoid resection [e.g. modified posterior exenteration (MPE)]. PATIENTS AND METHODS: This was a prospective single-institution observational study with women undergoing MPE where all soft-tissue dissections and vessel ligations were performed using the Caiman® device. Intraoperative and postoperative surgical data were collected. Bladder function after nerve-sparing surgery was analyzed before and 6 months after surgery. RESULTS: Forty patients were registered in the study. The median time for specimen removal using Caiman® was 86 min (range=70-120 min). Major vessel ligation was successful in all patients with a median of a single (range=1-4) Caiman® application to seal major vessels. No intraoperative or postoperative complications or bladder dysfunctions associated with the use of Caiman® were noted. CONCLUSION: Caiman® can be safely used in AOC surgery and may save time through faster dissection. However, comparative studies with other energy devices are needed to confirm this finding.

[Palliative care in the intensive cardiac care unit: a new competence for the cardiac intensivist]. / Cure palliative in unità di terapia intensiva cardiologica: una nuova competenza per il cardiologo intensivista.

Admissions to the intensive care unit at the end of life of patients with chronic non-malignant diseases are increasing. This involves the need for the development of palliative care culture and competence, also in the field of intensive cardiology. Palliative care should be implemented in the treatment of all patients with critical stages of disease, irrespective of prognosis, in order to improve the quality of care at the end of life.This review analyzes in detail the main clinical, ethical and communicational issues to move toward the introduction of basics of palliative care in cardiac intensive care units. It outlines the importance of shared decision-making with the patient and his family, with special attention to withholding/withdrawing of life-sustaining treatments, palliative sedation, main symptom control, patient and family psychological support.

[Implantable cardioverter-defibrillator deactivation at the end of life: ethical, clinical and communication issues]. / La disattivazione del defibrillatore impiantabile alla fine della vita: etica, clinica, comunicazione.

The number of cardioverter-defibrillator implants is increasing worldwide, with the main indication being primary prevention of sudden cardiac death. During the follow-up, patients may die from progression of their underlying heart disease or from nonarrhythmic causes, such as malignancies, dementia and lung disease, without receiving appropriate shocks until the last few days or weeks of their life. These events occur roughly in 30% of patients, mainly in the last 24 hours before death. In this case, inappropriate and even appropriate shock deliveries can no longer prolong life and may simply lead to pain and reduced quality of life. Therefore, it appears important to discuss early with the patients and their relatives about deactivation of the implantable cardioverter-defibrillator (ICD) at the end of life.The goal of this review is to provide an overview of the ethical, clinical and communication issues of ICD deactivation, with a special focus on patients' wishes. It is outlined that patients are not adequately informed about risks and benefits of ICD and the option of ICD deactivation; the doctors are not used to discuss with the patients the topics of end-of-life decisions. Complete information must be part of current informed consent before ICD implantation and should be updated during the follow-up, with special attention to patients with heart failure in relation to their prognosis and advance directives, as suggested by international guidelines.

[Futility in Cardiology]. / La futilità in Cardiologia.

Medical futility refers to interventions that are unlikely to produce any significant benefit for the patient. Medical and technological resources allow many patients affected by advanced cardiovascular diseases to receive more aggressive and expensive treatments than ever before. This wide range of available options can frequently lead to the delay of complex end-of-life decisions, such as starting palliative care programs. Medical futility is a daily problem, with significant ethical implications and concerns about the respect of the main ethics points: non maleficence, patient's autonomy, and justice. This paper examines some considerations and applications of the concept of medical futility, particularly about the various definitions of futility, the complexities of management when care is considered futile and the ethical and clinical criteria to withdrawing or withholding aggressive treatments. The patient-centered care, based on physician-patient communication, seems to be the best approach to this problem, even with a patient with advanced heart disease. Finally, the increasing power of technology and its relationship with the current cultural values of the developed societies are outlined, particularly when end-of-life decisions are addressed.

[Part I. End-stage chronic organ failures: a position paper on shared care planning. The Integrated Care Pathway]. / Parte I. Il percorso clinico e assistenziale nelle insufficienze croniche d'organo "end-stage".Documento di consenso per una pianificazione condivisa delle scelte di cura.

In Italy the birth rate decrease together with the continuous improvement of living conditions on one hand, and the health care progress on the other hand, led in recent years to an increasing number of patients with chronic mono- or multi-organ failures and in an extension of their life expectancy. However, the natural history of chronic failures has not changed and the inescapable disease's worsening at the end makes more rare remissions, increasing hospital admissions rate and length of stay. Thus, when the "end-stage" get close clinicians have to engage the patient and his relatives in an advance care planning aimed to share a decision making process regarding all future treatments and related ethical choices such as patient's best interests, rights, values, and priorities. A right approach to the chronic organ failures end-stage patients consists therefore of a careful balance between the new powers of intervention provided by the biotechnology and pharmacology (intensive care), both with the quality of remaining life supplied by physicians to these patients (proportionality and beneficence) and the effective resources rationing and allocation (distributive justice). However, uncertainty still marks the criteria used by doctors to assess prognosis of these patients in order to make decisions concerning intensive or palliative care. The integrated care pathway suggested in this position paper shared by nine Italian medical societies, has to be intended as a guide focused to identify end-stage patients and choosing for them the best care option between intensive treatments and palliative care.

[Withholding and withdrawing therapy in cardiac intensive care units: ethical and clinical criteria in end-of-life decisions]. / La desistenza terapeutica in unità di terapia intensiva cardiologica: criteri decisionali fra etica e clinica.

In the last years dramatic changes in clinical and epidemiological characteristics of patients admitted to cardiac intensive care units have been observed. Aging population, non-ischemic cardiovascular diseases, acute and chronic severe comorbidities, all increased the susceptibility to develop life-threatening critical settings. In this context, palliative care programs are needed more frequently. In this review, the ethical and clinical criteria to withdrawing and withholding artificial cardiocirculatory, respiratory and renal supports are analyzed, as well as the cultural delays of cardiologists involved in this peculiar clinical setting.

Right ventricular myocardial function in patients with either idiopathic or ischemic dilated cardiomyopathy without clinical sign of right heart failure: effects of cardiac resynchronization therapy.

OBJECTIVE: In dilated cardiomyopathy (DCM), right ventricular (RV) dysfunction has been reported and attributed both to altered loading conditions and to RV involvement in the myopathic process. The aim of the study was to detect RV myocardial function in DCM using two-dimensional (2D) strain echocardiography and to assess the effects of cardiac resynchronization therapy (CRT) on RV myocardial strain during a 6-month follow-up. METHODS AND RESULTS: A total of 110 patients (mean age: 55.4 +/- 11.2 years) with either idiopathic (n = 60) or ischemic (n = 50) DCM, without overt clinical signs of RV failure, underwent standard echo and 2D strain analysis of RV longitudinal strain in RV septal and lateral walls. The two groups were comparable for clinical variables (New York Heart Association class III in 81.8%). Left ventricular volumes, ejection fraction, stroke volume, and mitral valve effective regurgitant orifice were similar between the two groups. No significant differences were evidenced in Doppler mitral and tricuspid inflow measurements. RV diameters were mildly increased in patients with idiopathic DCM, while RV tricuspid annulus systolic excursion and Tei-index were comparable between the two groups. RV global longitudinal strain and regional peak myocardial strain were significantly impaired in patients with idiopathic DCM compared with those having ischemic DCM (all P < 0.001). Using left ventricular end-systolic volume as marker for response to CRT, 70 patients (63.3%) were long-term responders. Ischemic DCM patient responders to CRT showed a significant improvement in RV peak systolic strain. Conversely, in patients with idiopathic DCM and in ischemic patients nonresponders to CRT, no improvement in RV function was evidenced. By multivariable analysis, in the overall population, ischemic etiology of DCM (P < 0.0001), positive response to CRT (P < 0.001), and longitudinal intraventricular dyssynchrony (P <0.01) emerged as the only independent determinants of RV global longitudinal strain after CRT. CONCLUSIONS: Two-dimensional strain represents a promising noninvasive technique to assess RV myocardial function in patients with DCM. RV myocardial deformation at baseline and after CRT are more impaired in idiopathic compared with ischemic DCM patients. Future longitudinal studies are warranted to understand the natural history of RV myocardial function, the extent of reversibility of RV dysfunction with CRT, and the possible prognostic impact of such indexes in patients with congestive heart failure.