Cost-effectiveness of extracorporeal cardiopulmonary resuscitation vs. conventional cardiopulmonary resuscitation in out-of-hospital cardiac arrest: a pre-planned, trial-based economic evaluation.

AIMS: When out-of-hospital cardiac arrest (OHCA) becomes refractory, extracorporeal cardiopulmonary resuscitation (ECPR) is a potential option to restore circulation and improve the patient's outcome. However, ECPR requires specific materials and highly skilled personnel, and it is unclear whether increased survival and health-related quality of life (HRQOL) justify these costs. METHODS AND RESULTS: This cost-effectiveness study was part of the INCEPTION study, a multi-centre, pragmatic randomized trial comparing hospital-based ECPR to conventional CPR (CCPR) in patients with refractory OHCA in 10 cardiosurgical centres in the Netherlands. We analysed healthcare costs in the first year and measured HRQOL using the EQ-5D-5L at 1, 3, 6, and 12 months. Incremental cost-effectiveness ratios (ICERs), cost-effectiveness planes, and acceptability curves were calculated. Sensitivity analyses were performed for per-protocol and as-treated subgroups as well as imputed productivity loss in deceased patients. In total, 132 patients were enrolled: 62 in the CCPR and 70 in the ECPR group. The difference in mean costs after 1 year was €5109 (95% confidence interval -7264 to 15 764). Mean quality-adjusted life year (QALY) after 1 year was 0.15 in the ECPR group and 0.11 in the CCPR group, resulting in an ICER of €121 643 per additional QALY gained. The acceptability curve shows that at a willingness-to-pay threshold of €80.000, the probability of ECPR being cost-effective compared with CCPR is 36%. Sensitivity analysis showed increasing ICER in the per-protocol and as-treated groups and lower probabilities of acceptance. CONCLUSION: Hospital-based ECPR in refractory OHCA has a low probability of being cost-effective in a trial-based economic evaluation.

The Global Burden of Valvular Heart Disease: From Clinical Epidemiology to Management.

Valvular heart disease is a leading cause of cardiovascular morbidity and mortality and a major contributor of symptoms and functional disability. Knowledge of valvular heart disease epidemiology and a deep comprehension of the geographical and temporal trends are crucial for clinical advances and the formulation of effective health policy for primary and secondary prevention. This review mainly focuses on the epidemiology of primary (organic, related to the valve itself) valvular disease and its management, especially emphasizing the importance of heart valve centers in ensuring the best care of patients through a multidisciplinary team.

Health-related quality of life, one-year costs and economic evaluation in extracorporeal membrane oxygenation in critically ill adults.

PURPOSE: This study reports on survival and health related quality of life (HRQOL) after extracorporeal membrane oxygenation (ECMO) treatment and the associated costs in the first year. MATERIALS AND METHODS: Prospective observational cohort study patients receiving ECMO in the intensive care unit during August 2017 and July 2019. We analyzed all healthcare costs in the first year after index admission. Follow-up included a HRQOL analysis using the EQ-5D-5L at 6 and 12 months. RESULTS: The study enrolled 428 patients with an ECMO run during their critical care admission. The one-year mortality was 50%. Follow up was available for 124 patients at 12 months. Survivors reported a favorable mean HRQOL (utility) of 0.71 (scale 0-1) at 12 months of 0.77. The overall health status (VAS, scale 0-100) was reported as 73.6 at 12 months. Mean total costs during the first year were $204,513 ± 211,590 with hospital costs as the major factor contributing to the total costs. Follow up costs were $53,752 ± 65,051 and costs of absenteeism were $7317 ± 17,036. CONCLUSIONS: At one year after hospital admission requiring ECMO the health-related quality of life is favorable with substantial costs but considering the survival might be acceptable. However, our results are limited by loss of follow up. So it may be possible that only the best-recovered patients returned their questionnaires. This potential bias might lead to higher costs and worse HRQOL in a real-life scenario.

Extracorporeal cardiopulmonary resuscitation in adults: evidence and implications.

Rates of survival with functional recovery for both in-hospital and out-of-hospital cardiac arrest are notably low. Extracorporeal cardiopulmonary resuscitation (ECPR) is emerging as a modality to improve prognosis by augmenting perfusion to vital end-organs by utilizing extracorporeal membrane oxygenation (ECMO) during conventional CPR and stabilizing the patient for interventions aimed at reversing the aetiology of the arrest. Implementing this emergent procedure requires a substantial investment in resources, and even the most successful ECPR programs may nonetheless burden healthcare systems, clinicians, patients, and their families with unsalvageable patients supported by extracorporeal devices. Non-randomized and observational studies have repeatedly shown an association between ECPR and improved survival, versus conventional CPR, for in-hospital cardiac arrest in select patient populations. Recently, randomized controlled trials suggest benefit for ECPR over standard resuscitation, as well as the feasibility of performing such trials, in out-of-hospital cardiac arrest within highly coordinated healthcare delivery systems. Application of these data to clinical practice should be done cautiously, with outcomes likely to vary by the setting and system within which ECPR is initiated. ECPR introduces important ethical challenges, including whether it should be considered an extension of CPR, at what point it becomes sustained organ replacement therapy, and how to approach patients unable to recover or be bridged to heart replacement therapy. The economic impact of ECPR varies by health system, and has the potential to outstrip resources if used indiscriminately. Ideally, studies should include economic evaluations to inform health care systems about the cost-benefits of this therapy.

Allocating scarce intensive care resources during the COVID-19 pandemic: practical challenges to theoretical frameworks.

The COVID-19 pandemic strained health-care systems throughout the world. For some, available medical resources could not meet the increased demand and rationing was ultimately required. Hospitals and governments often sought to establish triage committees to assist with allocation decisions. However, for institutions operating under crisis standards of care (during times when standards of care must be substantially lowered in the setting of crisis), relying on these committees for rationing decisions was impractical-circumstances were changing too rapidly, occurring in too many diverse locations within hospitals, and the available information for decision making was notably scarce. Furthermore, a utilitarian approach to decision making based on an analysis of outcomes is problematic due to uncertainty regarding outcomes of different therapeutic options. We propose that triage committees could be involved in providing policies and guidance for clinicians to help ensure equity in the application of rationing under crisis standards of care. An approach guided by egalitarian principles, integrated with utilitarian principles, can support physicians at the bedside when they must ration scarce resources.

Provision of ECPR during COVID-19: evidence, equity, and ethical dilemmas.

The use of extracorporeal cardiopulmonary resuscitation (ECPR) to restore circulation during cardiac arrest is a time-critical, resource-intensive intervention of unproven efficacy. The current COVID-19 pandemic has brought additional complexity and significant barriers to the ongoing provision and implementation of ECPR services. The logistics of patient selection, expedient cannulation, healthcare worker safety, and post-resuscitation care must be weighed against the ethical considerations of providing an intervention of contentious benefit at a time when critical care resources are being overwhelmed by pandemic demand.

Extracorporeal Membrane Oxygenation in Pregnancy: An Analysis of the Extracorporeal Life Support Organization Registry.

OBJECTIVES: We examined data from the International Registry of the Extracorporeal Life Support Organization to identify risk factors for mortality in pregnant and peripartum patients receiving extracorporeal membrane oxygenation. DESIGN: Retrospective analysis. SETTING: International Registry of Extracorporeal Life Support Organization. PATIENTS: We collected de-identified data on all peripartum patients who needed extracorporeal membrane oxygenation between 1997 and 2017 using International Classification of Diseases, 9th and 10th Edition criteria. INTERVENTIONS: Our primary outcome measure was in-hospital mortality. We also collected data on demographics, preextracorporeal membrane oxygenation ventilator, hemodynamic and biochemical parameters, extracorporeal membrane oxygenation mode, duration, and complications. Initial bivariate analysis assessed potential associations between survival and various preextracorporeal membrane oxygenation as well as extracorporeal membrane oxygenation-related factors. Variables with p values of less than 0.1 were considered for logistic regression analysis which identified predictors of mortality. MEASUREMENTS AND MAIN RESULTS: There were 280 peripartum patients who received extracorporeal membrane oxygenation. Overall maternal survival was 70%, with observed mortality for these patients decreasing over the 21-year time period. Multivariate regression identified extracorporeal cardiopulmonary resuscitation (odds ratio, 3.674; 95% CI, 1.425-9.473; overall p = 0.025), duration of extracorporeal membrane oxygenation (< 66 hr: odds ratio, 1; 66-128 hr: odds ratio, 0.281; 95% CI, 0.101-0.777; p = 0.014; 128-232 hr: odds ratio, 0.474; 95% CI, 0.191-1.174; p = 0.107; and > 232 hr: odds ratio, 1.084; 95% CI, 0.429-2.737; p = 0.864; overall p = 0.017), and renal complications on extracorporeal membrane oxygenation (odds ratio, 2.346; 95% CI, 1.203-4.572; p = 0.012) as significant risk factors for mortality. There was no statistically significant difference in mortality between venovenous versus venoarterial versus mixed group extracorporeal membrane oxygenation (23.9 vs 34.4 vs 29.4%; p = 0.2) or between pulmonary versus cardiac indications (1.634; 95% CI, 0.797-3.352; p = 0.18) for extracorporeal membrane oxygenation. CONCLUSIONS: On analysis of this multicenter database, pregnant and peripartum patients with refractory cardiac or respiratory failure supported on extracorporeal membrane oxygenation had survival rates of 70%. We identified preextracorporeal membrane oxygenation as well as extracorporeal membrane oxygenation-related factors that are associated with mortality.

Cost and cost-effectiveness of cardiac surgery in elderly patients.

OBJECTIVE: Cost-effectiveness of heart surgery for elderly patients is still poorly defined. We evaluated outcome, quality of life (QoL), cost, and cost-effectiveness of octogenarians undergoing cardiac surgery. METHODS: One thousand six hundred forty octogenarians undergoing various cardiac surgical procedures were prospectively studied between January 1998 and January 2009 and compared with similar patients aged 70 to 79 years. Several questionnaires were used to assess QoL. Six hundred age- and sex- matched healthy octogenarians and three hundred forty patients older than 80 years with medically treated valvular or coronary artery disease were healthy and unoperated control groups, respectively. In-hospital costs were obtained from the hospital's financial accounting department and cost-effectiveness was estimated and expressed as cost/QoL-adjusted life year (QALY) and cost-effectiveness ratio. RESULTS: Significant improvements occurred in elderly patients in Role Physical (P < .001), Bodily Pain (P < .001), General Health (P = .004), Social Functioning (P < .001), and Role Emotional (P < .001), whereas Physical Functioning, Vitality, and Mental Health did not change (difference not signficant). Total direct costs were $5293 higher in the octogenarian group. Cost-effectiveness was $1391/QALY for elderly surgical patients, $516/QALY for younger cardiac surgical patients (P < .001 vs elderly), $897/QALY for untreated control group, and $641/QALY for healthy control group (P < .001 vs elderly surgical patients). The cost-effectiveness ratio for octogenarians was $94,426. CONCLUSIONS: Our findings confirm that cardiac surgery in elderly patients remains controversial from a cost-effectiveness standpoint, making econometric analysis an important component for any future evaluation of novel cardiovascular therapies. Our findings need to be confirmed by additional multicenter studies.

Assessment of a continuous blood gas monitoring system in animals during circulatory stress.

BACKGROUND: The study was aimed to determine the measurement accuracy of The CDI™ blood parameter monitoring system 500 (Terumo Cardiovascular Systems Corporation, Ann Arbor MI) in the real-time continuous measurement of arterial blood gases under different cardiocirculatory stress conditions METHODS: Inotropic stimulation (Dobutamine 2.5 and 5 µg/kg/min), vasoconstriction (Arginine-vasopressin 4, 8 and 16 IU/h), hemorrhage (-10%, -20%, -35%, and -50% of the theoretical volemia), and volume resuscitation were induced in ten swine (57.4 ± 10.7 Kg).Intermittent blood gas assessments were carried out using a routine gas analyzer at any experimental phase and compared with values obtained at the same time settings during continuous monitoring with CDI™ 500 system. The Bland-Altman analysis was employed. RESULTS: Bias and precision for pO2 were - 0.06 kPa and 0.22 kPa, respectively (r2 = 0.96); pCO2 - 0.02 kPa and 0.15 kPa, respectively; pH -0.001 and 0.01 units, respectively ( r2 = 0.96). The analysis showed very good agreement for SO2 (bias 0.04,precision 0.33, r2 = 0.95), Base excess (bias 0.04,precision 0.28, r2 = 0.98), HCO3 (bias 0.05,precision 0.62, r2 = 0.92),hemoglobin (bias 0.02,precision 0.23, r2 = 0.96) and K+ (bias 0.02, precision 0.27, r2 = 0.93). The sensor was reliable throughout the experiment during hemodynamic variations. CONCLUSIONS: Continuous blood gas analysis with the CDI™ 500 system was reliable and it might represent a new useful tool to accurately and timely monitor gas exchange in critically ill patients. Nonetheless, our findings need to be confirmed by larger studies to prove its reliability in the clinical setting.

Six-minute walking test after cardiac surgery: instructions for an appropriate use.

The 6-min walking test is a practical, simple, inexpensive test, which does not require any exercise equipment or advanced training. The test has been proposed both as a functional status indicator and as an outcome measure in various categories of patients (postmyocardial infarction, heart failure, postcardiac surgery) admitted to rehabilitation programs. The purpose of this study is to review the literature regarding the usefulness of 6-min walking test for the evaluation of patients entering a cardiac rehabilitation program early after cardiac/thoracic surgery. The test is feasible and safe, even in elderly and frail patients, shortly after admission to an in-hospital rehabilitation program. The results of the test is influenced by many demographic and psychological variables, such as age, sex (with women showing lower functional capacity), comorbidity (particularly diabetes mellitus, arthritis, and other musculoskeletal diseases), disability, self-reported physical functioning, and general health perceptions; contrasting data correlate walked distance with left ventricular ejection fraction. Practical suggestions for test execution and results interpretation in this specific clinical setting are given according to current evidence.

Treatment of refractory bleeding after cardiac operations with low-dose recombinant activated factor VII (NovoSeven): a propensity score analysis.

BACKGROUND: Recombinant activated factor VII (rFVIIa) has been increasingly used to stop life-threatening bleeding following cardiac operations. Nonetheless, the issue of dosing, given the expense and potential for thrombotic complications, is still of major concern. We report our experience with small-dose rFVIIa in patients with refractory bleeding after cardiac surgery. METHODS AND RESULTS: From September 2005 to June 2007, 40 patients (mean age 70.1+/-9.2 years, 52.5 males) received a low dose of rFVIIa (median: 18 microg/kg, interquartile range: 9-16 microg/kg) for refractory bleeding after cardiac surgery. Forty propensity score-based greedy matched controls were compared to the study group. Low dose of rFVIIa significantly reduced the 24-h blood loss: 1610 ml [ 1285-1800 ml] versus 3171 ml [2725-3760 ml] in the study and control groups, respectively (p<0.001). Thus, hourly bleeding was 51.1 ml [34.7-65.4 ml] in patients receiving rFVIIa and 196.2 ml/h [142.1-202.9 ml] in controls (p<0.001). Furthermore, patients receiving rFVIIa showed a lower length of stay in the intensive care unit (p<0.001) and shorter mechanical ventilation time (p<0.001). In addition, the use of rFVIIa was associated with reduction of transfusion requirements of red blood cells, fresh frozen plasma and platelets (all, p<0.001). Finally, treated patients showed improved hemostasis with rapid normalization of coagulation variables (partial thromboplastin time, international normalized ratio, platelet count, p<0.001). In contrast, activated prothrombin time and fibrinogen did not differ between groups (p=ns). No thromboembolic-related event was detected in our cohort. CONCLUSIONS: In our experience low-dose rFVIIa was associated with reduced blood loss, improvement of coagulation variables and decreased need for transfusions. Our findings need to be confirmed by further larger studies.