Therapeutic ultrasound for venous leg ulcers.

BACKGROUND: Venous leg ulcers are a type of chronic, recurring, complex wound that is more common in people aged over 65 years. Venous ulcers pose a significant burden to patients and healthcare systems. While compression therapy (such as bandages or stockings) is an effective first-line treatment, ultrasound may have a role to play in healing venous ulcers. OBJECTIVES: To determine whether venous leg ulcers treated with ultrasound heal more quickly than those not treated with ultrasound. SEARCH METHODS: We searched the Cochrane Wounds Specialised Register (searched 19 September 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library 2016, Issue 8); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations, MEDLINE Daily and Epub Ahead of Print) (1946 to 19 September 2016); Ovid Embase (1974 to 19 September 2016); and EBSCO CINAHL Plus (1937 to 19 September 2016). We also searched three clinical trials registries and the references of included studies and relevant systematic reviews. There were no restrictions based on language, date of publication or study setting. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared ultrasound with no ultrasound. Eligible non-ultrasound comparator treatments included usual care, sham ultrasound and alternative leg ulcer treatments. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the search results and selected eligible studies. Details from included studies were summarised using a data extraction sheet, and double-checked. We attempted to contact trial authors for missing data. MAIN RESULTS: Eleven trials are included in this update; 10 of these we judged to be at an unclear or high risk of bias. The trials were clinically heterogeneous with differences in duration of follow-up, and ultrasound regimens. Nine trials evaluated high frequency ultrasound; seven studies provided data for ulcers healed and two provided data on change in ulcer size only. Two trials evaluated low frequency ultrasound and both reported ulcers healed data.It is uncertain whether high frequency ultrasound affects the proportion of ulcers healed compared with no ultrasound at any of the time points evaluated: at seven to eight weeks (RR 1.21, 95% CI 0.86 to 1.71; 6 trials, 678 participants; low quality evidence - downgraded once for risk of bias and once for imprecision); at 12 weeks (RR 1.26, 95% CI 0.92 to 1.73; 3 trials, 489 participants; moderate quality evidence - downgraded once for imprecision); and at 12 months (RR 0.93, 95% CI 0.73 to 1.18; 1 trial, 337 participants; low quality evidence - downgraded once for unclear risk of bias and once for imprecision).One trial (92 participants) reported that a greater percentage reduction in ulcer area was achieved at four weeks with high-frequency ultrasound, while another (73 participants) reported no clear difference in change in ulcer size at seven weeks. We downgraded the level of this evidence to very low, mainly for risk of bias (typically lack of blinded outcome assessment and attrition) and imprecision.Data from one trial (337 participants) suggest that high frequency ultrasound may increase the risk of non-serious adverse events (RR 1.29, 95% CI 1.02 to 1.64; moderate quality evidence - downgraded once for imprecision) and serious adverse events (RR 1.21, 95% CI 0.78 to 1.89; moderate quality evidence downgraded once for imprecision).It is uncertain whether low frequency ultrasound affects venous ulcer healing at eight and 12 weeks (RR 3.91, 95% CI 0.47 to 32.85; 2 trials, 61 participants; very low quality evidence (downgraded for risk of bias and imprecision)).High-frequency ultrasound probably makes little or no difference to quality of life (moderate quality evidence, downgraded for imprecision). The outcomes of adverse effects, quality of life and cost were not reported for low-frequency ultrasound treatment. AUTHORS' CONCLUSIONS: It is uncertain whether therapeutic ultrasound (either high or low frequency) improves the healing of venous leg ulcers. We rated most of the evidence as low or very low quality due to risk of bias and imprecision.

MRI-guided focused ultrasound surgery for uterine fibroid treatment: a cost-effectiveness analysis.

OBJECTIVE. The purpose of this article is to evaluate the cost effectiveness of a treatment strategy for symptomatic uterine fibroids that uses MRI-guided focused ultrasound as a first-line therapy relative to uterine artery embolization (UAE) or hysterectomy. MATERIALS AND METHODS. We developed a decision-analytic model to compare the cost effectiveness of three first-line treatment strategies: MRI-guided focused ultrasound, UAE, and hysterectomy. Treatment-specific short- and long-term utilities, lifetime costs, and quality-adjusted life years (QALYs) were incorporated, allowing us to conduct an incremental cost-effectiveness analysis, using a societal willingness-to-pay (WTP) threshold of $50,000/QALY to designate a strategy as cost effective. Sensitivity analyses were subsequently performed on all key parameters. RESULTS. In the base-case analysis, UAE as a first-line treatment of symptomatic fibroids was the most effective and expensive strategy (22.75 QALYs; $22,968), followed by MRI-guided focused ultrasound (22.73 QALYs; $20,252) and hysterectomy (22.54 QALYs; $11,253). MRI-guided focused ultrasound was cost effective relative to hysterectomy, with an associated incremental cost-effectiveness ratio (ICER) of $47,891/QALY. The ICER of UAE relative to MRI-guided focused ultrasound was $234,565/QALY, exceeding the WTP threshold of $50,000/QALY, therefore rendering MRI-guided focused ultrasound also cost effective relative to UAE. In sensitivity analyses, results were robust to changes in most parameters but were sensitive to changes in probabilities of recurrence, symptom relief, and quality-of-life measures. CONCLUSION. First-line treatment of eligible women with MRI-guided focused ultra-sound is a cost-effective noninvasive strategy. For those not eligible for MRI-guided focused ultra-sound, UAE remains a cost-effective option. These recommendations integrate both the short- and long-term decrements in quality of life associated with the specific treatment modalities.

Managing chronic conditions: economic analysis can help mitigate costs of diabetic ulcers.

Hospital finance leaders should perform economic analyses of emerging treatments for chronic conditions that could provide cost-effective alternatives to generally accepted standards of care. One such treatment for diabetic foot ulcers (DFUs) is noncontact low-frequency ultrasound, which has been shown to reduce both costs and healing times associated with these conditions. By reviewing results of clinical trials to understand the costs and treatment considerations for DFUs and other chronic conditions, finance leaders can engage in informed conversations with physicians on how best to manage costs.

Cost analysis comparing ultrasonic fundus-first and conventional laparoscopic cholecystectomy using electrocautery.

BACKGROUND: Costs associated with laparoscopic fundus-first cholecystectomy using ultrasonic dissection versus a conventional laparoscopic cholecystectomy has not been compared. METHODS: Adult patients subjected to elective laparoscopic cholecystectomy between June 2002 and March 2004 were randomized to either an ultrasonic fundus-first dissection or dissection from the triangle of Calot with electrocautery. Differences in direct and indirect costs related to either technique were studied. RESULTS: The duration of the operation and hospitalization was longer when dissection was with the conventional technique. With the ultrasonic fundus-first technique, the direct cost was 1,190 SEK lower, and the total cost, taking also the cost for sick leave into account, was 5,370 SEK lower. CONCLUSIONS: Both direct and indirect costs are lower with a laparoscopic fundus-first cholecystectomy using ultrasonic dissection than conventional laparoscopic cholecystectomy using electrocautery.

Extracorporeal shock wave therapy (ESWT) for wound healing: technology, mechanisms, and clinical efficacy.

For almost 30 years, extracorporeal shock wave therapy has been clinically implemented as an effective treatment to disintegrate urinary stones. This technology has also emerged as an effective noninvasive treatment modality for several orthopedic and traumatic indications including problematic soft tissue wounds. Delayed/nonhealing or chronic wounds constitute a burden for each patient affected, significantly impairing quality of life. Intensive wound care is required, and this places an enormous burden on society in terms of lost productivity and healthcare costs. Therefore, cost-effective, noninvasive, and efficacious treatments are imperative to achieve both (accelerated and complete) healing of problematic wounds and reduce treatment-related costs. Several experimental and clinical studies show efficacy for extracorporeal shock wave therapy as means to accelerate tissue repair and regeneration in various wounds. However, the biomolecular mechanism by which this treatment modality exerts its therapeutic effects remains unclear. Potential mechanisms, which are discussed herein, include initial neovascularization with ensuing durable and functional angiogenesis. Furthermore, recruitment of mesenchymal stem cells, stimulated cell proliferation and differentiation, and anti-inflammatory and antimicrobial effects as well as suppression of nociception are considered important facets of the biological responses to therapeutic shock waves. This review aims to provide an overview of shock wave therapy, its history and development as well as its current place in clinical practice. Recent research advances are discussed emphasizing the role of extracorporeal shock wave therapy in soft tissue wound healing.

Economic evaluation of a randomized controlled trial of ultrasound therapy for hard-to-heal venous leg ulcers.

BACKGROUND: A pragmatic, multicentre randomized controlled trial (VenUS III) was conducted to determine whether low-dose ultrasound therapy increased the healing rate of hard-to-heal leg ulcers. This study was a cost-effectiveness analysis of the trial data. METHODS: Cost-effectiveness and cost-utility analyses were conducted alongside the VenUS III trial, in which patients were randomly allocated to either ultrasound treatment administered weekly for 12 weeks along with standard care, or standard care alone. The time horizon was 12 months and based on the UK National Health Service (NHS) perspective. RESULTS: The base-case analysis showed that ultrasound therapy added to standard care was likely to be more costly and provide no extra benefit over standard care alone. Individuals who received ultrasound treatment plus standard care took a mean of 14.7 (95 per cent confidence interval - 32.7 to 56.8) days longer to heal, had 0.009 (-0.042 to 0.024) fewer quality-adjusted life years and had higher treatment costs by £ 197.88 (-35.19 to 420.32). Based on these point estimates, ultrasound therapy plus standard care for leg ulcers was dominated by standard care alone. The analysis of uncertainty showed that this treatment strategy is unlikely to be cost-effective. CONCLUSION: Ultrasound treatment was not cost-effective for hard-to-heal leg ulcers and should not be recommended for adoption in the NHS.

Therapeutic ultrasound for venous leg ulcers.

BACKGROUND: Venous leg ulcers pose a significant burden for patients and healthcare systems. Ultrasound (US) may be a useful treatment for these ulcers. OBJECTIVES: To determine whether US increases the healing of venous leg ulcers. SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Register (searched 24 February 2010); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2010); Ovid MEDLINE (1950 to February Week 2 2010); In-Process & Other Non-Indexed Citations (searched 24 February 2010); Ovid EMBASE 1980 to 2010 Week 07; EBSCO CINAHL 1982 to 24 February 2010. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing US with no US. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the search results and selected eligible studies. Details from included studies were summarised using a data extraction sheet, and double-checked. We tried to contact trial authors for missing data. MAIN RESULTS: Eight trials were included; all had unclear, or high, risks of bias, with differences in duration of follow-up, and US regimens. Six trials evaluated high frequency US and five of these reported healing at 7 - 8 weeks. Significantly more patients healed with US than without it at 7 - 8 weeks (pooled RR 1.4, 95% CI 1.0 to 1.96), but later assessments at 12 weeks showed the increased risk of healing with US was no longer statistically significant (pooled RR 1.47, 95% CI 0.99 to 2.20). One poor-quality study of high-frequency US found no evidence of an effect on healing after three weeks' treatment.Two trials evaluated low frequency US and reported healing at different time points. Both trials reported no evidence of a difference in the proportion of ulcers healed with US compared with no US: both were significantly underpowered. AUTHORS' CONCLUSIONS: The trials evaluating US for venous leg ulcers are small, poor-quality and heterogeneous. There is no reliable evidence that US hastens healing of venous ulcers. There is a small amount of weak evidence of increased healing with US, but this requires confirmation in larger, high-quality RCTs. There is no evidence of a benefit associated with low frequency US.

Bipolar thermofusion vessel sealing system (TVS) versus conventional vessel ligation (CVL) in thyroid surgery--results of a prospective study.

INTRODUCTION: One of the keystones in surgery of the thyroid gland is accurate hemostasis. This can be achieved by conventional ligations or new instruments as harmonic scissors or bipolar devices. In the present study, we report our experience with a new bipolar thermofusion vessel sealing system (TVS) compared to conventional vessel ligation (CVL). METHODS: This prospective non-randomized study included 186 patients operated on by two surgeons between April and November 2007. Age, gender, preoperative diagnosis, type of surgery, operative time, and complications were prospectively collected. TVS was used in 93 patients (29 M, 64 F; mean age 50+/-14 years, range 11-83) and CVL in 93 patients (27 M, 66 F; mean age 49+/-14 years, range 16-82). Results and postoperative complications were registered. RESULTS: Postoperative complications included two cases of transient hypocalcaemia in both groups 1 (TVS group) and 2 (CVL group) hemorrhages requiring reoperation (p = ns). No recurrent laryngeal nerve palsy was observed in both groups. A drain was used in 25 cases in the TVS group and in 47 patients in the CVL group (p<0.008). Mean operative time for total thyroidectomy was significantly shorter in the TVS group (73+/-18 min, range=35-110) than in the CVL group (18+/-20 min, range = 40 -130; p<0.01). No differences were found for lobectomies or subtotal thyroidectomies. CONCLUSION: TVS is safe with a similar complication rate as CVL. Mean operative time for total thyroidectomy is shortened with TVS.

Sustained acoustic medicine as a non-surgical and non-opioid knee osteoarthritis treatment option: a health economic cost-effectiveness analysis for symptom management.

BACKGROUND: Patients diagnosed with osteoarthritis (OA) and presenting with symptoms are seeking conservative treatment options to reduce pain, improve function, and avoid surgery. Sustained acoustic medicine (SAM), a multi-hour treatment has demonstrated improved clinical outcomes for patients with knee OA. The purpose of this analysis was to compare the costs and effectiveness of multi-hour SAM treatment versus the standard of care (SOC) over a 6-month timeframe for OA symptom management. METHODS: A decision tree analysis was used to compare the costs and effectiveness of SAM treatment versus SOC in patients with OA. Probabilities of success for OA treatment and effectiveness were derived from the literature using systematic reviews and meta-analyses. Costs were derived from Medicare payment rates and manufacturer prices. Functional effectiveness was measured as the effect size of a therapy and treatment pathways compared to a SOC treatment pathway. A sensitivity analysis was performed to determine which cost variables had the greatest effect on deciding which option was the least costly. An incremental cost-effectiveness plot comparing SAM treatment vs. SOC was also generated using 1000 iterations of the model. Lastly, the incremental cost-effectiveness ratio (ICER) was calculated as the (cost of SAM minus cost of SOC) divided by (functional effectiveness of SAM minus functional effectiveness of SOC). RESULTS: Base case demonstrated that over 6 months, the cost and functional effectiveness of SAM was $8641 and 0.52 versus SOC at: $6281 and 0.39, respectively. Sensitivity analysis demonstrated that in order for SAM to be the less expensive option, the cost per 15-min session of PT would need to be greater than $88, or SAM would need to be priced at less than or equal to $2276. Incremental cost-effectiveness demonstrated that most of the time (84%) SAM treatment resulted in improved functional effectiveness but at a higher cost than SOC. CONCLUSION: In patients with osteoarthritis, SAM treatment demonstrated improved pain and functional gains compared to SOC but at an increased cost. Based on the SAM treatment ICER score being ≤ $50,000, it appears that SAM is a cost-effective treatment for knee OA.

From Anatomy to Functional and Molecular Biomarker Imaging and Therapy: Ultrasound Is Safe, Ultrafast, Portable, and Inexpensive.

Ultrasound is the most widely used medical imaging modality worldwide. It is abundant, extremely safe, portable, and inexpensive. In this review, we consider some of the current development trends for ultrasound imaging, which build upon its current strength and the popularity it experiences among medical imaging professional users.Ultrasound has rapidly expanded beyond traditional radiology departments and cardiology practices. Computing power and data processing capabilities of commonly available electronics put ultrasound systems in a lab coat pocket or on a user's mobile phone. Taking advantage of new contributions and discoveries in ultrasound physics, signal processing algorithms, and electronics, the performance of ultrasound systems and transducers have progressed in terms of them becoming smaller, with higher imaging performance, and having lower cost. Ultrasound operates in real time, now at ultrafast speeds; kilohertz frame rates are already achieved by many systems.Ultrasound has progressed beyond anatomical imaging and monitoring blood flow in large vessels. With clinical approval of ultrasound contrast agents (gas-filled microbubbles) that are administered in the bloodstream, tissue perfusion studies are now routine. Through the use of modern ultrasound pulse sequences, individual microbubbles, with subpicogram mass, can be detected and observed in real time, many centimeters deep in the body. Ultrasound imaging has broken the wavelength barrier; by tracking positions of microbubbles within the vasculature, superresolution imaging has been made possible. Ultrasound can now trace the smallest vessels and capillaries, and obtain blood velocity data in those vessels.Molecular ultrasound imaging has now moved closer to clinic; the use of microbubbles with a specific affinity to endothelial biomarkers allows selective accumulation and retention of ultrasound contrast in the areas of ischemic injury, inflammation, or neoangiogenesis. This will aid in noninvasive molecular imaging and may provide additional help with real-time guidance of biopsy, surgery, and ablation procedures.The ultrasound field can be tightly focused inside the body, many centimeters deep, with millimeter precision, and ablate lesions by energy deposition, with thermal or mechanical bioeffects. Some of such treatments are already in clinical use, with more indications progressing through the clinical trial stage. In conjunction with intravascular microbubbles, focused ultrasound can be used for tissue-specific drug delivery; localized triggered release of sequestered drugs from particles in the bloodstream may take time to get to clinic. A combination of intravascular microbubbles with circulating drug and low-power ultrasound allows transient opening of vascular endothelial barriers, including blood-brain barrier; this approach has reached clinical trial stage. Therefore, the drugs that normally would not be getting to the target tissue in the brain will now have an opportunity to produce therapeutic efficacy.Overall, medical ultrasound is developing at a brisk rate, even in an environment where other imaging modalities are also advancing rapidly and may be considered more lucrative. With all the current advances that we discuss, and many more to come, ultrasound may help solve many problems that modern medicine is facing.

The effects of LIPUS on soft-tissue healing: a review of literature.

INTRODUCTION: Ultrasound is widely used for imaging purposes and as an adjunct to physiotherapy. Low-intensity pulsed ultrasound (LIPUS), having removed the thermal component found at higher intensities, is used to improve bone healing. However, its potential role in soft-tissue healing is still under investigation. MATERIAL AND METHODS: We searched on Medline using the keywords: low-intensity pulsed ultrasound, LIPUS and LIPUS and soft-tissue healing. Thirty-two suitable articles were identified. RESULTS: Research, mainly pre-clinical, so far has shown encouraging result, with LIPUS able to promote healing in various soft tissues such as cartilage, inter-vertebral disc, etc. The effect on the bone-tendon junction, however, is primarily on bone. The role of LIPUS in treating tendinopathies is questionable. Adequately powered human studies with standardisation of intensities and dosages of LIPUS for each target tissue are needed.

Cost-minimisation model of magnetic resonance-guided focussed ultrasound therapy compared to unilateral deep brain stimulation for essential tremor treatment in Japan.

OBJECTIVE: To investigate the cost differences between magnetic resonance-guided focussed ultrasound (MRgFUS) and unilateral deep brain stimulation (DBS) for the treatment of medication-refractory essential tremor (ET) in Japan using a cost-minimisation model. METHODS: A cost-minimisation model estimated total costs for MRgFUS and unilateral DBS by summing the pre-procedure, procedure, and post-procedure costs over a 12-month time horizon, using data from published sources and expert clinical opinion. The model base case considered medical costs from fee-for-service tariffs. Scenario analyses investigated the use of Diagnosis Procedure Combination tariffs, a diagnosis-related group-based fixed-payment system, and the addition of healthcare professional labour costs healthcare professionals using tariffs from the Japanese Health Insurance Federation for Surgery. One-way sensitivity analyses altered costs associated with tremor recurrence after MRgFUS, the extraction rate following unilateral DBS, the length of hospitalisation for unilateral DBS and the procedure duration for MRgFUS. The impact of uncertainty in model parameters on the model results was further explored using probabilistic sensitivity analysis. RESULTS: Compared to unilateral DBS, MRgFUS was cost saving in the base case and Diagnosis Procedure Combination cost scenario, with total savings of JPY400,380 and JPY414,691, respectively. The majority of savings were accrued at the procedural stage. Including labour costs further increased the cost differences between MRgFUS and unilateral DBS. Cost savings were maintained in each sensitivity analysis and the probabilistic sensitivity analysis, demonstrating that the model results are highly robust. CONCLUSIONS: In the Japanese healthcare setting, MRgFUS could be a cost saving option versus unilateral DBS for treating medication-refractory ET. The model results may even be conservative, as the cost of multiple follow-ups for unilateral DBS and treatment costs for adverse events associated with each procedure were not included. This model is also consistent with the results of other economic analyses of MRgFUS versus DBS in various settings worldwide.

Cost-effectiveness of magnetic resonance-guided focused ultrasound surgery for treatment of uterine fibroids.

OBJECTIVE: To estimate the cost-effectiveness of a treatment strategy for symptomatic uterine fibroids, which starts with Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) as compared with current practice comprising uterine artery embolisation, myomectomy and hysterectomy. DESIGN: Cost-utility analysis based on a Markov model. SETTING: National Health Service (NHS) Trusts in England and Wales. POPULATION: Women for whom surgical treatment for uterine fibroids is being considered. METHODS: The parameters of the Markov model of the treatment of uterine fibroids are drawn from a series of clinical studies of MRgFUS, and from the clinical effectiveness literature. Health-related quality of life is measured using the 6D. Costs are estimated from the perspective of the NHS. The impact of uncertainty is examined using deterministic and probabilistic sensitivity analysis. MAIN OUTCOME MEASURES: Incremental cost-effectiveness measured by cost per quality-adjusted life-year (QALY) gained. RESULTS: The base-case results imply a cost saving and a small QALY gain per woman as a result of an MRgFUS treatment strategy. The cost per QALY gained is sensitive to cost of MRgFUS relative to other treatments, the age of the woman and the nonperfused volume relative to the total fibroids volume. CONCLUSIONS: A treatment strategy for symptomatic uterine fibroids starting with MRgFUS is likely to be cost-effective.

Therapeutic ultrasound for venous leg ulcers.

BACKGROUND: Venous leg ulceration is a common problem, representing a significant burden on the patient and the healthcare system. They are caused by venous insufficiency and tend to be chronic and recurring. Management usually includes use of wound dressings plus compression stockings or bandages. It has been suggested that therapeutic ultrasound may have an adjuvant effect and promote healing however its effects are unclear. OBJECTIVES: To determine whether therapeutic ultrasound increases the healing of venous leg ulcers. SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Register (August 2007), The Cochrane Central Register of Controlled Trials (CENTRAL) - The Cochrane Library Issue 3, 2007, Ovid MEDLINE - 1950 to July Week 4 2007, Ovid EMBASE - 1980 to 2007 Week 31, Ovid CINAHL - 1982 to August Week 1 2007. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing therapeutic ultrasound with placebo (sham) ultrasound, or other (standard) treatment. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the results of the searches for eligible RCTs and obtained full reports. A third author assessed the results of the update searches for eligible RCTs. Details from the eligible studies were extracted and summarised by a review author using a data extraction sheet. Attempts were made to contact trial authors to obtain missing data or for clarification. MAIN RESULTS: A total of eight eligible trials were identified and were all of either medium or high risk of bias. Five trials compared ultrasound therapy with placebo (sham) ultrasound, three trials compared ultrasound therapy with standard treatment. Trials varied in terms of ulcer size, regimen and duration of follow up. No trials individually found a statistically significant difference in the number of ulcers healed between any of the therapies, however on pooling trials (different durations of follow up) for the outcome of risk healing, significantly more ulcers were completely healed with ultrasound (RR 1.49, 95% CI 1.07 to 2.09). Some trials also found that ultrasound increases the rate of change of wound size and/or reduces the size of existing ulcers, whilst other trials did not find this effect to be significant. When all trials reporting percentage ulcer area remaining were pooled there was a significant benefit associated with ultrasound (WMD -5.34%, 95% CI -8.38 to -2.30). AUTHORS' CONCLUSIONS: The available evidence suggests that ultrasound may increase healing of venous leg ulcers. These conclusions are based on the results of only eight small studies of generally poor quality and therefore should be interpreted with caution.

Use of the harmonic scalpel versus conventional haemostatic techniques in patients with Grave disease undergoing total thyroidectomy: a prospective randomised controlled trial.

INTRODUCTION: Thyrotoxicosis is often considered to be the most difficult thyroid operation because of the high vascularisation and the risk of bleeding. The conventional haemostatic technique in thyroidectomy today include knot tying and electrocoagulation. The introduction of the harmonic scalpel (HS) has led to further research if the use of the HS has any benefits in thyroid surgery. To our knowledge, no previous study has evaluated the HS dissection technique in a homogenous group of patients with Graves' disease undergoing total thyroidectomy. MATERIALS AND METHODS: Fifty-one patients (39 women and 12 men) with the pre-operative diagnosis of Graves' disease treated at two endocrine centers were randomised to total thyroidectomy with the use of the HS or with conventional haemostatic techniques. RESULTS: Twenty-seven patients were randomised to the harmonic group and 24 to the conventional group. The operating time was shorter in the HS group (median, 121 min; range, 84-213 min) compared to the conventional group (median, 172 min; range, 66-268 min; p = 0.011). CONCLUSION: The use of the HS was associated with a significant reduction in operating time compared to the use of the conventional haemostatic techniques in patients with Graves' disease undergoing total thyroidectomy.

The use of "harmonic scalpel" versus "knot tying" for conventional "open" thyroidectomy: results of a prospective randomized study.

PURPOSE: We evaluated the safety and cost-effectiveness of the harmonic scalpel (HS) during conventional "open" thyroidectomy (CT). MATERIALS AND METHODS: Two hundred patients scheduled for conventional total thyroidectomy (TT) were included in the study and randomly assigned to TT with the use of HS (HS group) or with knot tying technique (KT group). RESULTS: Mean operative time was significantly shorter in the HS group (P < 0.001), as well as the total operative room occupation time (P < 0.001). The cost of the disposable materials is significantly higher in the HS group (420.1 +/- 23.2 vs 137.8 +/- 25.3 euros; P < 0.001). Conversely, drugs, personnel and operative room charges were significantly higher in KT group patients (P < 0.001). Overall, no significant difference was found between the two groups concerning the charges of the hospitalisation (P = NS). CONCLUSIONS: HS is a safe alternative to KT, allowing for a significant reduction of operative time without increasing complications rate and overall costs and probably better utilization of health resources.

[Ultrasonic scissors. New vs resterilized instruments]. / Ultraschallscheren. Neue vs. resterilisierte Einmalinstrumente.

BACKGROUND: The aim of this study was to compare reliability in handling and function of resterilized and single-use disposable ultrasonic scissors. METHODS: In a prospective randomized study, the surgeon blindly tested new and resterilized ultrasonographic scissors. The parameters were force of activation, cutting effect, coagulation effect, error messages, and disturbing generator noise. RESULTS: Fifty-one new and 49 resterilized instruments in 94 operations were evaluated. The differences in force of activation, cutting effect, and coagulation were not significant. Error messages and disturbing noises were rare in both groups. Six new instruments and two resterilized instruments had to be exchanged because of problems during surgery. CONCLUSION: This study demonstrates comparable reliability in function and handling of resterilized and new ultrasonic scissors. The use of resterilized instruments leads to distinctly reduced costs and could contribute to efficiency in laparoscopic surgery.

Magnetic Resonance-Guided Focused Ultrasound Neurosurgery for Essential Tremor: A Health Technology Assessment.

BACKGROUND: The standard treatment option for medication-refractory essential tremor is invasive neurosurgery. A new, noninvasive alternative is magnetic resonance-guided focused ultrasound (MRgFUS) neurosurgery. We aimed to determine the effectiveness, safety, and cost-effectiveness of MRgFUS neurosurgery for the treatment of moderate to severe, medication-refractory essential tremor in Ontario. We also spoke with people with essential tremor to gain an understanding of their experiences and thoughts regarding treatment options, including MRgFUS neurosurgery. METHODS: We performed a systematic review of the clinical literature published up to April 11, 2017, that examined MRgFUS neurosurgery alone or compared with other interventions for the treatment of moderate to severe, medication-refractory essential tremor. We assessed the risk of bias of each study and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic review of the economic literature and created Markov cohort models to assess the cost-effectiveness of MRgFUS neurosurgery compared with other treatment options, including no surgery. We also estimated the budget impact of publicly funding MRgFUS neurosurgery in Ontario for the next 5 years. To contextualize the potential value of MRgFUS neurosurgery as a treatment option for essential tremor, we spoke with people with essential tremor and their families. RESULTS: Nine studies met our inclusion criteria for the clinical evidence review. In noncomparative studies, MRgFUS neurosurgery was found to significantly improve tremor severity and quality of life and to significantly reduce functional disability (GRADE: very low). It was also found to be significantly more effective than a sham procedure (GRADE: high). We found no significant difference in improvements in tremor severity, functional disability, or quality of life between MRgFUS neurosurgery and deep brain stimulation (GRADE: very low). We found no significant difference in improvement in tremor severity compared with radiofrequency thalamotomy (GRADE: low). MRgFUS neurosurgery has a favourable safety profile.We estimated that MRgFUS neurosurgery has a mean cost of $23,507 and a mean quality-adjusted survival of 3.69 quality-adjusted life-years (QALYs). We also estimated that the mean costs and QALYs of radiofrequency thalamotomy and deep brain stimulation are $14,978 and 3.61 QALYs, and $57,535 and 3.94 QALYs, respectively. For people ineligible for invasive neurosurgery, we estimated the incremental cost-effectiveness ratio (ICER) of MRgFUS neurosurgery compared with no surgery as $43,075 per QALY gained. In people eligible for invasive neurosurgery, the ICER of MRgFUS neurosurgery compared with radiofrequency thalamotomy is $109,795 per QALY gained; when deep brain stimulation is compared with MRgFUS neurosurgery, the ICER is $134,259 per QALY gained. Of note however, radiofrequency thalamotomy is performed very infrequently in Ontario. We also estimated that the budget impact of publicly funding MRgFUS neurosurgery in Ontario at the current case load (i.e., 48 cases/year) would be about $1 million per year for the next 5 years.People with essential tremor who had undergone MRgFUS neurosurgery reported positive experiences with the procedure. The tremor reduction they experienced improved their ability to perform activities of daily living and improved their quality of life. CONCLUSIONS: MRgFUS neurosurgery is an effective and generally safe treatment option for moderate to severe, medication-refractory essential tremor. It provides a treatment option for people ineligible for invasive neurosurgery and offers a noninvasive option for all people considering neurosurgery.For people ineligible for invasive neurosurgery, MRgFUS neurosurgery is cost-effective compared with no surgery. In people eligible for invasive neurosurgery, MRgFUS neurosurgery may be one of several reasonable options. Publicly funding MRgFUS neurosurgery for the treatment of moderate to severe, medication-refractory essential tremor in Ontario at the current case load would have a net budget impact of about $1 million per year for the next 5 years.People with essential tremor who had undergone MRgFUS neurosurgery reported positive experiences. They liked that it was a noninvasive procedure and reported a substantial reduction in tremor that resulted in an improvement in their quality of life.

A health economic evaluation of concomitant surgical ablation for atrial fibrillation.

OBJECTIVE: Current drug treatment for atrial fibrillation is suboptimal and percutaneous catheter-based ablation techniques may be associated with complications. The aim of this study is to assess the cost-effectiveness of (1) high-intensity focused ultrasound (HIFU)-assisted surgical ablation, (2) the classic 'cut and sew' maze procedure and (3) percutaneous ablation, all concomitant to cardiac surgery (e.g. CABG, valve repair) in comparison with non-interventional (drug) treatment. METHODS: A Markov model was developed to predict the cost-effectiveness of the interventional approaches. The model consisted of four disease states (sinus rhythm without complications, atrial fibrillation without complications, stroke and death), allowing for 3-monthly transitions between these states and using direct UK costs from the National Health Service perspective. Clinical input data are obtained from literature and cost input data from National Health Service sources and literature. Five-year total and incremental costs are calculated. Incremental effects are expressed in quality-adjusted-life-years-gained (QALYG). RESULTS: All interventional treatments show good incremental cost-effectiveness ratios in all atrial fibrillation types, compared to drug treatment. For classic maze the incremental cost-effectiveness ratio compared to non-interventional atrial fibrillation treatment varies from 1343 to 3471 GBP/QALYG, for HIFU-assisted surgical ablation from 4005 to 7448 GBP/QALYG and for percutaneous ablation from 7041 to 17,372 GBP/QALYG depending on the atrial fibrillation type. Sensitivity analyses showed the robustness of the data. CONCLUSIONS: Performing a classic maze procedure or HIFU-assisted surgical ablation concomitant to a scheduled CABG or valve procedure is highly cost-effective. Performing a percutaneous ablation in a subsequent procedure is also cost-effective, but to a lower extent. Both the maze procedure and the HIFU-assisted surgical ablation are cheaper and more effective than percutaneous ablation in a subsequent procedure.

Low-intensity pulsed ultrasound for treatment of tibial fractures: an economic evaluation of the TRUST study.

AIMS: This 501-patient, multi-centre, randomised controlled trial sought to establish the effect of low-intensity, pulsed, ultrasound (LIPUS) on tibial shaft fractures managed with intramedullary nailing. We conducted an economic evaluation as part of this trial. PATIENTS AND METHODS: Data for patients' use of post-operative healthcare resources and time taken to return to work were collected and costed using publicly available sources. Health-related quality of life, assessed using the Health Utilities Index Mark-3 (HUI-3), was used to derive quality-adjusted life years (QALYs). Costs and QALYs were compared between LIPUS and control (a placebo device) from a payer and societal perspective using non-parametric bootstrapping. All costs are reported in 2015 Canadian dollars unless otherwise stated. RESULTS: With a cost per device of $3,995, the mean cost was significantly higher for patients treated with LIPUS versus placebo from a payer (mean increase = $3647, 95% confidence interval (CI) $3244 to $4070; p < 0.001) or a societal perspective (mean increase = $3425, 95% CI $1568 to $5283; p < 0.001). LIPUS did not provide a significant benefit in terms of QALYs gained (mean difference = 0.023 QALYs, 95% CI -0.035 to 0.069; p = 0.474). Incremental cost-effectiveness ratios of LIPUS compared with placebo were $155 433/QALY from a payer perspective and $146 006/QALY from a societal perspective. CONCLUSION: At the current price, LIPUS is not cost-effective for fresh tibial fractures managed with intramedullary nailing. Cite this article: Bone Joint J 2017;99-B:1526-32.