Assessment of economic effectiveness in treatment of neuropathic pain and refractory angina pectoris using spinal cord stimulation.

BACKGROUND: The implementation of new diagnostic and therapeutic technologies is related to expanding financial needs. The escalation of expenses for health protection and simultaneous economic problems has resulted in an interest in the subject of economic assessment. Decision makers in the health sector should have reasonable tools that will allow them to make complex evaluations of the economic suitability of health technologies. Economic analysis should also prove that launching new procedures can save money. Numerous studies indicate that chronic pain and psycho-sociological variables lead to a worse quality of life. Chronic pain issues are a major public health problem, by virtue of the difficulties in efficient therapy and the social costs reflected in incapability of work and disability. Spinal cord stimulation is the most efficacious procedure in the treatment of chronic pain. OBJECTIVES: The aim of the study was to estimate the costs of treatment of 37 patients suffering from refractory angina pectoris and neuropathic pain who underwent SCS surgery between 2002 and 2008 in the Neurosurgery Clinic of the 10th Military Hospital in Bydgoszcz in the period of two years before and two years after spinal cord stimulation. The authors also assessed quality of life, using the SF 36 questionnaire, and degree of pain using VAS. MATERIAL AND METHODS: The issue was examined with a cost-benefit analysis. Cost was understood as the expenses made two years before and two years after the SCS procedure. The benefits were health care expenses saved by implementation of the SCS procedure. All the costs included in both alternative treatment techniques in a period of 5 years underwent a discounting procedure. The authors also included the price of the neurostimulator under a sensitivity analysis. To assess the quality of life before and after the SCS procedure, a SF 36 questionnaire was used, and to assess the level of pain before and after the SCS procedure, the VAS scale. RESULTS: The costs of treatment of refractory angina pectoris and neuropathic pain are lower when using spinal cord stimulation. In the case of refractory angina pectoris, savings reached 46% whereas in the case of neuropathic pain, 13.2%. The costs of the purchase of the device returned in three years for angina pectoris and seven years for neuropathic pain. SCS in both cases brought a reduction of the level of pain and an improvement to quality of life. CONCLUSIONS: SCS in both neuropathic pain and refractory angina pectoris is a procedure that brings benefits in the form of savings. After using SCS in both cases, the quality of life improved and the level of pain was reduced.

Resource utilization implications of treatment were able to be assessed from appropriately reported clinical trial data.

BACKGROUND AND OBJECTIVE: Published clinical trial data rarely allow assessment of the health care resource utilization implications of treatment. We give an example of how these can be assessed given appropriate tabulation of data. METHODS: Data from a trial comparing long-acting nifedipine gastrointestinal therapeutic system to placebo in 7,665 patients with stable angina pectoris was analyzed. RESULTS: Relative to placebo, nifedipine significantly increased mean cardiovascular (CV) event-free survival by 41 days but had no effect on mean survival. Per 100 years of follow-up, 78.1 patient-years of double-blind nifedipine administration reduced use of another calcium antagonist, an angiotensin converting enzyme inhibitor, an angiotensin receptor blocker, a diuretic and a cardiac glycoside by 1.54, 3.73, 2.63, 2.23, and 0.64 years, respectively, whereas 0.21 less hospitalization for overt heart failure, 0.47 less hospitalization for any stroke or transient ischemic attack, 0.8 less coronary angiogram, 0.38 less coronary bypass procedure, and 0.13 additional orthopedic procedure was required. Combining resource utilization with cost data for one particular hospital showed that one additional year of CV event-free survival costs an average additional euro 3,036 in the setting considered. CONCLUSION: Appropriately tabulated clinical trial data allows clinicians to judge the resource utilization implications and economic effect of treatment decisions.

[Importance of spinal cord stimulation in the treatment of refractory angina]. / Il ruolo della stimolazione spinale nel trattamento dell'angina refrattaria.

A small non-quantified number of patients is reported to be affected by forms of angina pectoris already treated by traditional therapy but no longer able to achieve better results by drugs or surgery: this is called "refractory angina". Treatments like external counterpulsation, transmyocardial laser revascularization, stem cell transplantation or spinal cord stimulation may be suitable for these patients. The analysis of major studies on spinal cord stimulation based on exercise ECG, Holter monitoring and positron emission tomography, has shown a reduction in anginal attacks and in nitroglycerin pills. Though in small figures, an improved perfusion of the ischemic areas, an increase in the time of ischemia and cardiac mortality comparable to bypass surgery as well as a better quality of life and lower costs with respect to traditional treatment are also evident. Patients who are at high risk of mortality for bypass surgery, and who cannot receive significant benefits from revascularization or improved pharmacological therapy are candidate to spinal cord stimulation. Spinal cord stimulation is safe and effective in about 70% of patients. Some issues have not been investigated yet: the clinical characteristics of "non-responders" and the possibility of avoiding sudden cardiac death in stimulated patients.

Spinal cord stimulation for refractory angina pectoris: a retrospective analysis of efficacy and cost-benefit.

BACKGROUND: Patients with refractory angina pectoris have severe symptoms despite optimal medication, but are not suitable for revascularisation. Spinal cord stimulation (SCS) has been used for treating refractory angina pectoris since 1985. The efficacy of SCS has been proven by randomised controlled trials and follow-up studies have shown that SCS is a safe treatment. The objective of the current study was to retrospectively analyse the clinical outcomes and cost-benefit of SCS in patients with refractory angina pectoris. METHODS: Eighteen months after SCS implantation, the effects on Canadian Cardiovascular Society (CCS) functional level and acute symptom relief of 24 patients with permanent SCS were analysed by review of medical records. Nineteen of these 24 patients were able to report their anginal frequency, nitroglycerin consumption and subjective perception on physical activity and quality of life. RESULTS: Angina frequency decreased from a median of 14.0 to 2.3 attacks/week (p < 0.01). Nitroglycerin intake decreased from a median of 27.5 to 1.5 doses/week (p < 0.01). Canadian Cardiovascular Society angina class improved from a median of three to two (p < 0.001). During a three-year period before SCS implantation, the hospitalisation rate and duration related to coronary artery disease increased progressively. The duration of hospitalisation increased from a median of three to 10 days/patient/year. In the year after SCS implantation the duration of hospitalisation decreased to a median of 0 day/patient/year (p < 0.001). The cost of hospital care due to coronary artery disease decreased significantly thereafter. The total cost of SCS procedure was recovered within 16 months after implantation, which is less than 40% of the device life span. CONCLUSIONS: This retrospective study indicates that SCS treatment alleviates angina symptoms and improves quality of life. The treatment is also effective in preventing hospitalisations and saving costs in hospital care. A prospective study is warranted to confirm the current observations.

Long-term effects of integrated rehabilitation in patients with advanced angina pectoris: a nonrandomized comparative study.

OBJECTIVES: An evaluation of Integrative Rehabilitation (IR) of patients with angina pectoris with respect to death rate, the need for invasive treatment, and cost effectiveness. DESIGN: A report from a clinical database. Death rates were compared to those of the general Danish population matched for age, gender, and observation period, as well as with data from the literature concerning medical and invasive treatments. SETTING: The treatment was carried out as an ambulatory treatment in a private clinic. SUBJECTS: One hundred and sixty-eight (168) patients with angina pectoris, of whom 103 were candidates for invasive treatment and 65 for whom this had been rejected. INTERVENTIONS: Integrated rehabilitation consists of acupuncture, a self-care program including acupressure, Chinese health philosophy, stress management techniques, and lifestyle adjustments. OUTCOME MEASURES: Death rate from any cause, the need for invasive treatment, and health care expenses. RESULTS: The 3-year accumulated risk of death was 2.0% (95% confidence limits: 0.0%-4.7%) for the 103 candidates for invasive treatment, 6.4% for the general Danish population, 5.4% (4.7%-6.1%), and 8.4% (7.7%-9.1%) for patients who underwent percutaneous transluminal balloon angioplasty and coronary artery bypass grafting, respectively, in New York. For the 65 inoperable patients the risk of death due to heart disease was 7.7% (3.9%-11.5%), compared to 16% (10%-34%) and 25% (18%-36%) for American patients, who were treated with laser revascularization or medication, respectively. Of the 103 candidates for invasive treatment, only 19 (18%) still required surgery. Cost savings over 3 years were US 36,000 dollars and US 22,000 dollars for surgical and nonsurgical patients, respectively. These were mainly achieved by the reduction in the use of invasive treatment and a 95% reduction in in-hospital days. CONCLUSIONS: Integrated rehabilitation was found to be cost effective, and added years to the lives of patients with severe angina pectoris. The results invite further testing in a randomized trial.

Cost-effectiveness of spinal cord stimulation in patients with intractable angina.

AIM: To review the cost of healthcare utilisation by patients suffering from intractable angina, unsuitable for coronary revascularisation, before and after treatment with spinal cord stimulation. METHODS: Data were collected for eight patients treated for intractable angina with spinal cord stimulation at Green Lane Hospital before April 1999. Information on consumption of specified medica resources for the twelve months preceding implantation, the implantation period, and the twelve months following implantation was collected. Where available, data were also collected for the eighteen months preceding and following treatment. RESULTS: In six patients successful permanent stimulation was established; in two it proved technically impossible to implant a stimulator. The six patients with successful stimulation spent fewer days in hospital (p=0.028) and consumed fewer resources (p=0.046) following implantation than in the period before implantation. The two patients for whom spinal cord stimulation was unsuccessful spent more days in hospital and consumed more resources in the twelve months following, than in the twelve months preceding attempted implantation. Extrapolation of data for all eight patients suggests that, on average, the cost of implanting a spinal cord stimulator will be recovered in approximately fifteen months. CONCLUSION: Spinal cord stimulation is a cost-effective treatment for intractable angina pectoris.

[Cost-benefit analysis of electric stimulation of the spinal cord in the treatment of angina pectoris]. / Cost-utility analyse af elektrisk rygmarvsstimulation til behandling af angina pectoris.

Since August 1988, in Odense Hospital, electric spinal cord stimulation (SCS) has been employed for the treatment of pain in patients with confirmed ischaemic heart disease who suffer from incapacitating angina pectoris despite maximal medical/surgical treatment. The object of the present investigation was to assess not only the social economic consequences of SCS treatment (cost-utility analysis) but also altered quality of life in SCS patients (perception of pain, mobility, function in daily life and physical activity). Sixteen consecutive SCS patients all of whom were resident in the County of Funen and who were submitted to implantation of an SCS system during the period August 1988 to December 1989, participated in this investigation. The results are based on data from the year prior to SCS implantation compared with the subsequent time with SCS treatment. Saving was found at hospital level (reduction in number of admissions) og 40,200 Danish crowns/annum/patient (approximately IJ 3,000) (1989 prices), and for non-hospital related expenses a corresponding saving of 16,289 Danish crowns/annum/patient (approximately IJ 1,600) was found mainly on account of reduction in the amount of home nursing required. The total saving was found to constitute 56,489 Danish crowns/annum/patient (approximately IJ 5,600). In addition, improvements were registered in all respects which constituted assessment of the quality of life of the patients.

[Randomized, double-blind comparison of isosorbide-5-mononitrate and delayed-action nifedipine in patients with stable exertional angina. Multicenter Study Group]. / Randomisierter, doppelblinder Vergleich von Isosorbid-5-Mononitrat und retardiertem Nifedipin bei Patienten mit stabiler Belastungsangina. Multicenter Studien-Gruppe.

The therapeutic effects of IS-5-MN and s.r. nifedipine were investigated in this double-blind, randomized, group-comparative, multicenter study over 2 weeks, in 251 patients with stable reproducible exercise-induced angina. After 2 weeks' treatment with IS-5-MN 20 mg b.i.d. or t.i.d., 61% of the patients were responders who showed an increase in total exercise time (to moderately severe angina) of greater than or equal to 20% in comparison with placebo in the run-in phase. The corresponding responder rate after s.r. nifedipine 20 mg b.i.d. or 40 mg b.i.d. was 53%. Both IS-5-MN and s.r. nifedipine significantly increased the total exercise time, the time to angina onset and to greater than or equal to 1 mm ST-depression, and significantly reduced the rate pressure product and the ST-segment depression at peak exercise in comparison with placebo in the run-in phase. The improvement in quality of life as indicated by the reduction in anginal episodes and intake of short-acting nitrates was comparable with both drugs. The pattern and incidence of all AEs were as expected in the two active treatment groups. The daily treatment costs for a 20 mg b.i.d. dosing regimen for both drugs in the Federal Republic of Germany was 64% higher for s.r. nifedipine than with IS-5-MN.