Clinical effectiveness and cost-effectiveness of implantable cardioverter defibrillators for arrhythmias: A systematic review and economic evaluation

Author(s):  
Jackie Bryant ◽  
Hakan Brodin ◽  
Emma Loveman ◽  
Andrew Clegg

Objectives:The clinical effectiveness and cost-effectiveness of implantable cardioverter defibrillators (ICD) for arrhythmias was assessed.Methods:A systematic review of the literature of systematic reviews and randomized controlled trials that reported mortality outcomes associated with implantable cardioverter defibrillators compared with antiarrhythmic drug therapy in people at risk of sudden cardiac death due to arrhythmias was undertaken. Economic evaluations were also sought. Inclusion criteria, data extraction, and quality assessment were undertaken by standard methodology. A decision analytic model was constructed using best available evidence to determine cost-effectiveness in a UK setting.Results:Eight randomized controlled trials, two systematic reviews, and a meta-analysis met the inclusion criteria and were of variable quality. Evidence suggests that ICDs reduce mortality in both secondary and primary prevention, although the magnitude of benefit depends on baseline risk for sudden cardiac death. Incremental cost per quality-adjusted life year ranged from £52,000 ($98,000) to over £200,000 ($379,000), depending on mortality risk and assumptions made.Conclusions:Evidence suggests that ICDs reduce total mortality but may be cost-effective only in some subgroups of patients at high risk of ventricular arrhythmias. Further research is needed on risk stratification of patients in whom ICDs are most likely to be clinically and cost-effective.

EP Europace ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. 1071-1082 ◽  
Author(s):  
Saannya Sequeira ◽  
Christopher I Jarvis ◽  
Akram Benchouche ◽  
Jerome Seymour ◽  
Abir Tadmouri

Abstract Aims Cost-effectiveness data on the remote monitoring (RM) of implantable cardioverter-defibrillators (ICDs) compared to the current standard of care (SC) remains limited. This meta-analysis was performed to assess the economic burden, and to develop an integrated economic model evaluating the efficiency of the RM strategy vs. SC in the context of French healthcare. Methods and results Randomized controlled trials, comparing RM to SC in patients implanted with ICDs with or without resynchronization therapy (±CRT-D), were identified through a systematic search of scientific literature databases dating from 2005. Seventeen trials (10 229 patients) reporting data on clinical outcomes, quality of life, cost, and/or utility, either as primary or secondary endpoints were identified. Compared to SC, RM resulted in significant reductions in annual costs per patient for direct healthcare costs (seven studies, difference in means −276.1, 95% standard error [SE]: 66.0, I2 = 76.3%) and for labour costs (two studies, difference in means −11.3, 95% SE: 1.4, I2 = 96.3%). A three-state Markov Model showed that RM resulted in cost-savings of €4142 per patient over a 5-year time horizon, with a quality-adjusted life year (QALY) gain of 0.29. The incremental cost-effectiveness ratio was −14 136 €/QALY, in favour of RM. Furthermore, probabilistic sensitivity analyses confirmed that the RM strategy was dominant over SC in 70% of cases. Conclusion Our economic model demonstrates that once implemented, RM of ICD ± CRT-D patients would result in increased effectiveness for lower costs over a 5-year period, compared to the current SC in France.


2020 ◽  
Vol 1 (1) ◽  
pp. 20-29
Author(s):  
Martijn Scherrenberg ◽  
Maarten Falter ◽  
Paul Dendale

Abstract This systematic review aims to assess the cost-effectiveness of cardiac telerehabilitation in comparison with centre-based cardiac rehabilitation (CR). Evidence of cost-effectiveness is an important step towards implementation and reimbursement of telerehabilitation services. Electronic databases were searched for economic evaluations of telerehabilitation programmes. Only randomized controlled trials (RCTs) published in English were eligible for inclusion. Study quality and risk of bias were assessed using the Consensus Health Economic Criteria (CHEC) list. A total of eight economic evaluations met the review inclusion criteria. The total sample size consisted of 751 patients ranging from a minimum of 46 patients to a maximum of 162 patients per study. Maximal follow-up was 5 years. A total of seven of the eight included studies demonstrated that telerehabilitation could lead to similar or lower long-term costs and are thus as cost-effective as traditional centre-based CR. There is significant heterogeneity between all included telerehabilitation interventions in duration, used technology, cost included and follow-up. Based on these small short duration trials, telerehabilitation may be as cost-effective as traditional centre-based approaches. However, more assessments of the value for money of telerehabilitation in larger and longer RCTs are needed both in high- as low-income countries.


2021 ◽  
pp. 107815522199254
Author(s):  
Jacopo Giuliani ◽  
Francesco Fiorica ◽  
Giovanni Ponturo ◽  
Maurizio Azzurro ◽  
Andrea Ruzzenente ◽  
...  

The analysis was conducted to assess the pharmacological costs of regorafenib and trifluridine/tipiracil in the treatment of refractory metastatic colorectal cancer (mCRC). Pivotal phase III randomized controlled trials (RCTs) of regorafenib and trifluridine/tipiracil in the treatment of refractory mCRC were considered. We have also considered the ReDOS trial, in order to verify if the dose-escalation strategy (practice changing for regorafenib) could influences the results. Differences in OS (expressed in months) between the different arms were calculated and compared with the pharmacological costs (at the Pharmacy of our Hospital and expressed in euros (€)) needed to get one month of OS. Trifluridine/tipiracil resulted the less expensive, with 1167.50 €per month OS-gained. The ReDOS trial further reduce costs with 510.41 €per month OS-gained in favour of regorafenib with the escalation-dose strategy. Both regorafenib and trifluridine/tipiracil can be considered economically sustainable treatments for refractory mCRC, apparently with a lower cost of trifluridine/tipiracil. The adoption of a dose-escalation strategy (ReDOS trial) could reverse the situation making regorafenib more cost-effective than trifluridine/tipiracil.


2017 ◽  
Vol 5 (17) ◽  
pp. 1-406 ◽  
Author(s):  
Gavin J Murphy ◽  
Andrew D Mumford ◽  
Chris A Rogers ◽  
Sarah Wordsworth ◽  
Elizabeth A Stokes ◽  
...  

BackgroundAnaemia, coagulopathic bleeding and transfusion are strongly associated with organ failure, sepsis and death following cardiac surgery.ObjectiveTo evaluate the clinical effectiveness and cost-effectiveness of medical devices used as diagnostic and therapeutic tools for the management of anaemia and bleeding in cardiac surgery.Methods and resultsWorkstream 1 – in the COagulation and Platelet laboratory Testing in Cardiac surgery (COPTIC) study we demonstrated that risk assessment using baseline clinical factors predicted bleeding with a high degree of accuracy. The results from point-of-care (POC) platelet aggregometry or viscoelastometry tests or an expanded range of laboratory reference tests for coagulopathy did not improve predictive accuracy beyond that achieved with the clinical risk score alone. The routine use of POC tests was not cost-effective. A systematic review concluded that POC-based algorithms are not clinically effective. We developed two new clinical risk prediction scores for transfusion and bleeding that are available as e-calculators. Workstream 2 – in the PAtient-SPecific Oxygen monitoring to Reduce blood Transfusion during heart surgery (PASPORT) trial and a systematic review we demonstrated that personalised near-infrared spectroscopy-based algorithms for the optimisation of tissue oxygenation, or as indicators for red cell transfusion, were neither clinically effective nor cost-effective. Workstream 3 – in the REDWASH trial we failed to demonstrate a reduction in inflammation or organ injury in recipients of mechanically washed red cells compared with standard (unwashed) red cells.LimitationsExisting studies evaluating the predictive accuracy or effectiveness of POC tests of coagulopathy or near-infrared spectroscopy were at high risk of bias. Interventions that alter red cell transfusion exposure, a common surrogate outcome in most trials, were not found to be clinically effective.ConclusionsA systematic assessment of devices in clinical use as blood management adjuncts in cardiac surgery did not demonstrate clinical effectiveness or cost-effectiveness. The contribution of anaemia and coagulopathy to adverse clinical outcomes following cardiac surgery remains poorly understood. Further research to define the pathogenesis of these conditions may lead to more accurate diagnoses, more effective treatments and potentially improved clinical outcomes.Study registrationCurrent Controlled Trials ISRCTN20778544 (COPTIC study) and PROSPERO CRD42016033831 (systematic review) (workstream 1); Current Controlled Trials ISRCTN23557269 (PASPORT trial) and PROSPERO CRD4201502769 (systematic review) (workstream 2); and Current Controlled Trials ISRCTN27076315 (REDWASH trial) (workstream 3).FundingThis project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full inProgramme Grants for Applied Research; Vol. 5, No. 17. See the NIHR Journals Library website for further project information.


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