Ontario health technology assessment series
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Ont Health Technol Assess Ser · Jan 2006
Gastric electrical stimulation: an evidence-based analysis.
The objective of this analysis was to assess the effectiveness, safety and cost-effectiveness of gastric electrical stimulation (GES) for the treatment of chronic, symptomatic refractory gastroparesis and morbid obesity. ⋯ "For use in weight reduction for obese adults with a body mass index greater than 35."The GES device that is licensed by Health Canada for treatment of GP, produces high-frequency GES. Most clinical studies examining GES for GP have used high-frequency (4 times the intrinsic slow wave frequency, i.e., 12 cycles per minute), low energy, short duration pulses. This type of stimulation does not alter gastric muscular contraction and has no effect on slow wave dysrhythmias. The mechanism of action is unclear but it is hypothesized that high-frequency GES may act on sensory fibers directed to the CNS. The GES device licensed by Health Canada for treatment of morbid obesity produces low-frequency GES, which is close to or just above the normal/native gastric slow wave cycle (approximately 3 cycles/min.). This pacing uses low-frequency, high-energy, long-duration pulses to induce propagated slow waves that replace the spontaneous ones. Low-frequency pacing does not invoke muscular contractions. Most studies examining the use of GES for the treatment of morbid obesity use low-frequency GES. Under normal circumstances, the gastric slow wave propagates distally and determines the frequency and propagation direction of gastric peristalsis. Low-frequency GES aims to produce abnormal gastric slow waves that can induce gastric dysrhythmia, disrupt regular propagation of slow waves, cause hypomotility of the stomach, delay gastric emptying, reduce food intake, prolong satiety, and produce weight loss. In the United States, the Enterra Therapy System is a Humanitarian Use Device (HUD), meaning it is a medical device designated by the FDA for use in the treatment of medical conditions that affect fewer than 4,000 individuals per year. The Enterra Therapy System is indicated for "the treatment of chronic, drug- refractory nausea and vomiting secondary to GP of diabetes or idiopathic etiology" (not postsurgical etiologies). GES for morbid obesity has not been approved by the FDA and is for investigational use only in the United States. (ABSTRACT TRUNCATED)
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To assess the effectiveness, safety and cost-effectiveness of extracorporeal photophoresis (ECP) for the treatment of refractory erythrodermic cutaneous T cell lymphoma (CTCL) and refractory chronic graft versus host disease (cGvHD). ⋯ The UVAR XTS Photopheresis System is licensed by Health Canada as a Class 3 medical device (license # 7703) for the "palliative treatment of skin manifestations of CTCL." It is not licensed for the treatment of cGvHD. UVADEX (sterile solution methoxsalen) is not licensed by Health Canada, but can be used in Canada via the Special Access Program. (Personal communication, Therakos, February 16, 2006) According to the manufacturer, the UVAR XTS photopheresis system licensed by Health Canada can also be used with oral methoxsalen. (Personal communication, Therakos, February 16, 2006) However, oral methoxsalen is associated with side effects, must be taken by the patient in advance of ECP, and has variable absorption in the gastrointestinal tract. (ABSTRACT TRUNCATED)
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Ont Health Technol Assess Ser · Jan 2006
Ablation for atrial fibrillation: an evidence-based analysis.
To review the effectiveness, safety, and costing of ablation methods to manage atrial fibrillation (AF). The ablation methods reviewed were catheter ablation and surgical ablation. ⋯ Catheter ablation appears to be an effective treatment for patients with drug-refractory AF whose treatment alternatives are limited. Ablation technology is continually evolving with increasing success rates associated with the ablation procedure.
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Ont Health Technol Assess Ser · Jan 2006
Routine eye examinations for persons 20-64 years of age: an evidence-based analysis.
The objective of this analysis was to determine the strength of association between age, gender, ethnicity, family history of disease and refractive error and the risk of developing glaucoma or ARM? ⋯ The total cost of a major eye examination by a physician is $42. (ABSTRACT TRUNCATED)
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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)