Emerging Technology Bulletin · implant for male stress urinary incontinence. Based on the lack of information from randomised, controlled trials and the potential to be an alternative

The horizon scanning network Welcome to the first edition of the Horizon Scanning Network Newsletter. The Australia and New Zealand Horizon Scanning Network(ANZHSN) is an initiative of the Medical Services Advisory Committee (MSAC), the Australian Government Department of Health and Ageing (DoHA) and all Australian Health Ministers' Advisory Council (AHMAC) jurisdiction. The horizon scanning program was established under MSAC to provide advance notice of significant new and emerging technologies to health departments in Australia and New Zealand, and to exchange information and evaluate the potential impact of emerging technologies on their respective health systems. Central to the operation of the ANZHSN is the Health Policy Advisory Committee on Technology (HealthPACT). HealthPACT is a

Issue 1, January 2007

Emerging Technology Bulletin ‘New health technologies identified through the Australia and New Zealand Horizon Scanning Network (ANZHSN)’

ANZHSN News - www.horizonscanning.gov.au

In This Issue... Magnetic resonance spectroscopy for the diagnosis of suspected breast malignancies ........................................2 ProACTTM therapy for male stress urinary incontinence .........................................3 Cryoplasty utilising the PolarCathTM peripheral dilation system ....................4 TandemHeart® percutaneous ventricular assist device ........................................5 Intralase femtosecond laser .................6 Dose verification system® for the measurement of the radiation dosage received at the tumour site in patients with breast or prostate cancer..............7 Renessa® radiofrequency micro-remodelling treatment for female stress urinary incontinence ..................8

sub-committee of MSAC and comprises representatives from State and Territory government health departments, the Medical Services Advisory Committee, DoHA and the New Zealand Ministry of Health and District Health Boards. HealthPACT's work is supported by the National Horizon Scanning Unit (NHSU), funded to undertake horizon scanning and produce Horizon scanning prioritising summaries and Horizon scanning reports as well as a register of new and emerging health technologies including devices, diagnostic tests and procedures, and other non-surgical interventions. A close collaborator is NET-S which was established by the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S) to provide an early warning system for identifying emerging surgical techniques and technologies. ASERNIP-S is a programme of the Royal Australasian College of Surgeons which assesses new surgical procedures, and is primarily funded by the Australian DoHA. NET-S provides Horizon scanning prioritising summaries and Horizon scanning reports on new and emerging surgical technologies and techniques. In future editions of the newsletter I plan to cover in detail some of the important HealthPACT activities and products mentioned above.

Best Regards, Brendon Kearney

Chair of HealthPACT

Magnetic resonance spectroscopy (MRS) for the diagnosis of suspected breast malignancies

Emerging Technology Bulletin

Mammography is a cost-effective, accurate and well accepted imaging modality for the diagnosis of breast cancer, but has decreased efficiency in women with dense breast tissue, or for those who have had breast surgery or silicone augmentation1. For these women, magnetic resonance imaging (MRI) may offer a more reliable method for diagnosing breast cancer. Magnetic resonance spectroscopy (MRS) is an application of MRI that provides biochemical information about tissue metabolism.

HOW IT WORKS MRS can be performed on MRI equipment using specialised software packages. Unlike MRI, which detects the resonance spectra of water in tissues, MRS detects the resonance spectra of a variety of chemical compounds, thereby allowing for a description of in situ chemistry4. Proton 1H MRS is increasingly being studied as a potential adjunct to MRI in the classification of suspicious lesions of the breast. The diagnostic value of proton 1H MRS is based on the detection of choline-containing compounds, which are markers of cancerous tissue5. Studies have found that malignant lesions (and not benign lesions) contain choline-containing compounds, particularly phosphocholine, that resonate at a chemical shift of 3.2ppm6. For benign lesions where MRI is inconclusive, MRS may eliminate the need for biopsy by demonstrating the lack of a choline resonance at a chemical shift of 3.2ppm. The incorporation of MRS into a breast MRI examination takes less than 10 minutes7.

THE EVIDENCE Using biopsy results as the gold standard, 38 women who presented with a suspicious mass in the breast of 1cm in diameter or larger, underwent MRS with sensitivity and specificity reported to be 83 and 87 per cent respectively. The authors noted that if tubular adenomas, a well-known source of false positive readings on MRS, had been excluded by the

MRI, the specificity and positive predictive value of MRS would have improved to 93 and 95 per cent respectively7. The diagnostic performance of MRS and MRI in 56 patients with 57 distinct lesions was investigated. Using biopsy as a gold standard, 31 and 26 of the 57 lesions were found to be malignant and benign respectively. A choline peak was found in all 31 biopsy-proven malignant lesions (100% sensitivity), while peaks were absent in 23 of 26 benign lesions (88% specificity)8.

FUTURE STEPS Although it is unclear how easily MRS could be incorporated into an MRI examination of the breast in Australia, the technology may offer benefits to a select group of patients. At present an MSAC report into the use of MRI for diagnosing breast cancer in high risk women is pending completion. It is recommended that MRS for breast cancer examination be monitored until the results of the MSAC assessment are finalised.

Written by Tom Sullivan, AHTA

REFERENCES 1. Friedrich, M. (1998). 'MRI of the breast: state of the art', Eur Radiol, 8 (5), 707-725. 2. AIHW (2006). BreastScreen Australia monitoring report 2002-2003, Australian Institute of Health and Welfare, Canberra. 3. NHMRC (1999). Familial aspects of cancer: a guide to clinical practice, National Health and Medical Research Council (NHMRC), Canberra. 4. Shah, N., Sattar, A. et al (2006). 'Magnetic resonance spectroscopy as an imaging tool for cancer: a review of the literature', J Am Osteopath Assoc, 106 (1), 23-27. 5. Negendank, W. (1992). 'Studies of human tumors by MRS: a review', NMR Biomed, 5 (5), 303-324. 6. Roebuck, J. R., Cecil, K. M. et al (1998). 'Human breast lesions: characterization with proton MR spectroscopy', Radiology, 209 (1), 269-275. 7. Cecil, K. M., Schnall, M. D. et al (2001). 'The evaluation of human breast lesions with magnetic resonance imaging and proton magnetic resonance spectroscopy', Breast Cancer

Res Treat, 68 (1), 45-54. 8. Bartella, L., Morris, E. A. et al (2006). 'Proton MR spectroscopy with choline peak as malignancy marker improves positive predictive value for breast cancer diagnosis:

preliminary study', Radiology, 239 (3), 686-692.

2. Issue 1 January 2007

Above: An MRI machine. “MRS can be performed on MRI equipment using specialised software packages”


ProACTTM Therapy for male stress urinary incontinence Urinary incontinence is the inability to hold urine in the bladder and prevent involuntary leaking or dribbling. Urinary incontinence in men can sometimes result from conditions of the prostate (an exocrine gland that surrounds the urethra just below the bladder) and their treatment1.

HOW IT WORKS The ProACT Therapy system consists of a set of two post-operatively adjustable balloons attached to a titanium port via a short length of tubing. They are inserted via a perin-eal approach bilaterally in a peri-urethral position at the bladder neck or at the apex of the prostatic remnant. The tita-nium ports, which are sited in the scrotum allow for future percutaneous volume adjustments of the balloons using a fine gauge needle. The implant is designed to increase coaption of the urethra and lift the bladder neck, helping to improve continence. The required implantation procedure is minimally invasive and is able to be performed with general or spinal anaesthesia5.

THE EVIDENCE The ProACT Therapy system was assessed in 117 consecutive men (110 post-RP, six post-TURP, one after radical cystectomy and neobladder). The median period of incontinence was 33 months and 87% of men had been incontinent for over a year prior to implantation of the device. The implantation procedure was uneventful in 96 men, however, 15 suffered urethral or bladder perforations and the outcome of 6 men was not reported. Only5 men experienced full continence and required no adjustment of balloon volume on the first day after surgery. The remaining 112 (96%) required a median of three volume adjustments to achieve satisfactory results. Twenty-one patients experienced 24 balloon ruptures, all of which were successfully replaced 1-2 months later. No further complications from the rupture of the balloons were reported. Seventeen implant migrations (16 unilateral, 1 bilateral) were also reported in 16 patients but were successfully repositioned. Erosion of the urethra and bladder was also reported in 13 patients (11 unilateral, 2 bilateral). In these patients removal of the implants was

required followed by re-implantation six weeks later. Additionally, 31 more explantations due to non-response were performed without any complications. Scores in the IQoL quality of life questionnaire (maximum score 100) improved from a baseline mean of 34.7 in 117 men to 64.8 at six months in 92 men, 64.9 at 12 months in 63 men and 66.3 at 24 months in 42 men.

Several other studies reported similar results.

FINAL STEPS Higher quality studies, preferably randomised controlled trials are required to better evaluate the safety and efficacy of this implant for male stress urinary incontinence. Based on the lack of information from randomised, controlled trials and the potential to be an alternative form of treatment for male post-prostatectomy stress urinary incontinence, HealthPACT recommended that this technology be monitored:

Written by Luis Zamora, ASERNIP-S

January 2007 Issue 1 3.

REFERENCES 1. University of Pittsburgh Medical Center, Cancer Centers. Prostate cancer.

Last updated August 2006. http://www.upmccancercenters.com/cancer/prostate/incontinence.html [Accessed August 2006].

2. Rassweiler J, Teber D, Kuntz R, Hofmann R. Complications of Transurethral Resection of the Prostate (TURP) – Incidence, management and prevention. European Urology 2006; [Epub ahead of print].

3. Stanford JL, Feng Z, Hamilton AS, Gilliland FD, Stephenson RA, Eley JW, Albertsen PC, Harlan LC, Potosky AL. Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer – The prostate cancer outcomes study. JAMA 2000;283(3):354-360.

4. Peyromaure M, Ravery V, Boccon-Gibod L. The management of stress urinary incontinence after radical prostatectomy. BJU International 2002;90(2):155-161.

5. Uromedica Inc. ProACT Therapy for post-prostatectomy stress incontinence. Last updated March 2006. http://uromedica-inc.com/ous/proact-physicians [Accessed July 2006].

6. Trigo-Rocha F, Gomes CM, Pompeo AC, Lucon AM, Arap S. Prospective study evaluating efficacy and safety of adjustable continence therapy (ProACT) for post radical prostatectomy urinary incontinence. Urology 2006;67(5):965-969.

7. Hubner WA, Schlarp OM. Treatment of incontinence after prostatectomy

using a new minimally invasive device: adjustable continence therapy. BJU International 2005;96(4):587-594.

Below: Cross-section of an implantable balloon. (Printed Permission from Uromedica, Inc)

Cryoplasty utilising the PolarCathTM peripheral dilation system

ASNZHSN News

Revascularisation with angioplasty is the current gold standard minimally invasive treatment for peripheral arterial disease. If cryoplasty is proven to be safe and substantially more effective compared to conventional angioplasty, it is likely to be adopted rapidly into the Australian healthcare system.

HOW IT WORKS On the surface, cryotherapy appears to be very similar to conventional angioplasty. However, the key difference is that cryotherapy is performed using nitrous oxide as a dilation medium for the balloon as opposed to a saline and contrast mixture. The nitrous oxide utilized in this technique is not released into the arterial compartment; instead it is harnessed to cool the interface between the delivery balloon and the vessel wall to -10 °C. This abrupt drop in temperature induces apoptosis in the cells that are typically believed to contribute to the process of restenosis. Cell death or apoptosis is triggered by the freezing process which forms intracellular ice, forcing water out of the cell and causing the internal environment to become substantially hypertonic. In addition to this, the compliance differences between the plaque and vessel wall are mitigated due to the freezing process, therefore allowing the lesion to release in a more benign fashion and with lower risks of deep vessel wall tears2. The system designed specifically for cryotherapy is the PolarCath peripheral dilatation system. The PolarCath balloon is outwardly similar to a conventional balloon, but in actual fact is comprised of two balloons in parallel. The space between the two balloons houses a textile fabric which acts as an insulator to deliver the desired temperature more accurately. The dual balloon configuration also acts as a safety feature, a vacuum is created between the balloons due to expansion; any loss of vacuum would therefore be interpreted as balloon rupture, resulting in immediate automatic shutdown of the system. The inflation procedure is automated and regulated by a cryoinflation unit, a microprocessor controlled device that integrates the PolarCath balloon and the nitrous oxide cylinder (a disposable 14g cartridge)2.

THE EVIDENCE The overall success rates in patients (including those with underlying risk factors such as diabetes and occlusion of target vessel) appears to be satisfactory, with mid-term clinical patency rates of 82-92%3,4. Long-term clinical patency was available from one study5, which reported a 75% patency rate 3.5 years post-cryotherapy. Despite encouraging results from several studies, cryoplasty appears to be completely ineffective in preventing restenosis in a select patient cohort which had



Below: An inflation unit, a catheter, and a nitrous oxide cartridge (Printed permission from Boston Scientific)

recurrent neointimal hyperplasia (a condition whereby cryoplasty was meant to be capable of resolving)6.

FUTURE STEPS Current evidence for the safety and efficacy of cryotherapy is lacking. The absence of comparative studies severely limits the arguments that cryoplasty is substantially more effective compared to conventional angioplasty with stenting. Furthermore, comparisons with historical results, although promising, is to a large extent limited due to the difference of lesions treated, poor follow-up protocols, patients of different clinical stages of peripheral vascular disease and the use of simple clinical follow-up examinations instead of medical imaging techniques. Based on the evidence available, HealthPACT recommended that this technology be monitored.

Written by Irving Lee, ASERNIP-S

REFERENCES

1. AIHW. Peripheral vascular disease. Last updated 2006. htp://www.aihw.gov.au/cvd/majordiseases/peripheral.cfm [Accessed August 2006].

2. Joye JD. The clinical application of cryoplasty for infrainguinal peripheral

arterial disease. Techniques in Vascular and Interventional Radiology 2005; 8(4): 160-164.

3. Fava M, Loyola S, Polydorou A, Papapavlou P, Polydorou A, Mendiz O, Joye JD. Cryoplasty for femoropopliteal arterial disease: Late angiographic results of initial human experience. Journal of Vascular and Interventional Radiology 2004; 15(11): 1239-1243.

4. Laird J, Jaff MR, Biamino G, McNamara T, Scheinert D, Zetterlund P, Moen E, Joye JD. Cryoplasty for the treatment of femoropopliteal arterial disease: Results of a prospective, multicentre registry. Journal of Vascular and Inter-ventional Radiology 2005; 16(8): 1067-1073.

5. Laird JR, Biamino G, McNamara T, Scheinert D, Zetterlund P, Moen E, Joye JD. Cryoplasty for the treatment of femoropopliteal arterial disease: Extended follow-up results. Journal of Endovascular Therapy 2006; 13(S2): II52-59.

6. Karthik S, Tuite DJ, Nicholson AA, Patel JV, Shaw DR, McPherson SJ, Kessel DO. Cryoplasty for arterial restenosis. European Journal of Endovascular Surgery 2006 [Article in press].

TandemHeart® percutaneous ventricular assist device Cardiogenic shock is characterised by inadequate circulation of blood due to decreased pumping ability of the heart that results in global hypoperfusion. Cardiogenic shock occurs in 7-10% of those with acute myocardial infarction (AMI)1 and is the leading cause of death in these patients. For those who have received rapid revascularisation, the mortality rate is 30-50% and approximately 70% if revascularisation is not performed2.

HOW IT WORKS TandemHeart®, was developed to address the shortcomings of intra-aortic balloon pumping (IABP) and extracorporeal membrane oxygenation. The Tandemheart percutaneous ventricular assist device is a low-speed centrifugal continuous-flow pump with a low blood surface contact area (to reduce the risk for hemolysis and thromboemboli), which is placed outside the body. This device requires the percutaneous insertion of cannulas through the femoral vein and advanced across the intraatrial septum into the left atrium. The TandemHeart pump withdraws oxygenated blood from the left atrium and propels it utilising a magnetically-driven, six-bladed impeller through the outflow port and returns the blood to one or both femoral arteries via arterial cannulas. The pump also has a proprietary fluid-infusion system that provides cooling and lubrication to the impeller and enhances thromboresistance. The system provides localized anticoagulation to the blood inside the pump, reducing the need for systemic anticoagulation4. In patients with cardiogenic shock it can be used for short-term circulatory support to obtain stabilization or as a bridge to definitive surgical treatment.

THE EVIDENCE Current research indicates that the Tandemheart pVAD is capable of reversing cardiogenic shock and has the potential to outperform IABP. However, despite the evidence that the TandemHeart pVAD appears to improve haemodynamic

parameters, the value of these improvements have to be considered in the light of the higher complication rates as well as the 30-day mortality rate (~44% to 53%)1,5,6,7 which is comparable to that of IABP (30% to 50%). It is important to note that despite the expectation that the pVAD would overcome the limitations of IABP in cardiogenic shock patients with severely depressed left ventricular function7 none of the patient groups in the included studies had substantial depression of left ventricular function. Perhaps the use of the device in these patients would better highlight its value, however this remains to be proven and further research is warranted in view of these points.

FUTURE STEPS In view of the available evidence, HealthPACT recommended that this technology be monitored.



REFERENCES 1. Thiele H, Lauer B, Hambrecht R, Boudriot E, Cohen HA, Schuler G. Reversal of cardiogenic shock by percutaneous left atrial-to-femoral arterial bypass assistance. Circulation

2001; 104(24): 2917-2922. 2. Brandler ES and Sinert R. Cardiogenic Shock. Last updated 2006. http://www.emedicine.com/emerg/topic530.htm [Accessed July 2006]. 3. Australian Institute of Health and Welfare: Admissions and in-hospital treatment of myocardial infarction. Last updated 2005. http://www.aihw.gov.au/publications/cvd/echdta/echdta-

c05.pdf [Accessed July 2006]. 4. Cardiac Assist Inc. Last updated 2006. http://www.cardiacassist.com/TandemHeart/ [Accessed July 2006]. 5. Burkhoff D, Cohen H, Brunckhorst C, O’Neill WW. A randomized multicenter clinical study to evaluate the safety and efficacy of the TandemHeart percutaneous ventricular

assist device versus conventional therapy with intraaortic balloon pumping for treatment of cardiogenic shock. American Heart Journal 2006a; 152(3): 469e1-e8. 6. Burkhoff D, O’Neill W, Brunckhorst, Letts D, Lasorda D, Cohen HA. Feasibility study of the use of the TandemHeart® percutaneous ventricular assist device for treatment of

cardiogenic shock. Catheterization and Cardiovascular Intervention 2006b; 68(2): 211-217. 7. Thiele H, Sick P, Boudriot E, Diederich K, Hambrecht R, Niebauer J, Schuler G. Randomised comparison of intra-aortic balloon support with a percutaneous left ventricular assist

device in patients with revascularized acute myocardial infarction complicated by cardiogenic shock. European Heart Journal 2005; 26 (13): 1276-1283.


Illustration of the implanted

TandemHeartTM device. (Printed with permission from Cardiac Assist Inc)


IntraLase® femtosecond laser ASNZHSN News

Laser in situ keratomileusis (LASIK) has emerged to become the most common refractive surgical procedures for correcting myopia, hyperopia and astigmatism since its introduction in the early 1990s. The LASIK procedure is a two-step process, the first requires the creation of a flap of corneal tissue which is folded back. An excimer laser is then used to reshape the inner cornea to correct the vision of the patient1.

HOW IT WORKS The femtosecond laser is the first alternative to mechanical microkeratomes and the IntraLase is the first femtosecond laser approved by the FDA. The IntraLase system employs a computer-guided laser to create the corneal flap and uses an infrared beam of light to separate tissue via a process known as photodisruption (the process whereby focused laser pulses divide material at the molecular level without the transfer of heat or impact to the surrounding tissue). Unlike mechanical microkeratomes, IntraLase creates the flap below the surface of the cornea using an ‘inside-out’ process. This level of accuracy is the main reason for the purported safety of IntraLase compared to microkeratomes1.

THE EVIDENCE A retrospective case study evaluated the use of mechanical microkeratomes, using Carriazo-Barraquer (CB) (n = 126 eyes) or Hansatome (n = 146 eyes), compared with IntraLase (n = 106 eyes). 20/20 uncorrected visual acuity rates at day 1 post-surgery was slightly lower in the IntraLase group (45%) compared to CB (57%) and Hansatome (51%), but was not statistically significant. Similarly, when the 20/40 UCVA rate was considered, all three groups achieved comparable results

(98-99%). Three months after surgery, 20/20 UCVA rates were comparable in all three groups (67-71%) and 20/40 still ranged from 98-99%. Refractive predictability was significantly better for the IntraLase eyes (91%) achieving a manifest refractive spheroequivalent (MRSE) of ± 0.50 D, while the MRSE ± 0.50 D rates for CB and Hansatome were 73% (p < 0.01) and 74% (p < 0.01), respectively. All three groups achieved similar rate of MRSE ±1.00 D (95-99%). IntraLase flaps induced significantly less astigmatism compared to flaps created with CB and Hansatome (p < 0.01) possibly due to the circular (rather than truncated) shape of the IntraLase flap. No eye in the IntraLase group experienced loose epithelium. In comparison, loose epithelium was evident in 1 quadrant in 5.5% of eyes and 2 quadrants in 4.1% of eyes in the CB group, resulting in an overall rate of 9.6% (p = 0.001, compared to the IntraLase group). Meanwhile in Hansatome eyes, loose epithelium in 1 quadrant was seen in 5.1% of eyes and loose epithelium in 2 quadrants was reported in 2.6% of eyes for a total of 7.7% (p = 0.001, compared to the IntraLase group).2

Several other studies reported findings after treatment with Intralase3,4,5.

FUTURE STEPS The potential of utilising IntraLase in corneal transplantation is of significant interest, however the issues identified in the current early-stage studies reveals that further research is required before IntraLase can be utilised in clinical corneal transplantation. Based on the evidence available, HealthPACT recommended that this technology be monitored for further developments in corneal transplantation.



REFERENCES

1. Intralase Corporation. Last updated 2006. http://www.intralase.com/ [Accessed July 2006].

2. Kerizian GM, Stonecipher KG. Comparison of the IntraLase femtosecond laser and mechanical keratomes for laser in situ keratomileusis. Journal of Cataract and Refractive Surgery 2004; 30(4): 804-811.

3. Binder PS. One thousand consecutive Intralase laser in situ keratomileusis flaps. Journal of Cataract and Refractive Surgery 2006; 32(6): 962-969.

4. Lim T, Yang S, Kim M, Tchah H. Comparison of the IntraLase femtosecond laser and mechanical microkeratome for laser in situ keratomileusis. The Ameri-can Journal of Ophthalmology 2006; 141(5): 833-839.

5. T ran DB, Sarayba MA, Bor Z, Garufis C, Dyj YJ, Soltes CR, Juhasz T, Kurtz RM. Randomized prospective clinical study comparing induced aberrations with IntraLase and Hansatome flap creation in fellow eyes: potential impact on wavefront-guided laser in situ keratomileusis. Journal of Cataract and Refractive Surgery 2005; 31(1): 97-105.


Dose Verification System® for the measurement of the radiation dosage received at the tumour site in patients

with breast or prostate cancer Radiotherapy has become a conventional treatment option for patients with early and late stage cancer and its effectiveness is associated with a number of patient-level factors; including age, comorbidities, and tumour features such as location, size and aggressiveness1. The delivery of radiation according to a pre-specified treatment plan plays an important role in maximising tumour control and minimising damage to healthy tissue and accurate delivery is associated with long-term patient outcomes including survival and quality of life2. A longitudinal study (8-12 years follow-up) found that a deviation of less than 6 per cent in the cumulative dosage received by prostate cancer patients resulted in a 65 per cent change in disease free status over time3.

HOW IT WORKS The Dose Verification System® (DVS) is a wireless implantable sensor designed to target tumours and measure radiation dosages in vivo, in patients with breast and prostate cancer. Once the dosimeter is implanted in the tumour, radiation dosages are communicated telemetrically to the handheld reader system. Daily and cumulative dosages received at the site of the tumour can be reviewed using the plan and review software.

THE EVIDENCE Two in vitro studies, using readings from a DVS implanted in an acrylic phantom, compared to the true delivered dosage across a range of practical dosage levels (100 to 400 cGy). Readings from the DVS corresponded closely to the true delivered dosages, with the standard deviation of the difference ranging between 1.4 and 3.6 per cent of the value of the true dosage4,5. The DVS was implanted in 10 patients with biopsy proven malignant tumours. Each patient recruited in the study was due to receive at least four weeks of radiotherapy with a minimum daily dosage in the range of 150 to 300 cGy. Patients reported no adverse events during implantation of the device or over the follow-up period. In terms of the performance of the DVS, the difference between the expected dosage and the dosage measured at depth exceeded 8 per cent in magnitude on almost 50 per cent of occasions. Taking into account previous research demonstrating the in vitro precision of the DVS, the results suggest that the influence of confounding factors (such as organ motion, tissue heterogeneity etc) on the delivery of radiation is extensive6.

FUTURE STEPS Early studies have demonstrated that the DVS is a useful device for quantifying dosages at the site of the tumour. The ability of the DVS to monitor deviations between intended dosage and dosage received at depth suggests that the device may play an important quality assurance role in the delivery of radiotherapy. Although evidence is limited regarding the effectiveness of the DVS, the technology may play an important role in radiotherapy quality assurance. HealthPACT therefore recommended that this technology be monitored.

Written by Tom Sullivan, AHTA

REFERENCES 1. Siegelmann-Danieli, N., Khandelwal, V. et al (2006). 'Breast cancer in elderly

women: outcome as affected by age, tumor features, comorbidities, and treat-ment approach', Clin Breast Cancer, 7 (1), 59-66.

2 Emami, B., Lyman, J. et al (1991). 'Tolerance of normal tissue to therapeutic

irradiation', Int J Radiat Oncol Biol Phys, 21 (1), 109-122. 3 Hanks, G. E., Hanlon, A. L. et al (2002). 'Dose response in prostate cancer with

8-12 years' follow-up', Int J Radiat Oncol Biol Phys, 54 (2), 427-435. 4 Briere, T. M., Beddar, A. S. & Gillin, M. T. (2005). 'Evaluation of precalibrated

implantable MOSFET radiation dosimeters for megavoltage photon beams', Med Phys, 32 (11), 3346-3349.

5 Black, R. D., Scarantino, C. W. et al (2006). 'An analysis of an implantable do-

simeter system for external beam therapy', Int J Radiat Oncol Biol Phys, ac-cepted for publication 2006.

6 Scarantino, C. W., Rini, C. J. et al (2005). 'Initial clinical results of an in vivo

dosimeter during external beam radiation therapy', Int J Radiat Oncol Biol Phys, 62 (2), 606-613.


The size of a Dose Verification System compared to an American 10 cent piece. (Printed permission from Sicel Technologies, Inc)


Renessa® radiofrequency micro-remodelling treatment for female stress urinary incontinence

The Renessa radiofrequency micro-remodelling treatment is a non-surgical, transurethral treatment for women suffering stress urinary incontinence (SUI). It is used for women suffering SUI associated with bladder outlet hypermobility, with or without associated intrinsic sphincter deficiency.

HOW IT WORKS The Renessa system is a new treatment option using radiofrequency energy to perform micro-remodelling of the tissue in the urinary tract thought to be responsible for stress urinary incontinence. It is a non-surgical, transurethral treatment method previously used to treat disorders such as faecal incontinence and gastroesophageal reflux disease, which can be performed under conscious sedation. In contrast to RF tissue ablation, which uses temperatures high enough to cause tissue necrosis and is applied on a gross scale, RF micro-remodelling uses lower temperatures (65–75ºC) and is applied on a microscopic scale. RF tissue ablation creates a focal, microscopic denaturation of collagen without tissue necrosis, vascular or nerve injury, leading to micro-remodelling of selected areas of collagen upon cooling and healing. The results are 150-200 µm diameter remodelled regions with reduced dynamic tissue compliance. It is this focused micro-remodel l ing which makes RF micro-remodelling useful in the treatment of barrier function disorders such as SUI 3.

THE EVIDENCE In a 12 month multicenter RCT assessing the safety and efficacy of RF micro-remodelling on women suffering SUI associated with bladder outlet hypermobility, women were randomised to either a treatment (n = 110) or sham treatment (n = 63, with modified RF generator that did not delivery any RF emissions and a sham micro-remodelling probe with no electrodes). Women remained blinded to their treatment for the duration of the study. The treated group had micro-remodelling of 36 targets from the bladder neck to the proximal urethra. During the 12 month study period no serious adverse events were reported. Minor adverse events included dysuria, haematuria, urinary retention, urinary tract infection and a dry overactive bladder. No adverse event was statistically more prevalent in the treatment versus the sham group of patients.

At the 12 month follow-up 142 patients (89 from treatment group and 53 in sham group) (approximately 80%) were available for IQoL analysis. Twenty-nine patients were excluded due to loss of follow-up or protocol violations.

REFERENCES

1. Millard R. The prevalence of urinary incontinence in Australia. Australian Continence Journal 1998; 4(4): 92-99.

2. Women’s Health Queensland Wide Inc. Urinary Incontinence. Last updated 2004. http://www.womhealth.org.au/factsheets/urinaryincontinence.htm [Accessed August 2006].

3. Sotomayor M, Bernal GF. Transurethral delivery of radiofrequency energy for tissue micro-remodeling in the treatment of stress urinary incontinence. International Urogynecology Journal and Pelvic Floor Dysfunction 2003; 14(6): 373-379.

4. Apell RA, Juma S, Wells WG, Lenihan JP, Klimberg IW, Kanellos A, Reilley SF. Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. Neurourology and Urodynamics 2006; 25(4): 331-336.

Forty-eight percent of women in the treatment group compared to 44% of women in the sham group demonstrated ≥10 point improvement in IQoL at 12 months (NS). At follow-up women in the treatment group experienced a mean increase in leak point pressure (LPP) of 13.2 ± 39.2 cm H2O over the baseline level, while women in the sham group experienced a reduction of 2.0 ± 33.8 cm H2O over baseline levels in the same period of time (p = 0.02). This improvement in LPP, an objective measure supports the proposed mechanism of incontinence treatment on which RF micro-remodelling is based is valid4.

FUTURE STEPS The available evidence regarding the Renessa system and its method of action (RF micro-remodelling) points towards some favourable outcomes for patients undergoing this treatment. Although no serious adverse events were reported in any of the studies presented, less serious minor clinical events were reported, such as an elevated incidence of dysuria among treated patients. Further long term studies to establish the long term safety and efficacy of the device are required. HealthPACT therefore recommended that this technology be monitored.

Written by Luis Zamora, ASERNIP-S


Above: Renessa probe positioned within the bladder, with balloon inflated. (Printed Permission From Novasys Medical, Inc.)


PRODUCTION NOTES

Emerging Technology Bulletin is published by Adelaide Health Technology Assessment (AHTA) on behalf of the Health Policy Advisory Committee on Technology (HealthPACT) and funded by the Commonwealth Department of Health and Aging.

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Editor: Linda Mundy Designer: Lashan Clifton Writers/Information Specialists: Irving Lee, Linda Moyes, Linda Mundy, Luis Zamora, Thomas Sullivan, Tracy Merlin Contact: Adelaide Health Technology Assessment (AHTA) Discipline of Public Health, Mail Drop 511 The University of Adelaide Adelaide, South Australia 5005 Australia Telephone: +61 8 8303 4617 Fax: +61 8 8223 4075 www.health.adelaide.edu.au/publichealth/research/AHTA.html

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Other New and Emerging Technologies

The following technologies were archived by the Health Policy Advisory Council on Technology (HealthPACT) in September 2006. • Vivostat® system for perioperative preparation

and application of an autologous fibrin sealant.

The above technologies can be accessed on the

following link:

http://www.horizonscanning.gov.au/internet/horizon/publishing.nsf/Content/asernip-s-net-s-summaries-2

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• Nicotine metabolite ratio test measuring ratio of 3’Hydroxycotinine to cotinine to customise and improve treatment efficacy of nicotine patch therapy for smoking cessation.

• Magnetic Resonance and Transient

Elastography for the non-invasive assessment of liver fibrosis in patients at risk of liver disease.

• Pre-hospital administration of antibiotics by

paramedics for suspected cases of meningococcal infection.

• Real-time reverse transcription polymerase chain

reaction (RT-PCR) primer and probe set for the rapid detection of avian influenza (Asian lineage) in humans.

The above technologies can be accessed on the following link:

http://www.horizonscanning.gov.au/internet/horizon/publishing.nsf/Content/prioritising-summaries-2006-2

http://www.horizonscanning.gov.au/internet/horizon/publishing.nsf/Content/asernip-s-net-s-summaries-2�




http://www.horizonscanning.gov.au/internet/horizon/publishing.nsf/Content/prioritising-summaries-2006-2�




Documents

Emerging Technology Bulletin · implant for male stress urinary incontinence. Based on the lack of information from randomised, controlled trials and the potential to be an alternative