Ontario health technology assessment series
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Ont Health Technol Assess Ser · Jan 2020
Meta AnalysisTranscatheter Aortic Valve Implantation in Patients With Severe Aortic Valve Stenosis at Low Surgical Risk: A Health Technology Assessment.
Surgical aortic valve replacement (SAVR) is the conventional treatment for patients with severe aortic valve stenosis at low surgical risk. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure. We conducted a health technology assessment (HTA) of TAVI for patients with severe aortic valve stenosis at low surgical risk, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding TAVI, and patient preferences and values. ⋯ Both TAVI (transfemoral route) and SAVR resulted in improved patient symptoms and quality of life during the 1 year of follow-up. The TAVI procedure is less invasive and resulted in greater symptom improvement and quality of life than SAVR 30 days after surgery. The TAVI procedure also resulted in a small improvement in mortality and disabling stroke at 30 days. At 1 year, TAVI and SAVR were similar with regard to mortality, although TAVI may result in a slightly lower risk of disabling stroke. According to the study authors, longer follow-up is needed to better understand how long TAVI valves last and to draw definitive conclusions on the long-term outcomes of TAVI compared with SAVR beyond 1 year.The TAVI procedure might be cost-effective for patients at low surgical risk; however, there is some uncertainty in this result. We estimated that the additional cost to provide public funding for TAVI in people with severe aortic valve stenosis at low surgical risk would range from about $5 million to $8 million over the next 5 years.Among a mixed or generally high-risk population, people typically preferred the less invasive nature and the faster recovery time of TAVI compared with SAVR.
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Ont Health Technol Assess Ser · Jan 2020
Transcatheter Aortic Valve Implantation in Patients With Severe, Symptomatic Aortic Valve Stenosis at Intermediate Surgical Risk: A Health Technology Assessment.
Surgical aortic valve replacement (SAVR) is the conventional treatment in patients at low or intermediate surgical risk. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure, originally developed as an alternative for patients at high or prohibitive surgical risk. ⋯ In people with severe, symptomatic aortic valve stenosis at intermediate surgical risk, TAVI was similar to SAVR with respect to the composite endpoint of all-cause mortality or disabling stroke. However, the two treatments had different patterns of complications. The study authors also noted that longer follow-up is needed to assess the durability of the TAVI valve. Compared with SAVR, TAVI may provide good value for money, but publicly funding TAVI in Ontario would result in additional costs over the next 5 years. People with aortic valve stenosis who had undergone TAVI appreciated its less invasive nature and reported a substantial reduction in physical and psychological effects after the procedure, improving their quality of life.
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Ont Health Technol Assess Ser · Jan 2020
5-Aminolevulinic Acid Hydrochloride (5-ALA)-Guided Surgical Resection of High-Grade Gliomas: A Health Technology Assessment.
High-grade gliomas are a type of malignant brain tumour. Optimal management often includes maximal surgical resection. 5-aminolevulinic acid hydrochloride (5-ALA) is an imaging agent that makes a high-grade glioma fluoresce under blue light, which can help guide the surgeon when removing the tumour. We conducted a health technology assessment of 5-ALA-guided surgical resection of high-grade gliomas, which included an evaluation of effectiveness, safety, the budget impact of publicly funding 5-ALA, and patient preferences and values. ⋯ 5-ALA-guided surgical resection appears to improve the extent of resection of high-grade gliomas compared with surgery using standard white-light microscopy (GRADE: Low). The evidence suggests 5-ALA-guided resection may improve overall survival; however, we cannot exclude the possibility of no effect (Grade: Low). 5-ALA may improve 6-month progression-free survival, although the results are highly uncertain (GRADE: Very low). There is an uncertain impact on overall or neurological adverse events (GRADE: Very low). We did not identify any economic studies conducted from the perspective of the Ontario or Canadian public health care payer. Of the studies that met our inclusion criteria, most found 5-ALA-guided surgical resection was cost-effective compared to white-light microscopy for high-grade gliomas. However, clinical model inputs for the comparative effectiveness and safety of 5-ALA were based on limited and low-quality evidence. We estimate that publicly funding 5-ALA-guided surgical resection in Ontario over the next 5 years would result in a total 5-year budget impact of about $7,500,000. For people diagnosed with high-grade gliomas, 5-ALA is seen positively as a useful imaging tool for brain tumour resection.
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Ont Health Technol Assess Ser · Jan 2020
10-kHz High-Frequency Spinal Cord Stimulation for Adults With Chronic Noncancer Pain: A Health Technology Assessment.
Chronic pain is costly for patients and for the health care system. It negatively affects people's physical, emotional, social, and mental health. We conducted a health technology assessment of 10-kHz high-frequency spinal cord stimulation (SCS) in adults with chronic noncancer pain that was refractory to medical management, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding 10-kHz high-frequency SCS, and patient preferences and values. ⋯ For adults with chronic noncancer pain that was refractory to medical management, 10-kHz high-frequency SCS was effective in relieving pain, reducing disability, and improving quality of life. Because there was limited evidence about the effectiveness of 10-kHz high-frequency SCS in people who had first tried and failed SCS at lower frequencies (up to 1.2 kHz), we were unable to determine whether 10-kHz high-frequency SCS is cost-effective in the Ontario context. We estimate that publicly funding 10-kHz high-frequency SCS in Ontario would result in cost savings of about $0.10 million to $0.21 million per year, for a potential total 5-year net cost savings of about $0.73 million. Although people with chronic noncancer pain knew little about SCS before they received it, they reported that it reduced their level of chronic pain, leading to improvements in function and their ability to perform activities of daily living.
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Ont Health Technol Assess Ser · Jan 2020
Portable Normothermic Cardiac Perfusion System in Donation After Cardiocirculatory Death: A Health Technology Assessment.
Heart transplantation is the most effective treatment for people experiencing end-stage heart failure whose quality of life and life expectancy are unacceptable. However, there is a chronic shortage of donor hearts to meet the demand, so it is essential to expand the donor pool and increase supply. Heart donation mainly occurs after brain death (neurological determination of death [NDD]), but it may also be feasible after cardiocirculatory death (when the heart has stopped beating and there is no longer blood flow or a pulse), provided specialized preservation techniques are used. An investigational device, a portable normothermic cardiac perfusion system, could make it possible to procure, preserve, and transport hearts donated after cardiocirculatory death (DCD). We conducted a health technology assessment of a portable normothermic cardiac perfusion system for the preservation and transportation of DCD hearts for adult transplantation. This included an evaluation of the effectiveness, safety, value for money, and budget impact of publicly funding this system, as well as an evaluation of patient preferences and values. ⋯ Based on very low quality of evidence, the outcomes for recipients of DCD hearts preserved using a portable normothermic cardiac perfusion system appear to be similar to outcomes for recipients of NDD hearts. Owing to a lack of evidence relevant to the Ontario context, we were unable to determine whether a portable normothermic perfusion system may be cost-effective. We estimate that publicly funding a portable normothermic cardiac perfusion system for DCD heart transplantation over the next 5 years will cost about $5.6 million. The people we spoke with believe that the system may increase the number of hearts available for transplant and therefore increase the number of heart transplants that can be done.