The artificial heart. Costs, risks, and benefits--an update.

As discussed above, approximately 32,500 persons aged 55 to 70 years with end-stage heart disease may be potential candidates for the artificial heart each year. However, continued application of a protocol that requires informed consent by the patient effectively limits the pool to 12,000 annually. Estimates of the cost of the artificial heart include charges for the surgical procedure, device and console, and continuing medical surveillance. These estimates range from a low of $100,000 to a high of $300,000 per patient in the initial year. Assuming a five-year, 51% survival and an initial cost of $100,000, total program costs in the fifth year are projected to be $1.3 billion for a pool of 12,000 patients, and $3.8 billion for 32,500 patients. These projected costs are associated with anticipated increases in life expectancy. For those individuals destined to develop heart disease, the anticipated average increase is approximately half a year. In comparison, heart transplant patients who meet the surgical criteria but who do not receive a new heart do not survival beyond six months. In an era of limited resources, it is imperative that such a potentially expensive innovation as the artificial heart be compared carefully with other social and medical programs designed to extend life and improve its quality. Such a comparison will require a full understanding of the likely costs and benefits of the device. A viable artificial heart would greatly alter current treatment for end-stage cardiac disease. More patients would benefit from this therapy than currently benefit from heart transplants, and the costs of caring for these patients would increase substantially. The current state of development of the artificial heart provides an opportunity to collect data on investigational artificial heart performance, clinical results, patient status, and economic and social costs. This knowledge base would be invaluable for future technology assessments and policy decisions regarding third party reimbursement. Insofar as we may be faced with a multi-billion dollar annual investment in the future, detailed assessments of the artificial heart should be performed.     

The use of advance directives among patients with left ventricular assist devices

Patients who undergo implantation of left ventricular assist devices (LVADs) often have improved quality of life, but may eventually succumb to their heart failure and/or sustain LVAD-related complications. In end-of-life situations, decisions must be made about when to deactivate LVAD support. Previous studies have demonstrated that end-of-life planning, particularly with the use of advance directives (ADs), can clarify patients' end-of-life preferences when they are unable to speak for themselves. However, many patients do not have ADs, and among patients who do, the ADs may lack useful information on how to guide care surrogates and clinicians regarding patients' preferences on life-sustaining treatments. The authors retrospectively reviewed the charts of 68 patients with advanced heart failure (56 men [82%]; mean [standard deviation] age, 59.0 ± 12.2 years) who underwent LVAD implantation between March 2003 and January 2009. The indication for the LVAD was destination therapy in 36 (53%) patients and bridge to heart transplant in 32 (47%) patients. Overall, 32 (47%) patients had ADs of varying types; 25 (78%) ADs were completed before LVAD implantation. Although life-sustaining treatments (eg, tube feeding, cardiopulmonary resuscitation, mechanical ventilation, and hemodialysis) were mentioned, none explicitly mentioned the LVAD or withdrawal of LVAD support at the end of life. We hypothesize that if instructions regarding LVAD management in ADs are explicit, surrogate and clinician distress may decrease, and ethical dilemmas may be avoided.     

Prospective study of the quality of life in patients assessed for liver transplantation: outcome in transplanted and not transplanted groups.

The quality of life in adult patients with chronic liver disease who were considered for transplantation was assessed prospectively over a 2 year period, for both those who did and did not subsequently receive transplants. The main outcome measures were the Nottingham Health Profile and survival. Of the 109 patients who completed an entry profile, 27 were transplanted, 71 not transplanted during the study period, and 11 rejected for transplant. Quality of life and severity of liver disease at entry was worse for the transplant group, whose survival at 15 months from entry was 81% compared with 78% for those not transplanted. Among transplant survivors there were marked improvements in quality of life, whilst amongst those not receiving transplants there was little change. In conclusion, liver transplantation was effective in improving quality of life in patients with chronic liver disease, but comparison between transplant and non-transplant patients is difficult because of differences between the groups.     

Alcoholic liver disease: to transplant or not to transplant?

Liver transplantation for patients with alcoholic liver disease remains very controversial. We review recent data which suggest that, contrary to earlier reports, many alcoholic patients with end-stage liver disease are able to meet stringent selection criteria and that these selected alcoholics achieve a good result from a liver transplant. Conversely, non-selected alcoholics have a significantly poorer survival. This raises the question as to what is the most appropriate method to select alcoholic patients for liver transplantation. We advocate a selection process which considers the potential recipients' medical, surgical and psychiatric suitability rather than their diagnosis. We outline how we have arrived at this approach in part because of the heterogeneity of patients who carry the diagnosis 'alcoholic liver disease'. We describe how we try to estimate prognosis for future abstinence, which is based on a profile of historical features rather than a fixed period of sobriety. Using this approach, the incidence of recidivism in the first 2 years after transplantation has been low. Prospective longitudinal studies are needed to improve methods of selection for the management of alcoholic patients undergoing liver transplantation.     

Short-Term Aggressive Disease Management Programs for Heart Failure

Cardiovascular disease is the leading cause of death in developed countries. It is estimated that about 15 million people worldwide die every year from heart disease, with a substantial proportion of these deaths occurring in developing nations. Congestive heart failure (CHF) is a condition that develops as a late complication from a variety of heart disease states. CHF remains a devastating disease. It exacts a high toll in terms of mortality and morbidity and carries a high price burden. As the population ages and treatments for conditions such as acute coronary syndrome and hypertension improve, the prevalence of heart failure can be expected to increase, because survivors of hypertension and myocardial infarction live long enough to develop complications such as congestive heart failure.Recent advances have clearly shown that treatment strategies including ACE inhibitors, β-adrenoceptor antagonists, and aldosterone inhibitors improve morbidity and survival. However, even among patients treated with recommended therapy at recommended doses, mortality remains high. Opportunities exist for further improvement of prognosis beyond current guidelines for heart failure. As new evidence emerges, it is evident that survival can be further improved by using other strategies such as angiotensin receptor antagonists as alternative or add-on therapy and ventricular resynchronization for qualifying candidates.The management of heart failure patients in the community presents unique challenges. Patients who are managed in community hospitals are often elderly and/or very ill, with several comorbidities and clinical characteristics that may be different from patients who qualify for clinical trials. Furthermore, there appears to be a delay in incorporating scientific evidence into practice and studies continue to show that many heart failure patients do not receive recommended medications at adequate doses.Disease management programs have evolved as a way of improving heart failure care. Different models have been established and some institutions have published the results of their specific programs. The consistent findings include reductions in hospitalization rates, improvements in quality of life, and reductions in cost. However, to date, such studies have not compared different models and until large prospective trials are available, the true benefits of these programs will continue to be debated.     

Potential role of ubiquinone (coenzyme Q10) in pediatric cardiomyopathy

Pediatric cardiomyopathy (PCM) represents a group of rare and heterogeneous disorders that often results in death. While there is a large body of literature on adult cardiomyopathy, all of the information is not necessarily relevant to children with PCM. About 40% of children who present with symptomatic cardiomyopathy are reported to receive a heart transplant or die within the first two years of life. In spite of some of the advances in the management of PCM, the data shows that the time to transplantation or death has not improved during the past 35 years. Coenzyme Q10 is a vitamin-like nutrient that has a fundamental role in mitochondrial function, especially as it relates to the production of energy (ATP) and also as an antioxidant. Based upon the biochemical rationale and a large body of data on patients with adult cardiomyopathy, heart failure, and mitochondrial diseases with heart involvement, a role for coenzyme Q10 therapy in PCM patients is indicated, and preliminary results are promising. Additional studies on the potential usefulness of coenzyme Q10 supplementation as an adjunct to conventional therapy in PCM, particularly in children with dilated cardiomyopathy, are therefore warranted.     

Psychosocial problems of donor heart recipients adversely affecting quality of life

Heart transplantation has become an accepted therapy for patients suffering from terminal heart disease for whom neither standard forms of medication nor the usual surgery are of any benefit. Although results regarding postoperative quantity and quality of life are encouraging, it must not be overlooked that the patient and his family face, and have to overcome, profound psychosocial problems. The main stressors were identified in interviews with 47 heart transplant patients. The main preoperative problems were: the way of being informed about the diagnosis, the waiting period for transplantation, anguishing doubts about the decision to have a transplant, being a body without heart (zombie), guilt and shame regarding the donor, the reactions of others. Postoperatively the patients have to cope with: re-entering social systems, reactions of friends, neighbours and colleagues, rejection episodes, death of a fellow patient, the need to redesign family life. All the problems reported by the patients interviewed are discussed regarding their psychosocial implications, and hints are given on how to minimize them.     

冠心病患者康复护理研究进展

冠心病或缺血性心脏病,由于心脏动脉斑块的形成,导致心肌血流量减少,是最常见的心血管疾病,包括稳定型心绞痛、不稳定型心绞痛、心肌梗死和心源性猝死.常见的症状是胸痛或不适,可能蔓延到肩部、手臂、背部和颈部.近年来我国患有冠心病的人数较多,常发于年龄＞40岁的男性群体,并且受到社会压力、不健康生活习惯及遗传等因素影响,导致该...     

Nebulized opioids to treat dyspnea

Breathlessness secondary to cancer and nonmalignant disease is very distressing and exhausting to patients and families. Patient quality of life and functionality can be greatly improved with effective management. The pathophysiology and treatment of dyspnea are where the science of pain management was 20 years ago. While the optimal therapy for dyspnea would be to treat the underlying cause, this is frequently not possible. Research results evaluating dosages and effectiveness of nebulized morphine are conflicting. Some researchers have reported dramatic benefit to patients in relieving the symptoms of dyspnea, increasing exercise endurance, and improving function. Other studies have reported no significant differences between nebulized morphine and saline with or without oxygen. Studies that administer single predetermined doses that are not titrated to relief in patients that do not have end-stage lung or cardiac disease may report false-negative results. Other factors such as the placebo effect of saline and oxygen, if not controlled, may cause false-positive results. The dramatic positive benefits documented warrant further investigation on the appropriate patient selection criteria and therapeutic potential. Clearly, large scale randomized trials on opioid nebulized treatments for patients with severe dyspnea need to be published to reach a clear consensus outlining efficacy and administration parameters. Until that time, we must rely on anecdotal reports for treatment options. Such reports of the effectiveness of nebulized morphine as an alternative to hospital or hospice admission are encouraging for patients and family members managing severe dyspnea in the home.     

Chronic kidney disease in human immunodeficiency virus infection

The number of people living with human immunodeficiency virus (HIV) worldwide was estimated to be 39.5 million in 2006, 2.6 million more than in 2004. The manifestations of HIV infection in the kidney are multiple and varied, highlighting the complexity of the disease process. There is a wide spectrum of renal disease that occurs in the course of HIV infection. Biopsy studies reveal varying frequencies of histological patterns. HIV-associated nephropathy (HIVAN) is most common. A biopsy study at Chris Baragwanath Hospital in Soweto, South Africa showed that HIVAN was present in 27% and immune complex disease in 21%. Han et al. studied HIV-positive patients in Durban, South Africa and screened for proteinuria, including microalbuminuria. They found persistent proteinuria in 6%; HIVAN in 21/30 (72.4%) and the prevalence of HIVAN in patients with persistent microalbuminuria was 85.7%. Studies in black patients have shown a higher prevalence of both severe glomerular lesions (focal glomerulosclerosis) and nephrotic range proteinuria with renal dysfunction in the presence of normo-hypotension. There have been no prospective randomised controlled studies with any form of therapy for HIVAN to date. Therapy of HIVAN has included corticosteroids, cyclosporine and antiretroviral therapy (ART). ART appears to be a logical choice in the management of HIV-associated renal disease. Regimens containing protease inhibitors have been shown to be associated with significant slowing of the decline in creatinine clearance. Both peritoneal dialysis and haemodialysis are appropriate treatment modalities for HIV-infected patients with end stage renal disease. The choice of dialysis modality between haemodialysis and peritoneal dialysis is not a factor in predicting survival, if patients are stable on ART. Preliminary short-term data in case reports and small cohorts of liver, kidney, and heart transplant recipients suggest that patient survival rates may be similar to those in HIV-uninfected transplant recipients. However, high rates of acute and chronic rejection have been observed among HIV-infected kidney transplant recipients. The Infectious Diseases Society of America (IDSA) published guidelines in 2005, recommending that all individuals be assessed for kidney disease at the time of diagnosis of HIV infection with a screening urinalysis for proteinuria and a calculated estimate of renal function. Therefore any patient with persistent proteinuria, persistent haematuria or glomerular filtration rate < 60 mL/min per 1.73 m(2) should be referred to an institution where a specialist can evaluate this patient for further investigations. An integrated plan to reduce the progression to kidney failure together with lifestyle measures, focusing also on high risk groups with effective management at all levels of chronic kidney disease remains essential.     

Transient effects in the cox proportional hazards regression model

We consider a model for mortality rates that includes both the long and short term effects of switching from an initial to a second state, for example, when patients receive an initial treatment and then switch to a second treatment. We include transient effects associated with the switch in the model through the use of time-dependent covariates. One can choose the form of the time-dependent covariate to correspond with a variety of possible transition patterns. We use an exponential decay model to compare the survival experience of transplant versus dialysis treatment of end stage renal disease (ESRD) patients from the Michigan Kidney Registry (MKR). This model involves a hazard function that has an initial effect in mortality at the time of transplant, expected to be higher, followed by a smooth exponential decay to a long term effect, expected to be lower than the risk for those remaining on dialysis. Cox and Oakes used this model to analyse the Stanford Heart Transplant data. The model implicitly suggests there is a time at which the hazard curves (and survival curves) for the treatment groups cross. Those crossing times are useful in advising patients who have the option of receiving a transplant. We describe methods for obtaining estimates of the crossing times and their associated variances, and then apply them in analysing the MKR data.     

Selection on atherosclerosis as an explanation of the attenuated cholesterol-mortality relation in coronary heart disease populations

Recent studies of patients with coronary heart disease (CHD) at baseline have shown that their cholesterol levels are much less predictive of subsequent mortality than in populations free of CHD (FCHD). One previously suggested explanation of this attenuation is that the impact of hyperlipidemia on atherosclerosis or of atherosclerosis on mortality is reduced for post-myocardial infarction patients. In this paper it is shown that an alternative explanation is selection of CHD populations from FCHD populations for higher atherosclerosis levels. Data from all known follow-up studies on patients with baseline coronary angiograms are assembled to yield relations between cholesterol, atherosclerosis and mortality in CHD and FCHD populations. These data show that the selection hypothesis is not only logically possible but is also consistent with presently available epidemiologic information on relations between these three variables. An ethically impracticable large prospective study of a FCHD population with baseline angiograms might, however, be needed to choose definitively between the selection and reduced impact hypotheses.     

Cardiac rehabilitation in patients with a congenital heart disease, an implantable cardioverter defibrillator or chronic heart failure

Cardiac rehabilitation is no longer just used to treat patients after the manifestation of a coronary artery disease such as a myocardial infarct, after a PTCA or after a coronary bypass operation. Patients with a congenital heart disease, patients who have received an implantable cardioverter defibrillator (ICD) and patients with stable chronic heart failure are also suitable candidates for a multidisciplinary cardiac rehabilitation programme. The new Dutch guidelines for cardiac rehabilitation, published in 2004, can be helpful in identifying potential candidates for a programme. Physical training is often a component of the treatment, but psycho-social counselling and education targeted at reducing anxiety and uncertainty, accepting the heart disease and learning to cope with it, can be just as important as those aspects targeted at improving the physical condition. Cardiac rehabilitation that includes physical training is safe for patients with congenital heart disease, for patients who have undergone an ICD implantation and for patients with stable chronic heart failure, as long as the pretraining exercise test is given a guiding role in selecting the appropriate physical work load. Patients with stable chronic heart failure should continue their physical training in order to maintain its beneficial physical and psychological effects.     

Why it Pays for Hospitals to Initiate a Heart Failure Disease Management Program

Heart failure is a clinical syndrome usually caused by structural changes in the heart. These changes result in varying degrees of symptomatic functional limitation, typically shortness of breath and fatigue. Heart failure is common, with a lifetime risk for its occurrence in a healthy 40-year-old of 20%. In the US, the cost of heart failure care is now estimated at over $US30 billion annually (year 2007 values).Several forms of treatment have been devised for heart failure: medical, device based, and surgical. These are best individualized to each patient and used in stepped progression to goals that are based on current expert guidelines. When goal-directed treatment is accomplished, three major outcomes are expected: (i) symptom relief and improved quality of life; (ii) a slowing or partial reversal of cardiac structural abnormalities; and (iii) a reduction in mortality.Attempts to deliver care for this complex syndrome have led to the development of heart failure-specific disease management programs. These programs can take different forms. Some involve multi-disciplinary teams that comprise a wide array of specialized physicians, cardiac surgeons, nurses, and other allied health workers, all with specific tasks. Others have a more narrow focus and are nurse-led programs. These programs, when fully implemented, help the patient manage his/her disease more effectively through education about heart failure, the purpose and correct use of medication, and the full utilization of nutritional interventions. These programs are also ideally suited to deliver care for patients with end-stage disease, particularly those needing implantation of left ventricular assist devices or transplantation.When effectively implemented, these programs have been shown to improve quality of life, decrease rate of heart failure hospitalizations, and improve survival compared with usual care. Cost analyses of these programs are challenging, and in the most favorable circumstances the greater up-front cost of more intense care is paid back by a lower rate of utilization of inpatient resources. The details of the University of Wisconsin Program are discussed as an example of a comprehensive management program.     

Including a 'no active intervention' arm in surgical trials is possible: evidence from the CLasP randomised trial

OBJECTIVES: To examine the impact of including a 'no active intervention' arm (called 'conservative management') in a randomised controlled trial comparing treatments (including surgery) for men with lower urinary tract symptoms related to benign prostatic enlargement. METHODS: Outcomes 7.5 months after randomisation were acceptability of randomisation, overall acceptability of and satisfaction with conservative management, impact on quality of life, perceived need for further treatment and treatment failure (defined a priori). RESULTS: In total, 177 (out of 755) patients refused randomisation, including 31% who did not want surgery and 22% who wanted surgery. Most men randomised to conservative management were willing to undertake it as part of a trial but at the end of the trial they were divided between those who wanted to continue with it and those who expected surgery. At follow-up, 39% of conservative management patients requested surgery, and interference of symptoms with life and an unsuccessful outcome were more commonly reported in this arm. There were no appreciable differences between treatment groups in terms of treatment failures. CONCLUSIONS: Including a 'no active intervention' arm did not appear to have a detrimental effect on patient recruitment or the completion of this trial in the short-term; overall, conservative management was successfully completed by the majority of patients during the trial period, suggesting that researchers need not avoid including a no-intervention arm in surgical trials as long as they take care with its presentation.     

A conceptual framework of quality of life in chronic kidney disease in Turkey: A patient-focused approach

This study aimed to determine the quality of life of patients with chronic kidney disease who were receiving dialysis treatment. It also aimed to identify the factors affecting the quality of life of these patients. The independent variables analyzed were: patients' sociodemographic characteristics, organizational characteristics, adherence to treatment, patient-physician relationship, and patient activation level. The sample consisted of 328 patients with chronic kidney disease who received services from dialysis units of two university hospitals and two private dialysis centers. Data analysis was performed through multivariate regression. Results showed that receiving treatment from a hospital-based dialysis unit may have a positive effect in patients' quality of life; and patient-physician relationship, patient activity, and adherence to treatment may positively affect quality of life. Thus, planning of health service delivery that focus on improving the quality of life of patients who are more active by allowing them to establish positive relationships with their physicians and to have a better adherence to treatment should be adopted. These findings may provide health managers, health professionals, and individual patients with evidence-based information about treatment management and health service planning processes related to chronic kidney disease.     

Improving Treatment Regimen Adherence in Coronary Heart Disease by Targeting Patient Types

Patient adherence to a treatment plan is central to the control of coronary heart disease (CHD) and in the prevention of complications; it is reported to be the single most important challenge in the management of CHD and related conditions. The following article provides an overview of adherence in CHD, with particular emphasis on two important theories of behavior change: the ‘Health Belief Model’ and the ‘Transtheoretical Model’. Three types of individuals are discussed in relation to these theories: (i) patients who are non-adherent (5–10% of the CHD population); (ii) patients who are partially adherent (30–40% of the CHD population); and (iii) patients who are near-optimally adherent (50–60% of the CHD population). Adherence predictor strategies and recommended interventions for each of these groups are provided in table format. Disease management tools and resources that assist in targeting interventions to the unique adherence needs of these three very different groups are also listed. It was our conclusion that regardless of the interventions that are utilized in CHD management programs, understanding the differences between partially adherent, non-adherent, and near-optimally adherent patients, and targeting interventions to these groups, can optimize the impact of CHD interventions.     

Cystic fibrosis in adolescents and young adults.

With the early diagnosis of cystic fibrosis and the better management of these patients in childhood increasing numbers are surviving to adult life. The main problem requiring continuous medical care in the older cystic fibrosis patient is persisting and often progressive chest disease. For this reason the cystic fibrosis clinic for adolescents and young adults was started in the Western Infirmary in 1975. This paper presents our observations on 13 patients who had attended between 1975 and 1977. Eleven patients are alive and well and have shown no evidence of deterioration over this period. Ten are at school or in regular employment. With optimum medical supervision it is possible to give young adults with cystic fibrosis a worthwhile existence.     

Quality of life of hemodialysis and renal transplantation patients

The quality of life of patients with end-stage renal disease is an important indicator of disease burden. To achieve a better quality of life, some medical treatment might be replaced by other approaches. The aim of this study was to compare the quality of life of renal-transplanted and hemodialysis patients in Iran. Two hundred hemodialysis and 200 renal transplantation patients were recruited from 5 major hospitals and renal patients' support society in Tehran, Iran. The data were collected using the Persian versions of the Ferrans and Powers Quality of Life Index-Dialysis and Transplantation Version. The quality-of-life mean scores of renal transplantation patients were significantly better compared with those of the hemodialysis patients (21.36 [SD, 4.06] vs 20.35 [SD, 5.14]; P = .03). The questionnaire demonstrated significant differences in health/functioning and familial subscale of quality of life between the transplanted and hemodialysis patients (p < .05). The better quality of life of transplant patients, in comparison with hemodialysis patients, is an important reason for advising kidney transplants in renal failure patients. To improve the patients' quality of life, kidney transplantation might be effective for the end-stage renal disease. With regard to socioeconomic problem in most of the patients with renal failure, comprehensive insurance and referral to renal and transplanted patients' support society are suggested for those who have undergone different renal replacement therapies.     

Glaucoma

Migraine is a common chronic headache disorder affecting more than 10% of persons in Western populations. The clinical management of migraine is notable for the variability of diagnostic testing, therapeutic interventions and cost. Standards of care and clinical guidelines for migraine have recently been published or are currently under development. For these reasons, migraine is an ideal disease for a disease management programme.This article outlines the key concepts in developing a disease management programme for migraine which include: setting appropriate goals of migraine disease management; identifying patients for enrolment; providing critical components of care; instituting appropriate referral guidelines; and using continuous quality improvement methods to reach desired goals. Appropriate goals of migraine disease management should focus on decreasing migraine frequency and/or severity and improving quality of life for individuals who experience migraine.Additional goals may include reducing: overall cost to the organisation; pharmacy costs for migraine therapies; and emergency department and urgent care patient visits. Methods for identifying patients for enrolment in a migraine disease management programme include screening patients in various clinical settings, reviewing pharmacy records or self-enrolment. Key components of care include diagnostic and treatment algorithms, instruments to monitor quality of life, and education programmes for practitioners and patients. The final step in designing a disease management approach to migraine is to ensure that the process is continuously undergoing analysis and improvement.