8
Health Technology Update covers a cross section of new or innovative health technologies that may or may not have Health Canada approval. Some of the technologies may already be licensed for use in the US or elsewhere, while others are being used only in clinical trials. Some not-so-new technologies are already licensed for use in Canada, but high costs or other factors may be influencing their rate of uptake and diffusion. We hope that you will find this issue of the Health Technology Update informative and useful. In this issue: 2 Telepharmacy, an application of telemedicine that helps bring pharmacy services to remote areas. First practised in British Columbia in 2003, telepharmacy is now expanding elsewhere in Canada. 3 Gamma Knife ® , a stereotactic radiosurgery unit that uses beams of radiation rather than a surgical incision to destroy lesions in the skull. This technology was developed several decades ago but has only been available in Canada since 2003. 4 Celacade, TM an immune modulation therapy for chronic heart failure. Clinical trials of this technology are underway in the US and Canada. 5 TempTouch ® , a foot thermometer to help people with diabetes identify "hot spots" on the feet before ulcers break through the skin. Although not yet available in Canada, TempTouch received US Food and Drug Administration licensing approval in 2005. 6 Drug-eluting stents, a treatment for blocked arteries in the legs. Not yet approved anywhere in the world, these stents are being evaluated in clinical trials. 7 Safe-Cross ® RF System, a minimally invasive technology that uses radiofrequency energy to clear totally blocked coronary arteries. A newsletter on new and emerging health care technologies in Canada Scanning the horizon Informing decision makers about emerging medical technologies Issue 2 January 2006 We would be delighted to have your feedback and suggestions for new technologies to review in future issues of the newsletter. Please send comments to: Catherine Allison, Editor. E-mail: [email protected] Although this technology was licensed by Health Canada in 2003, it has not yet been used in clinical practice here. 8 New and emerging health technology reports, a listing of recent publications from several health technology assessment agencies

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Page 1: Scanning the horizon - CADTH.ca · A newsletter on new and emerging health care technologies in Canada Scanning the horizon Informing decision makers about emerging medical technologies

Health Technology Update covers a crosssection of new or innovative healthtechnologies that may or may not haveHealth Canada approval. Some of thetechnologies may already be licensed foruse in the US or elsewhere, while othersare being used only in clinical trials.Some not-so-new technologies arealready licensed for use in Canada, buthigh costs or other factors may beinfluencing their rate of uptake anddiffusion.

We hope that you will find this issue ofthe Health Technology Updateinformative and useful.

In this issue: 2 Telepharmacy, an application of

telemedicine that helps bringpharmacy services to remote areas.First practised in British Columbia in 2003, telepharmacy is nowexpanding elsewhere in Canada.

3 Gamma Knife®, a stereotacticradiosurgery unit that uses beams ofradiation rather than a surgicalincision to destroy lesions in theskull. This technology wasdeveloped several decades ago buthas only been available in Canadasince 2003.

4 Celacade,TM an immune modulationtherapy for chronic heart failure.Clinical trials of this technology are underway in the US and Canada.

5 TempTouch®, a foot thermometer tohelp people with diabetes identify"hot spots" on the feet before ulcersbreak through the skin. Although notyet available in Canada, TempTouchreceived US Food and DrugAdministration licensing approvalin 2005.

6 Drug-eluting stents, a treatment forblocked arteries in the legs. Not yetapproved anywhere in the world,these stents are being evaluated inclinical trials.

7 Safe-Cross® RF System, a minimallyinvasive technology that usesradiofrequency energy to cleartotally blocked coronary arteries.

A newsletter on new and emerging health care technologies in Canada

Scanning the horizonInforming decision makers about emerging medical technologies

Issue 2 January 2006

We would be delighted to have yourfeedback and suggestions for newtechnologies to review in future issues of the newsletter. Please send comments to: Catherine Allison, Editor. E-mail: [email protected]

Although this technology waslicensed by Health Canada in 2003, ithas not yet been used in clinicalpractice here.

8 New and emerging healthtechnology reports, a listing ofrecent publications from severalhealth technology assessmentagencies

Page 2: Scanning the horizon - CADTH.ca · A newsletter on new and emerging health care technologies in Canada Scanning the horizon Informing decision makers about emerging medical technologies

An emerging type of delivery

system may be a prescription for

the current shortage of

pharmacists in Canada.

Telepharmacy is an application oftelehealth. It allows pharmacy servicesto be provided at a remote site, while apharmacist supervises the work from acentral site, using telecommunicationand information technologies.

How telepharmacy works

A pharmacy technician at the remote sitesends a copy of the doctor's medicationorder and the patient's completemedication record to the pharmacist byfax or e-mail. Alternatively, thepharmacist can view the patient'srecords by signing into the hospital'scomputer system through a secureportal.

The pharmacist reviews the order anddiscusses any medication-relatedproblems with medical staff at theremote site. The pharmacy technicianthen fills the order. A second technicianchecks the final product; or if a reliablebroadband transmission is available, thepharmacist can verify the technician'swork with a videoconferencing camera.The high-resolution cameras can zoomin to see details of the actual dispensedmedication.

Pharmacist shortage

Rural communities in British Columbiaand Ontario have developedtelepharmacy systems to help cope witha Canada-wide shortage of pharmacists,estimated in 2001 to number more than2,000 positions.1

British Columbia

In June 2003, the East KootenayRegional Hospital in Cranbrook, BCinitiated the first Canadian

telepharmacy service when a hospital ina neighbouring town could not recruit apharmacist.2 The service has sinceexpanded to include supervision ofpharmacy technicians at 20-bedhospitals in nearby Fernie and Creston.Other British Columbia hospitals haveimplemented telepharmacy servicesbetween Williams Lake and 100 MileHouse; Quesnel and Terrace; and PrinceGeorge and Fort St. John. Telepharmacyalso allows for vacation coverage andsick relief, particularly for hospitals thatemploy only one pharmacist.

Ontario

Pharmacist Kevin McDonald begantelecommuting from his Ottawa homeoffice in April 2004 to provide remotepharmacy services to the hospital inMoose Factory.

In September 2005, Kurt Schroederbegan providing telepharmacy supportto the Timmins hospital from his homeoutside of Ottawa. His remote orderverification allows the on-sitepharmacists, already short-staffed, to domore direct patient care on the hospitalwards.

Evidence of effectiveness

Though this evidence gap was identifiedin 1999, assessments and systematicreviews of telepharmacy services are notyet available.3

2 Issue 2 January 2006

HEALTH TECHNOLOGY UPDATE

Virtual pharmacists provide long-distance care

Pharmacy technician, Betty Cheechoo, fills aprescription at the Weeneebayko GeneralHospital in Moose Factory, ON.

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Telepharmacy regulations

The College of Pharmacists of BritishColumbia is the only provincial licensingbody in Canada with telepharmacyguidelines4, although the ManitobaPharmaceutical Association is developingthem. The Ontario College of Pharmacistsdoes not have jurisdiction over hospitaloperations, including telepharmacy.

Cost

Set-up costs include basic computerequipment, software and avideoconference camera. Telepharmacyis funded in British Columbia under thepharmacy budget of the hospitalproviding the services. Hospitals innorthern Ontario are contracting theservices of pharmacists employed by acommunity pharmacy in Moose Factory.

References

1. Peartree Solutions Inc. A situational analysis of human resource issues in the pharmacy profession inCanada. Ottawa: Human Resources Development Canada; 2001. Available:http://www.pharmacists.ca/content/about_cpha/whats_happening/government_affairs/pdf/executive_summary.pdf.

2. Technology drives telehealth in Kootenay boundary and East Kootenay [news release]. Vancouver: IHCommunications; 2003 Nov 3. Available: http://www.interiorhealth.ca/NR/rdonlyres/9AD12211-732D-4EDA-A3BB-F7AD7E03B572/694/TechDrivesTelehealth.pdf.

3. Angaran DM. Am J Health Syst Pharm 1999;56(14):1405-26.

4. College of Pharmacists of British Columbia. Professional practice policy: Telepharmacy.Vancouver:2005. Available:http://www.bcpharmacists.org/resources/councilcommittees/pdf/telepharmacy.pdf.

Page 3: Scanning the horizon - CADTH.ca · A newsletter on new and emerging health care technologies in Canada Scanning the horizon Informing decision makers about emerging medical technologies

The Leksell Gamma Knife uses

multiple beams of radiation to

perform stereotactic

radiosurgery inside the skull

without making an incision.

With pinpoint accuracy that sparessurrounding tissue, the radiationdestroys lesions within the brain,including tumours, arteriovenousmalformations and other abnormalitiesthat cause functional disorders, such astrigeminal neuralgia.

How it works

Diagnostic imaging, such as computedtomography (CT) or magneticresonance imaging (MRI), is used tolocate the target area. The patientwears a head frame to keep the headimmobile during the treatment. TheGamma Knife delivers radiation thatcauses the tumour or lesion to stopgrowing or to shrink. Patientsexperience minimal pain during thetreatment and they usually go home on the same day.

Gamma Knife units in Canada

Although the Gamma Knife wasdeveloped several decades ago it isrelatively new to Canada.

Evidence of clinical effectiveness

Many assessments have examined theevidence for Gamma Knife use andother modes of stereotacticradiosurgery for various conditions.Still lacking are studies that compareoutcomes with Gamma Kniferadiosurgery to other types ofradiosurgery delivery. These includethe Novalis® shaped beamradiosurgery system and modifiedlinear accelerators (Linacs) or systemsbased on linear accelerators, such asthe CyberKnife® and XKnife™. Unlikethe Gamma Knife, which is used onlyfor intracranial conditions, some ofthese other systems can be used forradiosurgery elsewhere in the body.

Cost

The Gamma Knife costs about C$5million. An additional C$1 million to

Issue 2 January 2006 3

HEALTH TECHNOLOGY UPDATE

Gamma Knife® update

Patient in the Leksell Gamma Knife head frame.

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Gamma Knife Unit

Winnipeg Centre forGamma Knife Surgery

Quebec Gamma KnifeCentre

Joey and TobyTanenbaum Family

Gamma Knife Centre

Centre

Winnipeg Health Sciences Centre

Centre hospitalier universitaire de Sherbrooke (CHUS)

University Health Network,Toronto General Hospital

Date Opened

20031

20042

20053

References

1. Canada's first and only state-of-the-art GammaKnife unveiled at Winnipeg's Health SciencesCentre [news release]. Winnipeg (MB):Winnipeg Regional Health Authority; 2003.Available:http://www.wrha.mb.ca/howcare/mdesk/news001.php.

2. Raymond S. Le CHUS et la Faculté de médecinerayonnent grâce au Gamma Knife [news release].Sherbrooke (QC): Université de Sherbrooke;2004. Available:http://www.usherbrooke.ca/liaison_vol39/n05/a_knife.html.

3. Ontario's first Gamma Knife arrives at theToronto Western Hospital [news release]. Toronto:Toronto Western Hospital / University HealthNetwork; 2005 May 24. Available:http://www.uhn.ca/media/releases/2005/may/gamma_knife_release_may2605.pdf.

4. Toronto Western Hospital to receive Ontario's firstGamma Knife [news release]. Toronto: TorontoWestern Hospital / University HealthNetwork; 2004 Jun 10. Available:http://www.uhn.ca/media/releases/2004/june/twh-neuro-gamma-061004.pdf.

5.Ohinmaa A. Cost estimation of stereotacticradiosurgery: Application to Alberta. Edmonton(AB): Alberta Heritage Foundation for MedicalResearch (AHFMR); 2003. Available:http://www.ahfmr.ab.ca/hta/hta-publications/infopapers/ip14.pdf.

C$2 million is typically needed for set-up costs. Annual operating costs areestimated to be C$1.3 to C$1.5million.1,3,4

The Gamma Knife's cobalt-60 radiationsource must be replaced about everyfive years, at an estimated cost of C$1.1million (including disposal costs for theold source).5

Page 4: Scanning the horizon - CADTH.ca · A newsletter on new and emerging health care technologies in Canada Scanning the horizon Informing decision makers about emerging medical technologies

A new treatment uses a modified

sample of a patient's own blood

to stimulate the immune system

to fight chronic inflammation that

damages the heart.

Under development by Ontario-basedVasogen Inc., the immune modulationtherapy is called Celacade™.

How does it work?

Celacade therapy is performed once amonth during a 30-minute outpatientvisit, reports Glenn Neumann,Director of Investor Relations forVasogen Inc.

A nurse withdraws 10 mL of thepatient's blood and transfers thesample to the Celacade machinewhere it is exposed to heat, oxygenand ultraviolet light for three minutes.The modified blood is then injectedback into the patient.1

When the modified blood cells re-enter the body, a series of biologicresponses is triggered, most notablyan increase in the production ofchemical messengers (cytokines) thatdecrease inflammation.1 This responseis believed to slow or stop the chronicinflammatory process responsible fordamaging the heart.

Patient Group

Celacade treatment is intended forpatients with chronic heart failure.2

Heart failure occurs when the heartcannot pump enough blood to meetthe body's needs. It is often a result ofcoronary artery disease and/or highblood pressure. Treatment usuallyincludes medication and lifestylechanges such as diet adjustment andsmoking cessation.

Heart failure affects more than 400,000Canadians, with over 50,000 new casesannually.3 In 2002, more than 4,500Canadians died from heart failure.4

Regulatory approval

Celacade is not currently licensed byHealth Canada or the US Food andDrug Administration.

Evidence

A randomized, double-blind, placebo-controlled Phase II trial that enrolled75 patients with chronic heart failureon standard therapy found astatistically significant reduction in therisk of death and all-causehospitalizations in patients whounderwent treatment with Celacadefor six months compared with patientswho received placebo.1 There were 39serious adverse events reported,including one death, among 14patients receiving Celacade treatment;compared with 67 serious adverseevents, including seven deaths, in 24patients who received placebo. Noneof the events were considered to betreatment related.

Completion of a Phase III clinical trial(ACCLAIM), which includes 2,400patients, was expected by the end of2005.2

Cost

The cost of Celacade treatment isunknown.

Other indications

Celacade is being studied for thetreatment of patients with intermittentclaudication, a painful leg conditionthat is associated with peripheralartery disease. However, Vasogen Inc.prematurely halted its phase III trialfor this indication in August 2005 due

HEALTH TECHNOLOGY UPDATE

Combating inflammation associated with heart failure

The Celacade system treats the patient's blood in amachine that is slightly larger than a desktop computer.

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ogen

Inc.

References

1. Torre-Amione G, et al. Am J Cardiol2005;95(11A):30C-7C.

2. Vasogen receives CE mark for Celacade™ inEurope for the treatment of chronic heart failure.Mississauga (ON): Vasogen; 2004. Available:http://www.vasogen.com/sec/pr_1075729253.

3. Kostuk WJ. CMAJ 2001;165(8):1053-5.

4. Death, by cause: heart failure [table 102-0529].Ottawa: Statistics Canada; 2002.

5. Vasogen announces the early close out of theSIMPADICO Peripheral Arterial Disease trial[news release]. Vasogen Inc.; 2005 Aug 30.Available:http://www.vasogen.com/sec/pr_1125371515.

to a possible lack of effectiveness.5 Thefinal results of this trial have not beenreleased.

4 Issue 2 January 2006

Page 5: Scanning the horizon - CADTH.ca · A newsletter on new and emerging health care technologies in Canada Scanning the horizon Informing decision makers about emerging medical technologies

A digital foot thermometer used

in the home can help people

with diabetes check for "hot

spots" on the soles of their feet.

The portable device monitors foottemperature fluctuations, whichcommonly occur before ulcers breakthrough the skin.

How the TempTouch®

thermometer works

The TempTouch thermometer is usedto take foot temperatures once or twicedaily by touching the infrared sensortip to specific points on the bottom ofthe feet. The readings are recorded bythe patient in a daily logbook.

Issue 2 January 2006 5

HEALTH TECHNOLOGY UPDATE

Foot thermometer helps prevent diabetic ulcers

There is early warning that an ulcermay be developing if the temperatureof one foot is significantly greater thanthe other.1 Should this occur,individuals are advised to contact ahealth professional and take pressureoff the foot or reduce their activitylevels until the temperature differencefalls below 2.2oC.

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Inc.

Who might benefit

The number of Canadians with diabetesis expected to reach three million by theend of the decade.2 Foot ulcers developin up to 15% of adults who havediabetes. Peripheral neuropathy, presentin 60% of those with diabetes, confersthe greatest risk of foot ulceration;microvascular disease and suboptimalblood sugar control also contribute.About 12% of those who developdiabetic ulcers will eventually requireamputation, with almost half beingamputations of the leg.3

Regulatory Approval

San Antonio, Texas manufacturer, XilasMedical Inc., received US Food andDrug Administration marketingapproval for the TempTouch infraredfoot thermometer in March 2005.4 Thedevice is not licensed by HealthCanada.

Cost

TempTouch is sold by prescription inthe US for US$150.5

Evidence of efficacy

In two randomized, single-blind trials,patients at high risk of diabetescomplications, who used TempTouchfor six months, developed fewercomplications than those who did notmonitor foot temperature.1,6 One of the41 patients who used TempTouchdeveloped diabetic foot complicationscompared with nine from the 44patients in the standard care group.1

In the second study, 180 patients werefollowed for 15 months.6 Patients usingTempTouch developed significantlyfewer foot ulcers (8.5%) than those whohad standard care (29.3%) or those whoperformed a structured foot evaluationtwice daily in addition to receivingstandard therapy (30.4%).

References

1. Lavery LA, et al. Diabetes Care 2004;27(11):2642.Available : http://care.diabetesjournals.org.

2. The prevalence and costs of diabetes. Toronto:Canadian Diabetes Association; 2004.Available:http://www.diabetes.ca/Section_about/prevalence.asp.

3. Stillman RM. Diabetic ulcers E Medicine; 2005 Mar22. Available:http://www.emedicine.com/med/topic551.htm.

4. Xilas Medical, Inc. receives 510(k) clearance from FDAfor its TempTouch® home temperature monitoringdevice [news release]. San Antonio (TX): XilasMedical, Inc; 2005 Mar 30. Available:http://www.xilas.com/pressreleases/30march2005.pdf.

5. Xilas' TempTouch® home temperature monitoringdevice now available to diabetic foot consumers [newsrelease]. San Antonio (TX): Xilas Medical, Inc; 2005Jul 11. Available:http://www.xilas.com/pressreleases/11july2005.pdf.

6. Xilas Medical, Inc. - clinical trial findings andconclusions. San Antonio (TX): Xilas Medical, Inc;2005 Jul 11. Available:http://www.xilas.com/clinicaltrials.pdf.

7. Xilas Medical Inc. receives Phase II funding from theNational Institutes of Health for diabetes telemedicinegrant [news release]. San Antonio (TX): XilasMedical, Inc; 2005 Apr 4. Available:http://www.xilas.com/pressreleases/4april2005.pdf.

The TempTouch probe is curved to facilitate contact with the bottom of the feet

Future developments

Xilas Medical Inc. is undertakingclinical trials with TempTouch RM®, adevice that individuals stand on like abathroom scale.7 The device measuresand records foot temperatures and thepatient's weight before transmitting theinformation by the Internet to thedoctor's office.

Page 6: Scanning the horizon - CADTH.ca · A newsletter on new and emerging health care technologies in Canada Scanning the horizon Informing decision makers about emerging medical technologies

HEALTH TECHNOLOGY UPDATE

References

1. Mittmann N, et al. Economic evaluation of drug eluting stents [Technology report no 53]. Ottawa:Canadian Coordinating Office for Health Technology Assessment; 2005. Available:https://www.ccohta.ca/publications/pdf/272_drug_eluting_stents_tr_e.pdf.

2. 2005 Canadian Cardiovascular Society Consensus Conference: peripheral arterial disease. Ottawa:Canadian Cardiovascular Society; 2005. Available:http://www.ccs.ca/download/draft_full_document_3_.pdf.

3. Weinberger J, et al. Am J Ther 2005;12(2):186-91.

4. Duda SH, et al. Circulation 2002;106(12):1505-9.

5. Duda SH, et al. J Vasc Interv Radiol 2005;16(3):331-8.

6. Cook to begin first international trial of a paclitaxel-eluting stent for peripheral artery disease [newsrelease]. Angioplasty.org; 2005 May 3. Available: http://www.ptca.org/pr_cook/20050504.html.

Drug-eluting stents have

significantly decreased the

complication rate of coronary

artery disease treatment.1 They

have also added significantly to

health care costs.1 Now stents

with a drug coating are being

tested in patients with peripheral

artery disease (PAD).

What is peripheral arterydisease?

PAD is similar to coronary arterydisease in that fatty deposits build upin the arteries and block blood flow tothe legs and feet. Reduced blood flowin the femoropopliteal artery, the majorartery in the thigh, can cause leg painwith exercise (intermittentclaudication) and can lead to skinulcers, gangrene and amputation.

An estimated 4% of Canadians olderthan 40 have PAD; this numberincreases to 20% in people older than75.2

Treatment

PAD is treated with regular exerciseand medication to control risk factors.2

However, at least 25% of patientsrequire angioplasty treatment, where aballoon-tipped catheter is insertedthrough a small incision in the groin toenlarge the narrowed artery.3

Unfortunately, a frequent consequenceof angioplasty is restenosis (re-narrowing) of the artery that has beenopened.

Stents

Angioplasty can be combined with astent, which is a wire mesh "scaffold"that remains in the artery to keep itpropped open.

Drug-eluting stents for peripheral artery disease

Stent use for obstructivefemoropopliteal artery disease iscontroversial. Several studies2 haveshown that long-term results with stentimplantation are no better thanangioplasty alone. Stents are currentlyrecommended only when angioplastyresults are suboptimal.2

Recently, two new drug-coated stentshave been developed. These releasesmall amounts of medication intendedto help prevent tissue scarring, whichcan cause restenosis at the stent site.Not yet approved in any country, earlydata on their clinical use are emerging.

Sirolimus-coated stents for PAD

Cordis Corporation has reported theresults of two small trials with theirsirolimus-coated S.M.A.R.T.® Nitinol

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The self-expanding, flexible, nitinol (nickel-titanium) Zilver®PTX™ stent is the size of a crayon.

Self-expanding Stent. In the first trialenrolling 36 patients, the onlystatistically significant difference at sixmonths was that patients who receivedsirolimus-coated stents had a largerfemoral artery diameter comparedwith those who received uncoatedstents. The restenosis rate at the stentsite was lower in the sirolimus-elutingstent group; however it was notstatistically significant, possibly due tothe small sample size.4

A second trial with 57 patients foundno statistically significant differencesin six-month artery diameter orrestenosis rates between patients withsirolimus-coated stents and those withuncoated stents.5

Paclitaxel-coated stents for PAD

The Zilver PTX, a paclitaxel-coatedstent manufactured by CookIncorporated, is now being evaluatedin an international multi-centre clinicaltrial.6

Cost

The costs of the Zilver PTX and thesirolimus-eluting S.M.A.R.T. nitinolstents are unknown. It is alsounknown if the cost of using drug-coated stents would offset additionalcosts of performing repeat proceduresto treat restenosis.

6 Issue 2 January 2006

Page 7: Scanning the horizon - CADTH.ca · A newsletter on new and emerging health care technologies in Canada Scanning the horizon Informing decision makers about emerging medical technologies

Issue 2 January 2006 7

A minimally invasive technology

for clearing totally blocked

coronary arteries may allow

more patients to be treated with

coronary angioplasty and

stenting procedures rather than

with open heart surgery.

The Safe-Cross® Radiofrequency TotalOcclusion Crossing System combines a visual display and guidancetechnology with radiofrequencyenergy delivered through a catheterguide wire to burn through blockagesin coronary arteries.

The "optical coherence reflectometry"guidance system allows physicians tomonitor the proximity of the wall ofthe artery to avoid puncturing it; theradiofrequency energy automaticallyshuts off if the catheter comes too closeto the artery wall. Once the guide wirehas passed through the total occlusion,it can be treated with conventionalangioplasty and stent devices.

Radiofrequency ablation for totally occludedcoronary arteries

Who might benefit

Each year about 40,000 Canadiansundergo balloon catheter angioplastyto clear blockages in their coronaryarteries.1

However, for patients with chronictotal occlusion (CTO), the artery iscompletely blocked, making it difficultfor the guide wire to pass through.About one-third of patients withsuspected or known coronary arterydisease have CTO.2 Many patients withCTO are not considered suitablecandidates for angioplasty, and may beoffered drug treatment and/or coronaryartery bypass surgery instead.

Current regulatory status

Health Canada licensed the Safe-CrossRadiofrequency Total OcclusionCrossing System (IntraLuminalTherapeutics Inc., Carlsbad, CA) inAugust 2003. The Safe-Cross systemhas not yet been used in Canada, buthas been available in Europe for severalyears and in the US since early 2004.3

Evidence

The Safe-Cross system was evaluatedin a prospective registry study of 116patients with CTO of coronary arteries.All patients had previously undergoneunsuccessful attempts at angioplastywith conventional guide wires. TheSafe-Cross system achieved successfulcrossing of the CTO in 63 patients(54.3%).3 Eight patients (6.9%)experienced major adverse events(myocardial infarction or perforation ofthe artery). Perforations occurred inthree patients (2.6%); however theperforation was linked to use of theSafe-Cross device in only one patient(0.9%). No deaths occurred and noemergency bypass surgeries wereneeded.

Cost

The Safe-Cross console and generatorcost US$45,000. Lease or rental optionsare available. The disposable itemsused for each procedure cost US$1,600.Further evidence is needed todetermine if device costs are offset bycost savings in shorter hospital stays,improved patient outcomes and qualityof life.

HEALTH TECHNOLOGY UPDATE

References

1. Centre for Chronic Disease Prevention andControl, Health Canada, et al. The growing burden ofheart disease and stroke in Canada. Ottawa: Heart andStroke Foundation of Canada; 2003. Available:http://www.cvdinfobase.ca/cvdbook/CVD_En03.pdf .

2. Kahn JK. Am Heart J 1993;126(3 Pt 1):561-4.

3. Baim DS, et al. Am J Cardiol 2004;94(7):853-8.

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Waveform communication guides the use of the Safe-Cross® system in an arterial occlusion.

Page 8: Scanning the horizon - CADTH.ca · A newsletter on new and emerging health care technologies in Canada Scanning the horizon Informing decision makers about emerging medical technologies

HEALTH TECHNOLOGY UPDATE

8 Issue 2 January 2006

As part of our horizon scanning wecheck the web sites of other HTAagencies for recent assessments thatmay be of interest to Canadian healthcare decision makers. Unless otherwisestated, these publications are availablewithout cost at the web sites shownbelow.

Agence d'évaluation destechnologies et des modesd'intervention en santé (AETMIS)

Surgical treatment of morbid obesity:an updateIncluded is the latest evidence ondifferent types of bariatric surgeryused for the treatment of morbidobesity, with recommendations for themanagement of these surgicalprograms in Quebec.Available:http://www.aetmis.gouv.qc.ca/site/index.php?id=250,405,0,0,1,0

Alberta Heritage Foundation forMedical Research (AHFMR)

Image-guided vacuum-assisted breastbiopsy for suspicious, non-palpablebreast lesionsAn assessment of a less invasiveapproach to biopsy in the diagnosis ofbreast cancer.Available:http://www.ahfmr.ab.ca/download.php/0d7e234a84f703ed426fa9f37ecf236c

Canadian Coordinating Officefor Health TechnologyAssessment (CCOHTA)

Cerebral protection devices for useduring carotid artery stentingThese devices offer a new approach toreducing the risk of stroke or death inpatients undergoing carotid arteryangioplasty with stenting. Increaseddemand for this procedure, as analternative to surgical carotidendarterectomy, may have a significantimpact on health care costs and servicedelivery. Available:https://www.ccohta.ca/publications/pdf/360_cerebral_protection_devices_cetap_e.pdf

UK National Horizon ScanningCentre (NHSC)

FibroTest-ActiTest™ for diagnosis andmonitoring of fibrosis in chronic liverconditionsThe FibroTest-ActiTest is a non-invasive alternative to liver biopsy forpatients with chronic hepatitis andother liver diseases.Available:http://pcpoh.bham.ac.uk/publichealth/horizon/PDF_files/2005reports/FibroTest_ActiTest.pdf

UK National Institute for Healthand Clinical Excellence (NICE)

Cryotherapy as a primary treatment forprostate cancer Current evidence supports the safetyand effectiveness of cryotherapy as aprimary treatment for prostate cancer,though further information on qualityof life and long-term survival isneeded.Available:http://www.nice.org.uk/pdf/ip/IPG145guidance.pdf

Health Technology Update is publishedby the Canadian Coordinating Officefor Health Technology Assessment(CCOHTA)

600-865 Carling AveOttawa, ON Canada K1S 5S8Telephone: (613) 226-2553Fax: (613) 226-5392Web site: www.ccohta.ca

Editor/Writer: Catherine Allison

Contributing Writers: Leigh-Ann Topfer, Rhonda Boudreau,David Hailey

Information Specialists:Andra Morrison, Kaitryn Campbell

Copy Editor: Jane Mosgrove

Production Coordinator:Carol O'Malley

Web Designer:Martha Hodgson-Oram

This newsletter is available free of charge, inboth English and French. Readers maysubscribe to receive e-mail notification ofnew issues using the subscription link on theCCOHTA web site or the following URL:https://www.ccohta.ca/hta/health_technology_update/subscribe.cfm [email protected]

Reproduction of this document for non-commercial purposes is permitted providedappropriate credit is given to CCOHTA.

Production of this report is made possible byfinancial contributions from Health Canada andthe governments of Alberta, British Columbia,Manitoba, New Brunswick, Newfoundland andLabrador, Northwest Territories, Nova Scotia,Nunavut, Ontario, Prince Edward Island,Québec, Saskatchewan, and Yukon. The CanadianCoordinating Office for Health TechnologyAssessment takes sole responsibility for the finalform and content of this report. The viewsexpressed herein do not necessarily represent theviews of Health Canada or any provincial orterritorial government.

ISSN: 1715-5541 (print)ISSN: 1715-555X (online)

PRODUCTION NOTES

New and emerging health technology reportsRecent publications from CCOHTA and other HTA agencies

The information included in thisnewsletter is based on a limited literaturereview and should not be construed as arecommendation for or against the use of aparticular health technology. Readers arealso cautioned that a lack of good qualityevidence to support effectiveness does notnecessarily mean a lack of effectiveness,particularly in the case of new andemerging technologies.