Cost-Effectiveness Analysis of Intravascular Targeted Temperature Management after Cardiac Arrest in England.
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ABSTRACT: Background
Targeted temperature management (TTM) has been shown to improve neurological outcomes and survival in patients resuscitated from cardiac arrest; however, the cost effectiveness of multiple TTM methods is not well studied.Objective
This study aimed to evaluate the cost effectiveness of intravascular temperature management (IVTM) using Thermogard XP compared with surface cooling methods after cardiac arrest in the England from the perspectives of the UK national health service and Personal Social Services.Methods
We developed a multi-state Markov model that evaluated IVTM (Thermogard XP) compared with surface cooling using two different devices (Blanketrol III and Arctic Sun 5000) over a short-term and lifetime time horizon. Model input parameters were obtained from the literature and local databases. We assumed a hypothetical cohort of 1000 patients who required TTM after cardiac arrest per year in the England. The outcomes were costs (in £, year 2019 values) and quality-adjusted life-years (QALYs), discounted at 3.5% annually. Deterministic and probabilistic sensitivity analyses were undertaken to examine the effect of alternative assumptions and uncertainty in model parameters on the results.Results
The cost-effectiveness analysis determined that Thermogard XP resulted in direct cost savings of £2339 and £2925 (per patient) compared with Blanketrol III and Arctic Sun 5000, respectively, and a gain of 0.98 QALYs over the patient lifetime. The probabilistic sensitivity analysis demonstrated that the probability of Thermogard XP being cost saving would be 69.2% and 65.3% versus the Arctic Sun 5000 and Blanketrol III, respectively.Conclusion
Implementation of IVTM using Thermogard XP can lead to cost savings and improved patient quality of life versus surface cooling methods.
SUBMITTER: Javanbakht M
PROVIDER: S-EPMC9283555 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:The aim of this study was to explore the performance and outcomes for intravascular (IC) versus surface cooling devices (SFC) for targeted temperature management (TTM) after out-of-hospital cardiac arrest. METHODS:A retrospective analysis of data from the Time-differentiated Therapeutic Hypothermia (TTH48) trial (NCT01689077), which compared whether TTM at 33?°C for 48?h results in better neurologic outcomes compared with standard 24-h duration. Devices were assessed for the speed of cooling and rewarming rates. Precision was assessed by measuring temperature variability (TV), i.e., the standard deviation (SD) of all temperature measurements in the cooling phase. Main outcomes were overall mortality and poor neurological outcome, including death, severe disability, or vegetative status. RESULTS:A total of 352 patients had available data and were included in the analysis; of those, 218 (62%) were managed with IC. A total of 114/218 (53%) patients with IC and 61/134 (43%) with SFC were cooled for 48?h (p?=?0.22). Time to target temperature (??34?°C) was significantly shorter for patients treated with endovascular devices (2.2 [1.1-4.0] vs. 4.2 [2.7-6.0] h, p?<?0.001), but temperature was also lower on admission (35.0 [34.2-35.6] vs. 35.3 [34.5-35.8]°C; p?=?0.02) and cooling rate was similar (0.4 [0.2-0.8] vs. 0.4 [0.2-0.6]°C/h; p?=?0.14) when compared to SFC. Temperature variability was significantly lower in the endovascular device group when compared with SFC methods (0.6 [0.4-0.9] vs. 0.7 [0.5-1.0]°C; p?=?0.007), as was rewarming rate (0.31 [0.22-0.44] vs. 0.37 [0.29-0.49]°C/hour; p?=?0.02). There was no statistically significant difference in mortality (endovascular 65/218, 29% vs. others 43/134, 32%; p?=?0.72) or poor neurological outcome (endovascular 69/218, 32% vs. others 51/134, 38%; p?=?0.24) between type of devices. CONCLUSIONS:Endovascular cooling devices were more precise than SFC methods in patients cooled at 33?°C after out-of-hospital cardiac arrest. Main outcomes were similar with regard to the cooling methods.
| S-EPMC6385423 | biostudies-literature
Project description:BACKGROUND:Targeted temperature management is recommended after out-of-hospital cardiac arrest and may be achieved using a variety of cooling devices. This study was conducted to explore the performance and outcomes for intravascular versus surface devices for targeted temperature management after out-of-hospital cardiac arrest. METHOD:A retrospective analysis of data from the Targeted Temperature Management trial. N?=?934. A total of 240 patients (26%) managed with intravascular versus 694 (74%) with surface devices. Devices were assessed for speed and precision during the induction, maintenance and rewarming phases in addition to adverse events. All-cause mortality, as well as a composite of poor neurological function or death, as evaluated by the Cerebral Performance Category and modified Rankin scale were analysed. RESULTS:For patients managed at 33 °C there was no difference between intravascular and surface groups in the median time taken to achieve target temperature (210 [interquartile range (IQR) 180] minutes vs. 240 [IQR 180] minutes, p?=?0.58), maximum rate of cooling (1.0 [0.7] vs. 1.0 [0.9] °C/hr, p?=?0.44), the number of patients who reached target temperature (within 4 hours (65% vs. 60%, p?=?0.30); or ever (100% vs. 97%, p?=?0.47), or episodes of overcooling (8% vs. 34%, p?=?0.15). In the maintenance phase, cumulative temperature deviation (median 3.2 [IQR 5.0] °C hr vs. 9.3 [IQR 8.0] °C hr, p?=?<0.001), number of patients ever out of range (57.0% vs. 91.5%, p?=?0.006) and median time out of range (1 [IQR 4.0] hours vs. 8.0 [IQR 9.0] hours, p?=?<0.001) were all significantly greater in the surface group although there was no difference in the occurrence of pyrexia. Adverse events were not different between intravascular and surface groups. There was no statistically significant difference in mortality (intravascular 46.3% vs. surface 50.0%; p?=?0.32), Cerebral Performance Category scale 3-5 (49.0% vs. 54.3%; p?=?0.18) or modified Rankin scale 4-6 (49.0% vs. 53.0%; p?=?0.48). CONCLUSIONS:Intravascular and surface cooling was equally effective during induction of mild hypothermia. However, surface cooling was associated with less precision during the maintenance phase. There was no difference in adverse events, mortality or poor neurological outcomes between patients treated with intravascular and surface cooling devices. TRIAL REGISTRATION:TTM trial ClinicalTrials.gov number https://clinicaltrials.gov/ct2/show/NCT01020916 NCT01020916; 25 November 2009.
| S-EPMC5124238 | biostudies-literature
Project description:BACKGROUND:Targeted temperature management (TTM) of 32 to 34 °C has been the standard treatment for out-of-hospital cardiac arrest since clinical trials in 2002 indicated benefit on survival and neurological outcome. In 2013, a clinical trial showed no difference in outcome between TTM of 33 °C and TTM of 36 °C. In this meta-analysis, we investigate the evidence for TTM in animal models of cardiac arrest. METHODS:We searched PubMed and EMBASE for adult animal studies using TTM as a treatment in different models of cardiac arrest or global brain ischemia which reported neurobehavioural outcome, brain histology or mortality. We used a random effects model to calculate estimates of efficacy and assessed risk of bias using an adapted eight-item version of the Collaborative Approach to Meta-Analysis and Review of Animal Data from Experimental Studies (CAMARADES) quality checklist. We also used a scoring system based on the recommendations of the Stroke Treatment Academic Industry Roundtable (STAIR), to assess the scope of testing in the field. Included studies which investigated a post-ischemic induction of TTM had their treatment regimens characterized with regard to depth, duration and time to treatment and scored against the modified STAIR criteria. RESULTS:The initial and updated search generated 17809 studies after duplicate removal. One hundred eighty-one studies met the inclusion criteria, including data from 1,787, 6,495 and 2,945 animals for neurobehavioural, histological and mortality outcomes, respectively. TTM was favoured compared to control for all outcomes. TTM was beneficial using short and prolonged cooling, deep and moderate temperature reduction, and early and delayed time to treatment. Median [IQR] study quality was 4 [3 to 6]. Eighteen studies checked seven or more of the eight CAMARADES quality items. There was no clear correlation between study quality and efficacy for any outcome. STAIR analysis identified 102 studies investigating post-ischemic induction of TTM, comprising 147 different treatment regimens of TTM. Only 2 and 8 out of 147 regimens investigated comorbid and gyrencephalic animals, respectively. CONCLUSIONS:TTM is beneficial under most experimental conditions in animal models of cardiac arrest or global brain ischemia. However, research on gyrencephalic species and especially comorbid animals is uncommon and a possible translational gap. Also, low study quality suggests risk of bias within studies. Future animal research should focus on mimicking the clinical scenario and employ similar rigour in trial design to that of modern clinical trials.
| S-EPMC6969098 | biostudies-literature
Project description:Targeted temperature management (TTM) is a recommended neuroprotective intervention for coma after out-of-hospital cardiac arrest (OHCA). However, controversies exist concerning the proper implementation and overall efficacy of post-CA TTM, particularly related to optimal timing and depth of TTM and cooling methods. A review of the literature finds that optimizing and individualizing TTM remains an open question requiring further clinical investigation. This paper will summarize the preclinical and clinical trial data to-date, current recommendations, and future directions of this therapy, including new cooling methods under investigation. For now, early induction, maintenance for at least 24 hours, and slow rewarming utilizing endovascular methods may be preferred. Moreover, timely and accurate neuro-prognostication is valuable for guiding ethical and cost-effective management of post-CA coma. Current evidence for early neuro-prognostication after TTM suggests that a combination of initial prediction models, biomarkers, neuroimaging, and electrophysiological methods is the optimal strategy in predicting neurological functional outcomes.
| S-EPMC8142127 | biostudies-literature
Project description:The established benefits of cooling along with development of sophisticated methods to safely and precisely induce, maintain, monitor, and reverse hypothermia have led to the development of targeted temperature management (TTM). Early trials in human subjects showed that hypothermia conferred better neurological outcomes when compared to normothermia among survivors of cardiac arrest, leading to guidelines recommending targeted hypothermia in this patient population. Multiple studies have sought to explore and compare the benefit of hypothermia in various subgroups of patients, such as survivors of out-of-hospital cardiac arrest versus in-hospital cardiac arrest, and survivors of an initial shockable versus non-shockable rhythm. Larger and more recent trials have shown no statistically significant difference in neurological outcomes between patients with targeted hypothermia and targeted normothermia; further, aggressive cooling is associated with a higher incidence of multiple systemic complications. Based on this data, temporal trends have leaned towards using a lenient temperature target in more recent times. Current guidelines recommend selecting and maintaining a constant target temperature between 32 and 36 °C for those patients in whom TTM is used (strong recommendation, moderate-quality evidence), as soon as possible after return of spontaneous circulation is achieved and airway, breathing (including mechanical ventilation), and circulation are stabilized. The comparative benefit of lower (32-34 °C) versus higher (36 °C) temperatures remains unknown, and further research may help elucidate this. Any survivor of cardiac arrest who is comatose (defined as unarousable unresponsiveness to external stimuli) should be considered as a candidate for TTM regardless of the initial presenting rhythm, and the decision to opt for targeted hypothermia versus targeted normothermia should be made on a case-by-case basis.
| S-EPMC9986171 | biostudies-literature
Project description:ObjectiveEvaluate the relationship between heat generation during rewarming in post-cardiac arrest patients receiving targeted temperature management (TTM) as a surrogate of thermoregulatory ability and clinical outcomes.MethodsThis is a prospective observational single-centre study conducted at an urban tertiary-care hospital. We included post-cardiac arrest adults who received TTM via surface cooling device between April 2018 and June 2019.ResultsPatient heat generation was calculated by multiplying the inverse of the average machine water temperature with time to rewarm to 37 °C and standardized in two ways to account for target temperature variation: (1) divided by number of degrees between target temperature and 37 °C, and (2) limited to when patient was rewarmed from 36 °C to 37 °C. The primary outcome was poor neurologic status, defined as Cerebral Performance Category (CPC) score 3-5, and the secondary outcome was 30-day survival. Sixty-six patients were included: 45 (68%) had a CPC-score of 3-5 and 23 (35%) were alive at 30 days. Besides initial rhythm and arrest downtime, baseline characteristics were similar between outcomes. Heat generation was not associated with poor neurological outcome (CPC 3-5: 6.6 [IQR: 6.1, 7.4] versus CPC 1-2: 6.6 [IQR: 5.7, 7.6], p = 0.89) or survival at 30 days (non-survivors: 6.6 [IQR: 6.6, 7.4] vs. survivors: 6.6 [IQR: 5.7, 8.0, p = 0.78]).ConclusionHeat generation during rewarming was not associated with neurologic outcomes. However, there was a relationship between poor neurological outcome and higher median water temperatures. Time to rewarm was prolonged in patients with poor neurological outcome.
| S-EPMC8096702 | biostudies-literature
Project description:BackgroundTargeted temperature management (TTM) has been associated with an improvement in neurological function and survival in patients with cardiac arrest (CA) and an initially shockable rhythm. We report the Montreal Heart Institute (MHI) experience using TTM to evaluate mortality and neurological outcome in patients remaining in coma after CA, regardless of the initial rhythm.MethodsWe performed a retrospective review of all patients receiving TTM at the MHI between 2008 and 2015. Primary outcome was a composite of mortality and poor neurological outcome at hospital discharge. We also evaluated the long-term outcomes of those who initially survived to hospital discharge.ResultsA total of 147 patients (120 men, mean age 59.5 ± 12.5 years) underwent TTM at the MHI during the study period. Overall survival to hospital discharge with good neurological outcome was 45.6%. Shockable rhythm was associated with a better outcome (mortality odds ratio, 0.212; 95% confidence interval, 0.068-0.664; P = 0.008). Of the 11 initial survivors with a poor neurological status (Cerebral Performance Category ≥ 3), 4 died rapidly (within 1 month of hospital discharge), but 6 (54.5%) markedly improved their neurological status to Cerebral Performance Category 1. Long-term survival (mean follow-up of 38 ± 26 months) for those alive at hospital discharge (n = 76 patients) was 81.9%.ConclusionOur retrospective analysis of CA survivors treated with TTM at MHI showed good survival, similar to the published results from the landmark randomized controlled trials, despite enrolling patients with nonshockable rhythms. A significant proportion of survivors with poor neurological outcome at discharge improved at follow-up.
| S-EPMC7063633 | biostudies-literature
Project description:This study aimed to compare prognostic difference between intravascular cooling devices (ICDs) and surface cooling devices (SCDs) in targeted temperature management (TTM) recipients.Adult TTM recipients using ICD or SCD during 2012 to 2016 were included in this nationwide observational study. The outcome was survival to hospital discharge and good neurological outcome at hospital discharge.Among 142,905 out-of-hospital cardiac arrest patients, 1159 patients (SCD, n = 998; ICD, n = 161) were investigated. After propensity score matching for all patients, 161 matched pairs of patients were available for analysis (SCD, n = 161; ICD, n = 161). We observed no significant differences in the survival to hospital discharge (SCD, n = 144 [89.4%] vs ICD, n = 150 [93.2%], P = .32) and the good neurological outcomes (SCD, n = 86 [53.4%] vs ICD, n = 91 [56.5%], P = .65). TTM recipients were categorized by age groups (elderly [age >65 years] vs nonelderly [age ≤65 years]) to compare prognostic difference between ICD and SCD according to the age groups. In the nonelderly group, the use of ICD or SCD was not a significant factor for survival to hospital discharge or good neurologic outcome. Whereas, the use of ICD was significantly associated with good neurological outcome (odds ratio, 3.97; 95% confidence interval, 1.19 - 13.23, P = .02) compared with SCD in the elderly group.There were no significant differences in the survival to hospital discharge and the good neurological outcomes between SCD and ICD recipients. However, the use of ICD might be more beneficial than SCD in elderly patients.
| S-EPMC6709025 | biostudies-literature
Project description:Target temperature management (TTM) in cardiac arrest (CA) survivors is recommended after hospital admission for its possible beneficial effects on survival and neurological outcome. Whether a lower target temperature (i.e., 32-34 °C) improves outcomes is unclear. We conducted a systematic review and meta-analysis on Pubmed and EMBASE to evaluate the effects on mortality and neurologic outcome of TTM at 32-34 °C as compared to controls (patients cared with "actively controlled" or "uncontrolled" normothermia). Results were analyzed via risk ratios (RR) and 95% confidence intervals (CI). Eight randomized controlled trials (RCTs) were included. TTM at 32-34 °C was compared to "actively controlled" normothermia in three RCTs and to "uncontrolled" normothermia in five RCTs. TTM at 32-34 °C does not improve survival as compared to normothermia (RR:1.06 (95%CI 0.94, 1.20), p = 0.36; I2 = 39%). In the subgroup analyses, TTM at 32-34 °C is associated with better survival when compared to "uncontrolled" normothermia (RR: 1.31 (95%CI 1.07, 1.59), p = 0.008) but shows no beneficial effects when compared to "actively controlled" normothermia (RR: 0.97 (95%CI 0.90, 1.04), p = 0.41). TTM at 32-34 °C does not improve neurological outcome as compared to normothermia (RR: 1.17 (95%CI 0.97, 1.41), p = 0.10; I2 = 60%). TTM at 32-34 °C increases the risk of arrhythmias (RR: 1.35 (95%CI 1.16, 1.57), p = 0.0001, I2 = 0%). TTM at 32-34 °C does not improve survival nor neurological outcome after CA and increases the risk of arrhythmias.
| S-EPMC8432025 | biostudies-literature
Project description:BACKGROUND:Targeted temperature management (TTM) with therapeutic hypothermia is an integral component of postarrest care for survivors. However, recent randomized controlled trials (RCTs) have failed to demonstrate the benefit of TTM on clinical outcomes. We sought to determine if the pooled data from available RCTs support the use of prehospital and/or in-hospital TTM after cardiac arrest. METHODS:A comprehensive search of SCOPUS, Elsevier's abstract and citation database of peer-reviewed literature, from 1966 to November 2016 was performed using predefined criteria. Therapeutic hypothermia was defined as any strategy that aimed to cool post-cardiac arrest survivors to a temperature ≤34°C. Normothermia was temperature of ≥36°C. We compared mortality and neurologic outcomes in patients by categorizing the studies into 2 groups: (1) hypothermia versus normothermia and (2) prehospital hypothermia versus in-hospital hypothermia using standard meta-analytic methods. A random effects modeling was utilized to estimate comparative risk ratios (RR) and 95% confidence intervals (CIs). RESULTS:The hypothermia and normothermia strategies were compared in 5 RCTs with 1389 patients, whereas prehospital hypothermia and in-hospital hypothermia were compared in 6 RCTs with 3393 patients. We observed no difference in mortality (RR, 0.88; 95% CI, 0.73-1.05) or neurologic outcomes (RR, 1.26; 95% CI, 0.92-1.72) between the hypothermia and normothermia strategies. Similarly, no difference was observed in mortality (RR, 1.00; 95% CI, 0.97-1.03) or neurologic outcome (RR, 0.96; 95% CI, 0.85-1.08) between the prehospital hypothermia versus in-hospital hypothermia strategies. CONCLUSIONS:Our results suggest that TTM with therapeutic hypothermia may not improve mortality or neurologic outcomes in postarrest survivors. Using therapeutic hypothermia as a standard of care strategy of postarrest care in survivors may need to be reevaluated.
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