ANZHSN Bulletin -

In This Issue...

Breast-specific gamma imaging for the evaluation of women already diagnosed with breast cancer .................... 2 The Scandinavian total ankle replacement (STAR) system .......................................... 3 Renal sympathetic denervation for the treatment of resistant hypertension ............ 4 Emblocker™ ultrasonic embolic protection device for cardiac patients ......................... 5 HLA mismatched and NIMA-matched unrelated cord blood transplants ............... 6 Stomaphyx™ : Revisional bariatric surgery in obese patients ........................................... 7 Hand-held portable mini ultrasounds ........ 8 Other new and emerging technologies .... 10

Issue 14, May 2010

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

From the Chair Dear Colleagues

The Health Policy Advisory Committee on Technologies (HealthPACT) has re-ceived full funding from the Australian Health Ministers’ Advisory Council (AHMAC) to continue its work program and is currently reviewing how best it can contribute to healthcare, particularly public hospitals, with the identification of new and emerging technologies. This signifies a change in emphasis which is coming from the reporting relationship to the Clinical, Technical and Ethical Principal Committee (CTEPC), a principal committee of AHMAC

HealthPACT also discussed at length the Review of Health Technology Assessment in Australia, which focused on the processes of and the relationships between the Therapeutic Goods Administration (TGA), Prostheses and Devices Committee, the Medical Services Advisory Committee (MSAC) and the Pharmaceutical Benefits Advisory Committee (PBAC). The implementation of this report will streamline the application process for recognition of new technologies where it involves one or more of these activities and hopefully reduce both duplication of effort and time in assessing these new technologies. The Review also recommended that the Austra-lian Health Ministers' Conference (AHMC) be asked to consider a national ap-proach to HTA processes including improved planning and system integration and links with other aspects of the Australian Healthcare System, particularly the States and Territories Healthcare, as well as greater patient focus, increased investment in HTA-related research and increased capacity for the HTA workforce. These mat-ters will be progressed and considered by the AHMAC later on this year. Three post market surveillance recommenda-tions are subject to further consideration by Government due to the financial im-plications of implementing them.

There are significant developments in health technology assessment across several States, including Victoria, Queensland and Western Australia, and it is likely that the shift towards implementation and evaluation of new and emerging technologies could be a major focus for HPACT.

Yours sincerely

Brendon Kearney Chair of HealthPACT

Breast-specific gamma imaging (BSGI), also known as molecular breast imaging (MBI) or scintimammography, has previously been assessed as a potential method for screening asymptomatic women in the report “New and emerging technologies for breast cancer detection”. This summary seeks to more fully assess the use of BSGI to evaluate women already diagnosed with breast cancer.

HOW IT WORKS BSGI is an invasive procedure and uses the radiopharmaceutical and perfusion imaging agent, 99mtechnetium-sestamibi (99mTc-sestamibi) (1). Cancerous cells use high levels of energy compared to healthy cells and have hyperactive mitochondria. Compared to the healthy surrounding cells, cancerous cells will take up increased levels of 99mTc-sestamibi and emit more gamma rays, and will show up on the captured images as regions of brightness (2).

THE EVIDENCE Four studies were included for assessment in this summary. Only the results from one study are described here, the remaining information and data tables can be obtained from the Horizon Scanning web site.

Single and dual-head BSGI systems were used to investigate 100 and 150 women, respectively, with suspicious breast lesions identified by mammography and/or ultrasound (3). All women underwent biopsy after MBI was performed and MBI results were compared to pathology results from core needle biopsy or surgical excision (level III-1 diagnostic evidence).

Of the 100 women in the single-head BSGI study, 47 had benign findings and 53 had breast cancer later confirmed at surgery. In these 53 women, 59 tumours were identified by mammography and/or ultrasound. Although BSGI identified eight tumours in seven patients not detected by mammography, it gave false negative results for 10 tumours in seven patients (sensitivity 57/67, 85%). Possible reasons for

ANZHSN Bulletin

Scintimammograms or breast-specific gamma imaging for the evaluation of women diagnosed with breast cancer

2. Issue 14 May 2010

the false negative results included five patients with small tumours (<5mm). In addition, all seven patients had large breasts and technical problems, including poor patient positioning (n=5) and low 99mTc-sestamibi uptake (n=5) may have had an impact on results.

In the dual-head BSGI study, 62 of the 150 women were benign for breast cancer. A total of 128 tumours were detected in the 88 women found to have breast cancer. Of these, 119 were identified with mammography or ultrasound and a further nine were detected with BSGI. The dual-head detector was more sensitive (91%) than the single-head, identifying 117 of the 128 tumours with eleven false negatives reported.

Single-head BSGI had the greatest sensitivity for detecting larger tumours (>10mm, 97%), however, sensitivity was greatly improved for the detection of smaller tumours (<10mm) when a dual-head detector was employed.

.FUTURE STEPS Based on the evidence available BSGI appears to be useful in the pre-surgical evaluation of women with biopsy-proven breast cancer when used as an adjunct with other imaging modalities including mammography, ultrasound and MRI. Therefore HealthPACT have recommended that a Horizon Scanning Report be commissioned .

REFERENCES

1. Taillefer, R. (2005). 'Clinical applications of 99mTc-sestamibi scintimammo graphy', Semin Nucl Med, 35 (2), 100-115.

2. Schmidt, C. (2008). 'Molecular breast imaging: potential new tool for detecting cancers', J Natl Cancer Inst, 100 (22), 1568-1570.

3. Hruska, C. B., Boughey, J. C. et al (2008). 'Scientific Impact Recognition Award: Molecular breast imaging: a review of the Mayo Clinic experience', Am J Surg, 196 (4), 470-476.

4. Dilon Diagnostics (2009). What is BSGI? What is MBI? [Internet]. Available from: http://www.dilon.com/pages/bsgi___molecular_breast_imaging/34.php [Accessed 18th December].

Positioning of the gamma camera in the caudal, oblique and medial views (4)

Written by Linda Mundy (AHTA)

The Scandinavian Total Ankle Replacement (STAR) system provides patients with painful arthritic ankle joints with uncemented ankle replacement when conventional treatment has failed, as a realistic alternative to arthrodesis, with the aim of providing pain relief and improved mobilisation.

HOW IT WORKS The STAR system is a 2-component anatomic unconstrained resurfacing ankle prosthesis with congruent parts covering the medial and lateral facet joints. From 1986, the tibial compo-nent of the STAR system included a polyethylene meniscus, which was intended to minimise rotational stress forces on the implant-bone interface. The device was further improved so that the prosthesis was used with a bioactive surface for uncemented implantation (1). These 2 changes gave rise to the 2nd-generation STAR system prosthesis. The metallic components of the 2nd-generation STAR system prosthesis are made of cobalt-chromium alloy. These metal components are coated with a thin layer of titanium (300mm, pore size 75-200mm, porosity 25-35%), and a hydroxyapatite layer (25mm thick, porosity 60%). The prosthesis comprises of a tibial component, talar component, and meniscal components (2). The potential benefit of the STAR system may include the ability to preserve some range of motion in the foot by closely imitating the function of the natural ankle.

THE EVIDENCE Only one study compared the STAR system to the current gold standard, ankle arthrodesis (3). Results of the remaining 3 studies assessed may be accessed via the HS web site.

Patients with noninflammatory arthritis underwent treatment with either the STAR device (n=42) or ankle fusion (n=29) using cannulated screws (n=14), plates and screws (n=10), or external fixators (n=3) were retrospectively reviewed. Foot function was evaluated using the Ankle Osteoarthritis Scale (AOS) for pain and disability. Radiographic outcomes were assessed using the Kellgren/Lawrence (K/L) arthritis scale.

Additional postoperative procedures were carried out in 41% and 22% of patients in the STAR and fusion groups, respectively. Reoperation in the STAR group occurred for indications including lateral or posterior impingement, exostosis, osteolysis and non-union. Also in the STAR group there were 5 intraoperative medial or posterior malleolar fractures that were fixed internally at the index operation., 2 patients developed DVT, and one developed superficial wound

dehiscence. Of the fusion patients indications for reoperation included non-union, hardware pain, and naviculocuneiform joint arthritis progression. Other complications in the fusion group that were treated without the need for surgery included leg length discrepancy, delayed union, tibia stress fracture, hardware pain and wound dehiscence, and impingement.

A significant difference in postoperative SF-36 (mental component summary) score was reported between patients in the STAR and fusion groups, with a higher score (better mental function) achieved in STAR patients (46 vs 40, p=0.011). AOS-pain scores were also significantly different between the groups, with less pain experienced in STAR patients compared with fusion patients (26 vs 51, p=0.001). Other clinical outcomes measures, including SF-36 physical component summary score and AOS-disability score were not significantly different for patients undergoing STAR or ankle fusion. K/L arthritis grade was recorded at the subtalar, talonavicular, calcaneocuboid and midfoot for both pre- and post-operative radiographic assessment. There was no significant difference in pre- or postoperative osteoarthritis between the STAR and fusion groups at any joint evaluated. There was also no significant difference in the change in osteoarthritis (pre- to post-operative) between the 2 groups.

.FUTURE STEPS Given the increasing debate regarding the use of uncemented or cemented joint replacement procedures, it is recommended that a Horizon Scanning Report be written to explore these procedures in greater detail.

Written by Deanne Leopardi (ASERNIP-S)

ANZHSN Bulletin

The Scandinavian total ankle replacement (STAR) system for patients with painful arthritic ankle joint

May 2010 Issue 14 3.

REFERENCES

1. Kofoed H. Scandinavian Total Ankle Replacement (STAR). Clin Orthop Relat Res 2004; (424): 73-79.

2. Anderson T, Montgomery F, Carlsson A. Uncemented STAR total ankle prostheses. J Bone Joint Surg Am 2004; 86-A Suppl 1(Pt 2): 103-111.

3. Saltzman CL, Kadoko RG, Suh JS. Treatment of isolated ankle osteoarthritis with arthrodesis or the total ankle replacement: a comparison of early outcomes. Clinics in Orthopedic Surgery 2010; 2(1): 1-7.

denervation took place and treatment was aborted. MRI renal angiograms conducted at short-term follow-up (n=18) and at six months (n=14) did not detect any abnormalities at the treatment location.

Effectiveness

Both systolic and diastolic blood pressures were significantly lower at end of follow-up compared to baseline (p=0.026 and p=0.027, respectively). At all time points at follow-up, both the systolic and diastolic blood pressures were statistically significantly lower than at baseline (p<0.001 and p=0.02 for the 12-month diastolic measure). Six of the treated patients had systolic blood pressure reductions of less than 10 mm Hg and were therefore considered non-responders. Full data can be obtained from the Horizon Scanning web site.

The five patients excluded before treatment commenced recorded a mean, but not significant, increase in blood pressure at one, three, six and nine months. During the course of the study some patients increased or decreased the antihypertensive medication they were taking. The decrease in systolic and diastolic blood pressure was maintained after data were censored for these patients (no p values reported).

.FUTURE STEPS Renal denervation appears to be an innovative and promising technique for the treatment of resistant hypertension. HealthPACT have recommended that further information from clinical trials be assessed in 24-months time.

Written by Linda Mundy (AHTA)

ANZHSN Bulletin

Renal sympathetic denervation for the treatment of resistant hypertension

4. Issue 14 May 2010

Renal sympathetic denervation is a novel procedure which aims to reduce elevated blood pressure in patients with resistant hypertension. Resistant hypertension is defined as persistent high blood pressure despite treatment with three antihypertensive agents of different classes.

HOW IT WORKS The kidney plays a vital role in the regulation of blood pressure (sodium filtration, blood volume etc) and renal sympathetic nerve hyperactivity (both afferent and efferent) has been demonstrated to be a major factor in the pathophysiology of hypertension (1, 2). The renal sympathetic efferent nerves innervate the renal tubules, vasculature and juxtaglomerular apparatus and may affect volume and blood homeostasis. In animal models, denervation of the renal nerves has been demonstrated to delay the development of induced hypertension and to increase sodium excretion (3).

Denervation was achieved via the ablation of sympathetic nerve fibres using low-dose radiofrequency energy delivered to the renal artery endothelial surface via a percutaneous catheter. The catheter is introduced via the femoral artery and up to 6 ablations of 2-minutes duration are performed (1, 4).

THE EVIDENCE The proof-of-concept study conducted by Krum et al (2009) enrolled hypertensive patients (n=50, mean age 58 ± 9 years) who satisfied the selection criteria of an office-based systolic blood pressure of ³160 mm Hg, despite being treated with at least three anti-hypertensive medications, including one diuretic. Follow-up was performed at 1, 3, 6, 9 and 12-months with a renal MRI angiogram performed again at 6-months. The primary outcomes were the safety of the technique and the effectiveness of it to lower blood pressure.

Safety

Most patients experienced non-radiating abdominal pain during the procedure and were administered intravenous narcotic and sedative drugs. Pain did not persist after the denervation procedure.

Two patients experienced complications with the procedure. One patient developed a pseudo-aneurysm at the femoral artery site where the catheter was introduced which was treated with analgesics and antibiotics without further complication. The other patient experienced renal artery dissection when the catheter was introduced which was detected before

REFERENCES

1. Katholi, R. E. & Rocha-Singh, K. J. (2009). 'The role of renal sympathetic nerves in hypertension: has percutaneous renal denervation refocused attention on their clinical significance?', Prog Cardiovasc Dis, 52 (3), 243-248.

2. Schlaich, M. P., Sobotka, P. A. et al (2009). 'Renal denervation as a therapeutic approach for hypertension: novel implications for an old concept', Hypertension, 54 (6), 1195-1201.

3. Bravo, E. L., Rafey, M. A. & Nally Jr, J. V. (2009). 'Renal Denervation for Resistant Hypertension', American Journal of Kidney Diseases, 54 (5), 795-797.

4. Krum, H., Schlaich, M. et al (2009). 'Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study', Lancet, 373 (9671), 1275-1281.

ANZHSN Bulletin

Emblocker™ ultrasonic embolic protection device The EmBlocker (ultrasonic embolic protection) device is used during cardiac surgery to divert emboli generated by surgical manipulations away from the innominate and left common carotid arteries and into the descending aorta..

HOW IT WORKS EmBlocker works on the principle that an object with different acoustic impedance than its surroundings partly reflects/absorbs ultrasound energy. Red and white blood cells and their surroundings have very little acoustic difference whereas emboli have a greater acoustic difference with their surround-ings; therefore, ultrasonic radiation will have no affect on blood cells and a greater affect on emboli. Gaseous emboli have a greater difference in acoustic impedance with their sur-roundings compared with solid emboli; therefore, a lower ul-trasonic energy level (0.5 W/cm2) is sufficient to achieve the same acoustic radiation force on gaseous emboli as a higher ultrasonic energy level (1.5 W/cm2) on a solid emboli (1). The EmBlocker device delivers ultrasonic energy which is absorbed by the emboli in the form of acoustic radiation force, resulting in the diversion of the path of the emboli.

The EmBlocker device consists of an oval shaped 2.2 MHz disposable transducer. After thoracotomy, the EmBlocker device is placed on the ascending aorta at the point where the innominate artery emerges (1). A biocompatible dome filled with saline is placed over the transducer to keep it cool and to prevent air seeping between the device and the tissue. Temperature sensors ensure that the transducer does not overheat (2).

THE EVIDENCE Patients (n=21) undergoing a heart valve procedure (with or without coronary artery bypass grafting) were enrolled in a comparative pilot study (2). The experimental group (n=11) had the EmBlocker device positioned and activated for 1

minute at an intensity of 1.5 W/cm2 during 7 selected aortic manipulations and for 10 minutes at an intensity of 0.5 W/cm2 intermittently after cross clamp removal. One patient in the experimental group was excluded due to technical problems with the device. The control group (n=10) had the EmBlocker console put in place to simulate use, however it was not activated. All patients

were monitored intraoperatively for microembolic signals (MES) with bilateral transcranial Doppler of the middle cerebral arteries. The readings were manually examined for the absence or presence of MES independently by 2 physicians blinded to treatment allocation.

No safety issues were reported.

In all selected manipulations the number of MES was lower in patients in the EmBlocker group compared with the control group. During aortic manipulations, MES were 63% lower when the EmBlocker was used (p<0.05). The overall number of cerebral MES was also significantly lower in the EmBlocker group compared with the control group (53% reduction, p<0.05). There was no significant difference in the number of MES detected in the left and right middle cerebral arteries in either group.

There were fewer MES detected during the air removal phase in the EmBlocker group (left artery 133 MES; right artery 119 MES) compared with the control group (left 252 MES; right 266 MES), although the difference was statistically non-significant. This may be due to the variation in the time between release of the cross clamp and decannulation. The counting method used may underestimate the counted MES when the density of emboli is high because the size of the segments (200 ms) restricts the number of counted MES per second to five.

In the EmBlocker group, the reduction of MES detected in the right middle cerebral artery was slightly higher than for the left artery (54% versus 49%). This may be due to some of the microemboli that were diverted away from the innominate artery appearing in the left common carotid artery.

.FUTURE STEPS Based on the limited available evidence and the potential benefit of this technology it is recommended that the Emblocker and all other potential ultrasonic embolic protective devices be monitored for 12 months.

Written by Deanne Leopardi (ASERNIP-S)

May 2010 Issue 14 5.

REFERENCES

1. Sauren LDC, la Meir M, Palmen M, Severdija E, van der Veen FH, Mess WH Maessen JG. New ultrasonic radiation reduces cerebral emboli during extracorporeal circulation. European Journal of Cardio-Thoracic Surgery 2007; 32(2): 274-280. (Animal study)

2. Sauren LDC, la Meir M, Bolotin G, van der Veen FH, Heijmans JH, Mess WH, Maessen JG. The EmBlocker: efficiency of a new ultrasonic embolic protection device adjunctive to heart valve surgery. The Annals of Thoracic Surgery 2009; 88(1): 253-257.

Human leukocyte antigens (HLA) matched haematopoietic stem cell transplantation is a common method to treat haematological malignancies., however, many patients fail to find a suitable matched donor.

HOW IT WORKS The advantage of using cord blood stem cells is there can be a greater HLA disparity between donor and recipient when compared to using unrelated donors of bone marrow (1). The disadvantage of cord blood transplants is, however, a higher incidence of graft failure compared to conventional bone marrow transplants. This is slightly offset by a reduced risk of acute and chronic graft-versus-host disease (2). When using unrelated donors, HLA matching is considered to be the most important factor for transplantation success. During pregnancy there is a two-way flow of cells and molecules, including soluble HLA antigens, between the mother and the foetus, with the foetus subsequently developing immunity and tolerance. Studies have demonstrated that some patients who have antibodies against a large number of HLA antigens have not formed antibodies against maternal HLA antigens that the patient did not inherit as part of their genetic make-up, that is the non-inherited maternal antigens (NIMA). It has been suggested that a reduced level of graft-versus-host disease and hence improved transplantation outcomes, may occur despite HLA mismatches if donors are matched for NIMA (1, 3). Using cord blood samples with NIMA mismatches may potentially increase the size of the potential donor pool, increasing the chances of finding a donor.

THE EVIDENCE A large retrospective case series reported on the outcomes of 1,121 patients transplanted with a single cord blood (CB) unit. There was no a priori matching of NIMA, however some patients did receive CB with matched NIMA and unmatched HLA serendipitously.

Only 62 patients (5.5%) received a matched CB transplant. Of the remaining 1,059 patients, 79 had a mismatched antigen that was identical to a donor NIMA, 25 (2.2%) of whom received CB with one HLA mismatch and 54 (4.8%) had two HLA mismatches. Of the NIMA mismatched patients there were 363 (32%) patients with one HLA mismatch and 617 (55%) with two HLA mismatches.

A multivariate analysis of the relative risk of all the study end-points was conducted in patients undergoing transplantation

with zero, one or two HLA mismatches, by match for a non-inherited maternal antigen. Despite low patient numbers in each of the sub-analyses groups, there were some significant differences between HLA mismatched patients with NIMA matching compared to those without NIMA matching. Full data can be obtained from the Horizon Scanning web site.

The 3-year cumulative probability of transplant-related mortality was 46% and was lower in the NIMA matched patients than in the non-NIMA matched pairs (relative risk 0.7, 95% CI [0.5, 0.97], p=0.034). This effect was strengthened when patients were stratified for age, as there was a significant decrease in transplant-related mortality in patients older than 10 years who had one HLA mismatch (RR 0.6, 95% CI [0.4, 0.99], p= 0.048) or zero or more HLA mismatches (RR 0.6, 95% CI [0.3, 0.9], p=0.012). A similar improvement was reported in patients older than 10 years for overall mortality (RR 0.6 95% CI [0.4, 0.9], p=0.022) and transplant failure (RR 0.6 95% CI [0.4, 0.9], p=0.02).

.FUTURE STEPS This technology appears to be slowly diffusing into Australia and New Zealand. HealthPACT have agreed to disseminate this information to the relevant bodies including the Australian Bone Marrow Donor Registry’s Cord Blood National Management Committee. No further review by HealthPACT is required.

Written by Linda Mundy (AHTA)

ANZHSN Bulletin

HLA mismatched and NIMA-matched unrelated cord blood transplants

REFERENCES

1. van Rood, J. J., Stevens, C. E. et al (2009). 'Reexposure of cord blood to nonin-herited maternal HLA antigens improves transplant outcome in hematological malignancies', Proc Natl Acad Sci U S A, 106 (47), 19952-19957.

2. Wall, D. A. & Chan, K. W. (2008). 'Selection of cord blood unit(s) for transplan-tation', Bone Marrow Transplant, 42 (1), 1-7.

3. Scaradavou, A. (2010). 'Unrelated umbilical cord blood unit selection', Semin Hematol, 47 (1), 13-21.

StomaphyX is a novel single-use surgical device utilised for tissue approximation and ligation in the gastrointestinal tract. Its applications include revision bariatric surgery and repair of gastric leaks.

HOW IT WORKS Postoperative complications (e.g. motility and acid secretion problems) and inadequate long-term weight control may lead to the failure of primary bariatric surgery for obesity (1). Revision surgery can be technically challenging and associated with high risk as patients may present with uncorrected serious co-morbidities. In addition, there is the possibility that patients may have extensive abdominal adhesions, ulcers, inflammation, bowel obstructions, metabolic disturbances and other severe physiological problems attributed to primary surgery (2). These factors will contribute to postoperative complications and therefore lead to undesirable outcomes after revision surgery (3-6). The StomphyX is a natural orifice transluminal surgical (NOTES) device developed for transoral tissue connection and ligation within the gastrointestinal tract using SerosaFuse™ fasteners. These propopylene H fasteners are capable of creating full-thickness, serosal-to-serosal tissue approximations. StomaphyX has been used to reduce the volume of the small stomach pouch created during primary bariatric procedures such as Roux-en-Y or gastric bypass surgery which may have stretched over time (7) and for repair of gastric leaks during reoperation (8).

THE EVIDENCE A small case series discussed their experience on the use of StomaphyX to decrease the size of gastric pouches after Roux-en-Y gastric bypass (7). All patients (n=39) were at least

2-years post-gastric bypass surgery and had gained 10% of their lowest nadir weight. An average of 17 fasteners (range 12-41) were placed with StomaphyX during the procedure. All patients were instructed to maintain a liquid diet for 2-weeks, followed by 6 small meals per day after 2 weeks.

At 2-weeks, average weight loss was 3.8kg (7.4% excess bodyweight loss EBWL) n=39), at 1-month it was 6.4kg (10.6% EBWL; n=34), at 2-months it was 6.7kg (13.1%

EBWL; n=26), at 3-months it was 6.7kg (13.1% EBWL; n=15), at 6 months it was 8.7kg (17.0% EBWL; n=14) and at 1-year it was 10.0kg (19.5% EBWL; n=6). No major adverse events were observed. The authors reported that 87.2% of patients experienced sore throats lasting less than 48 hours while 76.9% experienced epigastric pain that lasted several days. All patients described a feeling of increased early satiety 2-weeks post-procedure. Unexpected results were noted in 11 patients after the StomyphyX procedure but 8 patients with a history of gastric oesophageal reflux experienced improvement of symptoms at 1-month. This effect has been noticed in other plication procedures and the formation of pleats near the gastroesophageal junction may have increased the robustness of the oesophageal valve. Meanwhile, 3 patients with late dumping syndrome after their original gastric bypass had their postprandial diarrhoea resolved.

The results of several case reports reported by Overcash (2008) may be accessed via the horizon scanning web site.

.FUTURE STEPS With the limited evidence available it is difficult to make a conclusive statement regarding the effectiveness of StomaphyX. Preliminary evidence indicates that it has the potential to address the need for revision bariatric surgery. It is recommended that StomaphyX and other NOTES techniques for revision bariatric surgery be monitored for 24-months to gather additional data and to observe the diffusion of NOTES in bariatric surgery.

Written by Irving Lee (ASERNIP-S)

ANZHSN Bulletin

Stomaphyx™: Revisional bariatric surgery

REFERENCES

1. Gumbs AA, Pomp A, Gagner M. Revisional bariatric surgery for inadequate weight loss. Obesity Surgery 2007; 17(9): 1137-1145.

2. Hallowell PT, Stellato TA, Yao DA, Robinson A, Schuster MM, Graf KN. Should bariatric revisional surgery be avoided secondary to increased morbidity and mortality? American Journal of Surgery 2009; 197(3): 391-396.

3. Cates JA, Drenick EJ, Abedin MZ, Doty JE, Saunders KD, Roslyn JJ. Reopera-tive surgery for the morbidly obese. A university experience. Archive of Surgery 1990; 125(10): 1400-1403.

4. Roller JE, Provost DA. Revision of failed gastric restrictive operations to Roux-en-Y gastric bypass: impact of multiple prior bariatric operations on outcome. Obesity Surgery 2006; 16(7): 865-869.

5. Sugerman HJ, Wolper JL. Failed gastroplasty for morbid obesity. Revised gastro-plasty versus Roux-Y gastric bypass. American Journal of Surgery 1984; 148(3): 331-336.

6. Gagner M, Gentileschi P, de Csepel J, Kini S, Patterson E, Inabnet WB, Herron D, Pomp A. Laparoscopic reoperative bariatric surgery: experience from 27 consecutive patients. Obesity Surgery 2002; 12(2): 254-260.

7. Mikami D, Needleman B, Narula V, Durant J, Melvin WS. Natural orifice sur-gery: initial US experience utilizing the StomaphyX device to reduce gastric pouches after Roux-en-Y gastric bypass. Surgical Endoscopy 2010; 24(1): 223-228.

8. Overcash WT. Natural orifice surgery (NOS) using StomaphyX for repair of gastric leaks after bariatric revisions. Obesity Surgery 2008; 18(7): 882-885.

May 2010 Issue 14 7.

Hand-held portable mini ultrasounds median of 3-days post-transplantation. A total of 86 (43 paired) US examinations were performed. Total examination time was significantly longer (p<0.01) with the hand-held US compared to conventional US. With the hand-held US, 20 examinations (47%) lasted between 20-30 minutes and nine (21%) lasted longer than 30 minutes. Using conventional US, 14 (33%) examinations lasted between 20-30 minutes and none were greater than 30 minutes. This result was independent of operator. The quality of the grey-scale images was significantly lower with the hand-held US compared to conventional US (42% vs 74% of images graded excellent respectively, p<0.0001). However, the diagnostic accuracy of the hand-held US was high in comparison to conventional US for the detection of ascites or pleural effusions (sensitivity 93%, specificity 93%) and abdominal fluid collections (sensitivity 93%, specificity 100%).

Abdominal fluid collections in 2 patients were missed by hand-held US, which may be a reflection of lack of training. Ten pleu-ral effusions were detected by both conventional and hand-held US. Both US devices failed to detect patency in the right hepatic vein after 3 examinations, which was later detected by CT. Apart from this case both devices detected patency in the portal branches, hepatic veins and inferior vena cava. Similarly, both devices failed to detect a signal in the right or left branch of the hepatic artery or in the hilum in 4 patients, later detected by CT. In 2 cases the hand-held US failed to detect a signal in the he-patic artery and in one case the hilum, which were all detected by the conventional US. There was poor agreement between the hand-held and conventional US for the systolic ascension time and the resistive index. Although the hand-held US did not appear to be as effective in assessing liver transplant patients, the authors consider that the technology will continue to improve at a rapid rate, making it a viable option.

.FUTURE STEPS There is a clear clinical need for hand-held US devices especially in emergency situations. The technology is advancing rapidly and many clinicians may choose to use a hand-held device as an adjunct to clinical decision making. It is likely that this technology will diffuse naturally into the Australasian health scene and hospitals and/or clinicians will make individual decisions whether or not to purchase this device. Feedback from the introduction of these devices into the Queensland Ambulance Service will be assessed, however in the short-term no further review by HealthPACT on this technology is required.

Written by Linda Mundy (AHTA)

ANZHSN Bulletin

8. Issue 14 May 2010

Hand-held personal ultrasound devices aim to provide a rapid response and immediate diagnostic information. It is envisaged that this technology would be used in ambulance services, emergency rooms and for point-of-care examinations.

HOW IT WORKS Hand-held personal US devices such as the Signos, are palm-sized and comprise of a touch screen and probe., weighing approximately 300 grams. The device can be worn around the neck like a stethoscope or carried in the pocket. The body of the device

has a mini-USB port, a headphone jack, an AC adapter connec-tion and a micro-SD slot (2GB) for the downloading of images. The device has a high resolution touch screen (240 x 320 pix-

els) and can operate with 2 interchangeable transducers: 3.5 MHz or 7.5MHz, bothsingle crystal (1, 2). The software allows linear caliper measurements, the editing of patient information and a review of images (1). The Signos has a scanning depth of 0.3 to 18 cm depending on the type of transducer used. The battery can be charged via the power supply, USB connection or car charger. It takes approximately 3-hours to fully charge the battery which then has a life span of 60 minutes of continuous scanning, or 12-hours with 4 typical one-minute scans per hour (2).

THE EVIDENCE No studies described the use of hand-held US devices in clinical practice. Three studies were identified that described the use of a previous generation of compact, portable, lightweight USs which are the size of a small laptop. Only the results from 1 of these studies will be presented in this newsletter, the other studies may be accessed via the Horizon Scanning web site.

A hand-held US was used to examine adult patients who had recently undergone a liver transplant for end-stage liver disease (3). Complications in these patients include stenosis, thrombosis or pseudo-aneurysms of the hepatic artery and occur in 8-10% of transplant patients. Routine US may be difficult in an intensive care environment due to limitations of space. Patients underwent paired examinations with a hand-held US (GE LogiqBook XP) and conventional portable US, both with a transducer frequency of 3.5 MHz.

Consecutive liver transplant patients (n=24) were examined a

ANZHSN Bulletin

Recently several members of HealthPACT and the evaluators from the ANZHSN, in conjunction with many members of EuroScan network, took part in an assessment process for innovative technologies that address global health concerns under the auspices of the World Health Organization. The WHO recently launched the Global Initiative on Health Technologies with the goal of making the benefits of core technologies available at an affordable price, particularly to communities in resource-limited settings, in order to effectively control important health problems. Applications were submitted to the WHO for innovative medical devices and technologies, either commercialisable or at an earlier stage of development, which were deemed likely to be accessible, appropriate and affordable for use in low- and middle-income countries.

In 2009, the WHO’s Advisory Group on Innovative Technologies called for submissions for technologies which addressed particular health areas including malaria, HIV/ AIDS, prematurity and low birth weight, and neonatal infections. For more information please see the brochure “Innovative Technologies that Address Global Health Concerns”. WHO internal experts screened all eligible applications and those that were successful were forwarded to external independent experts for evaluation using the following criteria to guide their assessments:

Level of safety for the user, patient and the environment;

How effectively the technology addresses the health concern in question;

How well the technology is adapted to local infrastructures in resource-limited settings;

Ease of use and maintenance;

Total cost of ownership, cost-effectiveness and affordability; and

Cultural and social acceptability of the technology.

Points were awarded for each category and tallied at the end of the assessment. Technologies were also evaluated simultaneously and independently by internal WHO staff and other external agencies. The 14 agencies or individuals associated with EuroScan agreed to evaluate a total of 68 technologies, with each evaluator assessing 10 technologies. To ensure quality control in the evaluations, each technology was evaluated by two agencies and the results of these evaluations pooled and collated by the Secretariat of EuroScan. Evaluations were sent back to the Advisory Group on Innovative Technologies and the five technologies which obtain the highest points in the two categories, Commercialised and non-commercialised will be presented to the AGIT meeting in late April 2010. All of the Australian evaluators found this to be an interesting and rewarding experience and that it was a good way to forge some important links with a large organisation such as the WHO and an important initiative for global health.

May 2010 Issue 14 9.

References: Hand-held portable mini ultrasounds

1. Li, J. (2009). 'Ultrasound for the Masses', Emergency Medicine News, 31 (9), 10, 12-13.

2. Signostics Pty Ltd (2009). Signos Personal Ultrasound [Internet]. Signostics Pty Ltd. Available from: http://www.signosticsmedical.com/documents/D02612_Signos_Brochure_AU.pdf [Accessed 1st February].

3. Trinquart, L., Bruno, O. et al (2009). 'A hand-held ultrasound machine vs. conventional ultrasound machine in the bedside assessment of post-liver transplant patients', Eur Radiol, 19 (10), 2441-2447.

News Flash

PRODUCTION NOTES

The ANZHSN Bulletin is published by Adelaide Health Technology Assessment (AHTA) on behalf of the Health Policy Advisory Committee on Technology (HealthPACT) and funded by the Australian Government Department of Health and Ageing.

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Editor: Linda Mundy Design: Lashan Clifton Writers/Information Specialists: Deanne Leopardi, Linda Mundy, Ben Ellery, Caryn Perera, Janet Hiller, Irving Lee. Contact: Adelaide Health Technology Assessment (AHTA) Discipline of Public Health, Mail Drop DX 650 545 The University of Adelaide Adelaide, South Australia 5005 Australia email: ahta@adelaide.edu.au Tel: +61 8 8303 4617 Fax: +61 8 8303 6899 www.adelaide.edu.au/ahta

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WE VALUE YOUR FEEDBACK!

Please forward Newsletter feedback to:

Lashan Clifton

Tel: +61 8 8303 4617

Email: lashan.clifton@adelaide.edu.au

Contact us with medical or surgical technologies,

procedures, or health programs that are new or

emerging in Australia.

Please forward to: Linda Mundy

Tel: +61 8 8303 6256

Email: linda.mundy@adelaide.edu.au

Other New and Emerging Technologies

The following additional technologies were considered by the Health Policy Advisory Committee on Technology (HealthPACT) in April 2010. Home Ultraviolet B (UVB) phototherapy for the treatment

of severe psoriasis

MRI-safe incubator for the safe imaging of premature infants

Autologous stem cell transplantation for the regeneration of insulin-producing pancreatic cells in Type-1 diabetics

Cytochrome P450 test to establish the correct warfarin dose in patients requiring oral anticoagulant therapy

Screening for lung cancer with CT [evidence update]

LIPOchip® for the genetic diagnosis of familial hypercholesterolaemia [evidence update]

T-Stat ischaemia detection system [evidence update]

ReCell®system for patients requiring epidermal replacement

Transaxial anterior lumbar interbody fusion (AxiaLIF™) for patients with back pain

Laparoscopic diaphragm pacing stimulation system to provide ventilator support in patients with diaphragm dysfunction

Shock wave therapy for wound healing for patients with soft tissue wounds [evidence update]

Serial transverse enteroplasty to lengthen the small intestine in patients with short bowel syndrome [evidence update

EsophyX™ system for the treatment of symptomatic chronic gastro-oesophageal reflux disease in patients responsive to pharmacological therapy

Further information on the health technologies included

in the Bulletin can be accessed on the following link: http://www.horizonscanning.gov.au

ANZHSN Bulletin

10. Issue 14 May 2010