Ontario health technology assessment series
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Ont Health Technol Assess Ser · Jan 2006
Coil embolization for intracranial aneurysms: an evidence-based analysis.
To determine the effectiveness and cost-effectiveness of coil embolization compared with surgical clipping to treat intracranial aneurysms. ⋯ SAFETY AND EFFECTIVENESS: Coil embolization appears to be a safe procedure. Complications associated with coil embolization ranged from 8.6% to 18.6% with a median of about 10.6%. Observational studies showed that coil embolization is associated with lower complication rates than surgical clipping (permanent complication 3-7% versus 10.9%; overall 23% versus 46% respectively, p=0.009). Common complications of coil embolization are thrombo-embolic events (2.5%-14.5%), perforation of aneurysm (2.3%-4.7%), parent artery obstruction (2%-3%), collapsed coils (8%), coil malposition (14.6%), and coil migration (0.5%-3%). Randomized controlled trials showed that for ruptured intracranial aneurysms with SAH, suitable for both coil embolization and surgical clipping (mostly saccular aneurysms <10 mm in diameter located in the anterior circulation) in people with good clinical condition:Coil embolization resulted in a statistically significant 23.9% relative risk reduction and 7% absolute risk reduction in the composite rate of death and dependency compared to surgical clipping (modified Rankin score 3-6) at 1-year. The advantage of coil embolization over surgical clipping varies widely with aneurysm location, but endovascular treatment seems beneficial for all sites. There were less deaths in the first 7 years following coil embolization compared to surgical clipping (10.8% vs 13.7%). This survival benefit seemed to be consistent over time, and was statistically significant (log-rank p= 0.03). Coil embolization is associated with less frequent MRI-detected superficial brain deficits and ischemic lesions at 1-year. The 1- year rebleeding rate was 2.4% after coil embolization and 1% for surgical clipping. Confirmed rebleeding from the repaired aneurysm after the first year and up to year eight was low and not significantly different between coil embolization and surgical clipping (7 patients for coil embolization vs 2 patients for surgical clipping, log-rank p=0.22). Observational studies showed that patients with SAH and good clinical grade had better 6-month outcomes and lower risk of symptomatic cerebral vasospasm after coil embolization compared to surgical clipping. For unruptured intracranial aneurysms, there were no randomized controlled trials that compared coil embolization to surgical clipping. Large observational studies showed that: The risk of rupture in unruptured aneurysms less than 10 mm in diameter is about 0.05% per year for patients with no pervious history of SAH from another aneurysm. The risk of rupture increases with history of SAH and as the diameter of the aneurysm reaches 10 mm or more. Coil embolization reduced the composite rate of in hospital deaths and discharge to long-term or short-term care facilities compared to surgical clipping (Odds Ratio 2.2, 95% CI 1.6-3.1, p<0.001). The improvement in discharge disposition was highest in people older than 65 years. In-hospital mortality rate following treatment of intracranial aneurysm ranged from 0.5% to 1.7% for coil embolization and from 2.1% to 3.5% for surgical clipping. The overall 1-year mortality rate was 3.1% for coil embolization and 2.3% for surgical clipping. One-year morbidity rate was 6.4% for coil embolization and 9.8% for surgical clipping. It is not clear whether these differences were statistically significant. Coil embolization is associated with shorter hospital stay compared to surgical clipping. For both ruptured and unruptured aneurysms, the outcome of coil embolization does not appear to be dependent on age, whereas surgical clipping has been shown to yield worse outcome for patients older than 64 years. ANGIOGRAPHIC EFFICIENCY AND RECURRENCES: The main drawback of coil embolization is its low angiographic efficiency. The percentage of complete aneurysm occlusion after coil embolization (27%-79%, median 55%) remains lower than that achieved with surgical clipping (82%-100%). However, about 90% of coiled aneurysms achieve near total occlusion or better. Incompletely coiled aneurysms have been shown to have higher aneurysm recurrence rates ranging from 7% to 39% for coil embolization compared to 2.9% for surgical clipping. Recurrence is defined as refilling of the neck, sac, or dome of a successfully treated aneurysm as shown on an angiogram. The long-term clinical significance of incomplete occlusion following coil embolization is unknown, but in one case series, 20% of patients had major recurrences, and 50% of these required further treatment. LONG-TERM OUTCOMES: A large international randomized trial reported that the survival benefit from coil embolization was sustained for at least 7 years. The rebleeding rate between year 2 and year 8 following coil embolization was low and not significantly different from that of surgical clipping. However, high quality long-term angiographic evidence is lacking. Accordingly, there is uncertainty about long-term occlusion status, coil durability, and recurrence rates. While surgical clipping is associated with higher immediate procedural risks, its long-term effectiveness has been established. INDICATIONS AND CONTRAINDICATIONS: Coil embolization offers treatment for people at increased risk for craniotomy, such as those over 65 years of age, with poor clinical status, or with comorbid conditions. The technology also makes it possible to treat surgical high-risk aneurysms. Not all aneurysms are suitable for coil embolization. (ABSTRACT TRUNCATED)
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Ont Health Technol Assess Ser · Jan 2006
Enhanced External Counterpulsation (EECP): An Evidence-Based Analysis.
To assess the effectiveness, and cost effectiveness of EECP in patients with severe anginal symptoms, secondary to chronic coronary disease, who are unresponsive to exhaustive pharmacotherapy and not candidates for surgical/percutaneous revascularization procedures (e.g., angioplasty, coronary bypass surgery). To assess the effectiveness, and cost effectiveness of EECP in patients with heart failure. ⋯ The Cochrane and INAHTA databases yielded 3 HTAs or systematic reviews on EECP treatment (Blue Cross Blue Shield Technology Evaluation Center [BCBS TEC], ECRI, and the Centers for Medicare and Medicaid Services [CMS]). A search of Medline and Embase December 2005 - March 2006 (after the literature search cutoff from the most recent HTA) was conducted using key words enhanced external counterpulsation, EECP, angina, myocardial ischemia, congestive heart failure. This search produced 1 study which met the inclusion criteria. This level 4a study was inferior in quality to the RCT which formed the basis of the 2003 Medical Advisory Secretariat recommendation. BCBS reviewed the evidence through November 2005 to determine if EECP improves health outcomes for refractory chronic stable angina pectoris or chronic stable HF. (12) BCBS concluded that the available evidence is not sufficient to permit conclusions of the effect of EECP on health outcomes. Both controlled trials had methodologic flaws (MUST EECP and MUST EECP quality of life studies). The case series and observational studies for both indications while suggestive of a treatment benefit from EECP have shortcomings as well. On March 20 2006, CMS posted their proposed coverage decision memorandum for external counterpulsation therapy. (ABSTRACT TRUNCATED)
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Ont Health Technol Assess Ser · Jan 2005
Use of automated external defibrillators in cardiac arrest: an evidence-based analysis.
The objectives were to identify the components of a program to deliver early defibrillation that optimizes the effectiveness of automated external defibrillators (AEDs) in out-of-hospital and hospital settings, to determine whether AEDs are cost-effective, and if cost-effectiveness was determined, to advise on how they should be distributed in Ontario. ⋯ The OPALS study model appears cost-effective, and effectiveness can be further enhanced by training community volunteers to improve the bystander-initiated CPR rates. Deployment of AEDs in all public access areas and in houses and apartments is not cost-effective. Further research is needed to examine the benefit of in-home use of AEDs in patients at high risk of cardiac arrest.
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Ont Health Technol Assess Ser · Jan 2005
Deep brain stimulation for Parkinson's disease and other movement disorders: an evidence-based analysis.
To determine the effectiveness and adverse effects of deep brain stimulation (DBS) in the treatment of symptoms of idiopathic Parkinson's disease, essential tremor, and primary dystonia and to do an economic analysis if evidence for effectiveness is established. ⋯ According to the estimates of prevalence and evidence of effectiveness, there is a shortfall in the numbers of DBS currently done in Ontario for drug-resistant PD, essential tremor, and primary dystonia.Since complication rates are lower if DBS is performed in specialized centres, the number of sites should be limited.The cost per procedure to institutions with the expertise to undertake DBS and the human resource considerations are likely to be limiting factors in the further diffusion of DBS.
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Ont Health Technol Assess Ser · Jan 2005
Sacral nerve stimulation for urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence: an evidence-based analysis.
The aim of this review was to assess the effectiveness, safety, and cost of sacral nerve stimulation (SNS) to treat urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence. ⋯ In summary, there is level 2 evidence to support the effectiveness of SNS to treat people with urge incontinence, urgency-frequency, or urinary retention. There is level 4 evidence to support the effectiveness of SNS to treat people with fecal incontinence. To qualify for SNS, people must meet the following criteria: Be refractory to behaviour and/or drug therapyHave had a successful test stimulation before implantation; successful test stimulation is defined by a 50% or greater improvement in voiding function based on the results of a voiding diary. Test stimulation periods range from 3 to 7 days for patients with urinary dysfunctions, and from 2 to 3 weeks for patients with fecal incontinence.Be able to record voiding diary data, so that clinical results of the implantation can be evaluated.Patients with stress incontinence, urinary retention due to obstruction and neurogenic conditions (such as diabetes with peripheral nerve involvement) are ineligible for sacral nerve stimulation. Physicians will need to learn how to use the InterStim System for Urinary Control. Requirements for training include these: Physicians must be experienced in the diagnosis and treatment of lower urinary tract disorders and should be trained in the implantation and use of the InterStim System for Urinary Control. (ABSTRACT TRUNCATED)