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CARDIAC CATH • EP • CRM • ECHO • CT/MRI

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Issue 34 • Jan/Feb 2012

Royal United Hospital, Bath + Great Western Hospital, Swindon Site Visits

HYBRID DESIGN + INNOVATION + DYNAMIC : INTEGRATING WEB & PRINT


The leading cardiovascular Course

15th-18th May, 2012 - Paris

New! The EuroPCR How should I treat? programme is out .42 National Societies and Working Groups .23 sessions .One of the most popular PCR session format, well-known to EuroIntervention readers .An introduction by Jean Fajadet, President of the EAPCI

Don't wait to get the programme, go now to www.europcr.com


Jan / Feb 2012

Contents Long-Term Clinical Benefits of BioMatrix Flex™ Confirmed in The Lancet: Latest Product News

Siemens Healthcare supports the study of real life clinical cases with syngo.via

Proof of Concept for Biodegradable Polymer

Round Up

The British Institute of Radiology (BIR), with technical support from Siemens Healthcare, has recently run a Cardiac CT level II1 course for visiting radiology professionals from Iraq. The four day course delivered training on the skills required to produce and interpret clinical cases and included the study of 150 cases using the Siemens’ syngo®. via imaging workstation application. Further Cardiac CT courses run by the BIR and supported by Siemens will be open to interested parties in February, July and September 2012.

“Don’t Cut Your Tips” New program recycles whole EP catheters Catheter recycling created a buzz at the Heart Rhythm Congress meeting in Birmingham last October. EPreward, a U.S. company created and managed by an EP nurse, purchases whole diagnostic EP and ultrasound catheters thereby providing Cardiology Departments with additional funds for continuing education and other department needs.

New data published in The Lancet shows that BioMatrix Flex™, Biosensors’ Biolimus A9™-eluting stent system with a biodegradable polymer coating, significantly reduces the risk of very late stent thrombosis (VLST) compared to that of a drug-eluting stent (DES) system with a durable polymer coating after four years. This is positively associated with a reduced risk of cardiac events, therefore demonstrating for the first time ‘proof of concept’ that a DES with biodegradable polymer improves long-term clinical outcomes compared to a DES with durable polymer.

In the past, EP staff would cut the tips of EP catheters as part of a platinum recovery program. Now these departments are earning over four times more by selling their whole catheters to EPreward. “Brilliant” was used more than once to describe this new program. To verify this difference in earnings, an prominent NHS hospital conducted a side by side test using an identical batch of catheters. Payment from the London Refinery, EP Recyclers/Eco-Wires Recycling and EPreward’s platinum tip and whole catheter “Buy Back” program was determined for the same 345 catheters with the results shown below.

“This study shows that the problem of very late stent thrombosis, which was prevalent with first-generation durable-polymer drugeluting stents, is markedly reduced by a stent using a biodegradable polymer”, commented Principal Investigator Professor Stephan Windecker, University Hospital, Bern, Switzerland. “This translates into a late benefit in terms of cardiac death or myocardial infarction.” For more information visit www.biosensors.com.

Russell Lodge, CT Business Manager at Siemens Healthcare states, “The hands-on sessions involving real-to-life cardiac CT cases help delegates to analyse and interpret major pathology groups including normal anatomy, anatomical variants, normal CT angiography, atherosclerotic CAD as well as post PCI and post surgery assessment.” The Cardiac CT courses are suitable for delegates that are performing cardiac imaging on any suitable CT platform and prior experience on Siemens syngo.via or CT scanners are not expected.

Dan Gibbons, Applications Specialist CT at Siemens Healthcare (left) and Dr. Ed Nicol, Consultant Cardiologist at Royal Brompton and Harefield NHS Foundation Trust and BIR Cardiac CT Course Director (right) discuss real life cardiac CT case examples with visiting radiology delegates from medical institutions in Iraq.

For further information on the planned courses for 2012, please visit www.bir.org.uk.

Cardiology Ad-Final_Template 07/10/2011 14:31 Page 1

Hospital Earnings for an Identical Group of 345 EP Catheters The London Refinery Platinum Recovery

EP Recyclers/Eco-Wires Recycling Platinum Recovery

EPreward Platinum Recovery

EPreward Whole Catheter Buy Back

£ 651.79

£ 818.06

£ 1,445.90

£ 3,191.00

Wednesday 18th January 2012

Specialist Cardiac Staff Required Regent’s Park Heart Clinics Ltd. are actively recruiting for specialist cardiac staff. Employment opportunities are available within both an invasive and non-invasive cardiac setting. We are inviting applications for the following positions:

You can reach EPreward at contact@epreward.com or visit their website at www.epreward.com. EPreward documents every catheter and catheter tip, provides all collection materials and pays for shipping. Time to settlement is one week from the date of receipt. The EPreward website also contains over 75 FREE educational programs, a Training and Review section and much more. Don’t settle for less, receive the earnings you deserve with EPreward.

At one year, all-cause mortality was 30.7% for transcatheter aortic valve implantation (TAVI) and 50.7% for standard therapy. At two years, TAVI patient mortality remained superior, with the curves diverging further to 43.3% versus 67.6%, respectively.

eter device enabling aortic valve replacement without the need open-heart surgery.

Why, When, Where and How?

Cardiac Physiologist (Non-Invasive) - Cambridge

Friday 27th April 2012

This position is within a private patient facility operated by Regent’s Park called the Cambridge Heart Clinic, and requires the applicant to have the necessary skills to independently perform echocardiography, exercise testing and ambulatory monitoring. For more information visit: www.cambridgeheartclinic.co.uk

A comprehensive one day symposium for all trainees considering a period of research towards attaining a PhD or MD.

Royal College of Physicians, London

For more details and the full programme, visit the BCS website.

To find out more please contact Bryn Webber, Cardiac Services Director: bryn.webber@rphc.co.uk

Online registration is now open on www.bcs.com

Hear about the latest changes, exchange best practice, listen to innovative case studies and network with your peers:

Take away ideas from the trailblazers and adapt them to your own trust:

• Eradicate bottlenecks: implement cardiac physiologist led rapid access clinics and improve access, and savings through one-stop • Invest to save: share QIPP strategies and build a business case to invest in remote monitoring • Transform your workforce: make Modernising Scientific Careers work, improve productivity through Assistant Practitioners and implementing a 24/7 primary angioplasty service • Deliver services in the community: share commissioning plans and reconfigure to achieve satellite services

Benefit from this practical case study driven day

Please visit our website for more details on our background and capabilities: www.rphc.co.uk

Right: Edwards SAPIEN XT valve

Imaging

Stem cells may aid heart repair The Daily Telegraph reported that it may be possible for patients to use their own stem cells to repair the damage caused by heart attacks. The newspaper said that heart repair with stem cells could be the “biggest breakthrough in a generation”.

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Beh nd he Head nes

The news is based on a small safety trial that tested whether people with heart failure could have stem cells extracted from their heart, grown in a lab and safely injected back into the heart. The study, which is still in progress, found that the treatment did not lead to any negative effects in the year after treatment. Participants also saw improvements in heart function, scarring and quality of life compared with before treatment. A group of volunteers with heart failure who were not given the treatment showed no improvements in the symptoms of their heart failure. This trial has shown another potential application for stem cells, which are at the forefront of medical research. However, the study was designed to look at safety rather than effectiveness, and was, accordingly, short and small. Given the limited nature of the trial, larger, longer trials will now be required to see whether these initially promising results can be replicated and whether the technique will prove safe and effective in the long-term.

However, CMR will not be suitable for all patients, including some with medical implants and those who could experience claustrophobia inside the scanner. Further research will also be needed to demonstrate that improved diagnosis through techniques such as CMR actually improves patient outcomes. That said, these results do suggest the technique has merit.

When 2 places booked

The Facts

The Facts

This story is based on a large, well-designed study comparing a new technique called cardiovascular magnetic resonance (CMR) imaging against the commonly used alternative test, single-photon emission computed tomography (SPECT). The researchers tested the scan’s ability to diagnose significant coronary heart disease, also looking at how they compared against standard angiography, where dye is introduced into the blood vessels to highlight any blockage or narrowing. The study found that CMR performed as well or better than SPECT on a number of key diagnostic measures. Together with the fact that CMR does not expose patients to ionising radiation, the researchers say the results show that CMR should be more widely adopted.

NHS SPeCIAl PRICe

ONLY £299 each

www.cardiologyhd.com Jan/Feb 2012 7

Behind The Headlines

Study rates heart scan techniques

• The Royal Berkshire NHS Foundation Trust • NHS Improvement

Tel: 01732 89 77 88 Fax: 01732 44 80 47 bookings@sbk-healthcare.co.uk | www.sbk-healthcare.com

The following articles are courtesy of NHS Choices

“Magnetic resonance imaging (MRI) scans should be used to assess patients with suspected heart disease, rather than standard checks,” reports BBC News today.

• City Hospitals Sunderland NHS Foundation Trust • The Newcastle upon Tyne Hospitals NHS Foundation Trust • South Tees Hospitals NHS Foundation Trust

BOOK YOUR PLACE NOW Run in association with the BCIS Research & Development Committee.

We look forward to hearing from you.

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Improve efficiency, share workforce solutions and deliver community services

This position is within a long term 2-day/week service (Tuesdays and Wednesdays) providing Diagnostic Coronary Angiography and Permanent Pacing.

The trial studied 358 patients with severe, symptomatic aortic stenosis deemed inoperable for open-heart surgery. Patients were evenly randomized to receive either the SAPIEN valve or standard therapy. On November 2, the Edwards SAPIEN valve also became the first U.S. FDA approved transcath-

SAPIEN patients spent significantly less time spent in hospital, with median days alive outside hospital of 699 compared with just 355 for standard therapy.

Latest Product News

Optimising Cardiac Physiology Services RESEARCH IN CARDIOLOGY

Radiographer (Cath Lab) - Scarborough

TAVI’s

Edwards Announce 2-Year PARTNER Trial Findings Edwards Lifesciences has announced two-year results of The PARTNER Trial Cohort B, a clinical study of inoperable patients with severe aortic stenosis treated with the Edwards SAPIEN transcatheter heart valve. These data demonstrated a widening survival benefit for SAPIEN patients at two years.

Reinvigorate your practices and relieve your pressures

Maple House, Birmingham

The study was funded by The University of Louisville Research Foundation and the US National Institutes of Health. It was carried out by the University of Louisville with lab work conducted by Brigham & Women’s Hospital, a teaching hospital affiliated with Harvard Medical School. It was published in the peer-reviewed medical journal The Lancet.

The study was carried out by researchers from the University of Leeds and was funded by the British Heart Foundation. The study was published in the peer-reviewed journal The Lancet.

The Daily Mail and The Daily Telegraph covered this study, with both highlighting that it was preliminary research that involved a small number of patients only.

Confusion over salt research “Salt is good for us after all,” according to the Daily Express. The newspaper said that a “controversial new study suggests that salt in the diet can lessen our chances of suffering heart disease and strokes”. The Express story itself should be taken with a large pinch of salt, as the study doesn’t suggest that eating high levels of salt is good for us. Instead, the research found that in white people with normal blood pressure, a low-salt diet only slightly reduced blood pressure but led to small increases in substances such as cholesterol.

The study itself was designed to pool and analyse the results of previous studies to determine how low-salt and high-salt diets affected blood pressure and a range of substances in the blood. Crucially though, many of the studies included in the review lasted only a few weeks and none were designed to look at the effect of salt reduction on longer-term health outcomes such as heart disease and stroke. Salt reduction is often intended to be a long-term measure, and therefore results looking at the practice over longer periods would be preferable. The Daily Express headline, “Salt is good for us after all” is therefore misleading. Both the Express and The Daily Telegraph included comments from external experts in their reports, some of which were critical of the study.

8 Jan/Feb 2012 www.cardiologyhd.com

GE Healthcare

For difficult-to-image patients, a simple-to-use solution The challenge of technically difficult echocardiography studies

Optison can improve diagnostic accuracy and clinical confidence

It has been estimated that 10%-15% of routine echocardiograms have incomplete endocardial resolution, making these studies difficult to interpret.1 The proportion may be even higher during stress echocardiography, with suboptimal images in up to one third of patients.2

Optison was highly effective, even in patients with chronic lung disease or dilated cardiomyopathy.4 Improvement in EBD by one or more segments4 All patients

Microbubble contrast agents can expand the diagnostic utility of echocardiography in such technically difficult studies.1

p<0.001

94%

93%

80 % patients

Patients with chronic lung disease or cardiomyopathy

p<0.001

100

High-resolution image of endocardial border delineation (EBD)

77%

74%

60 40 20 0

Unenhanced

Contrast-enhanced

Images courtesy of Rush University Medical Center, Chicago

65/69

54/70

Albunex* 0.22 ml/kg

Optison is simple to administer Easy resuspension allows quick access to contrast in the lab or on the go.5 No vial mixer is required – instead, simply invert the vial or gently rock-and-roll between your palms to resuspend.5

Impact of contrast on patient management1 2.2 8.2

142/193

Full (100%) left ventricle opacification was achieved in 87% of all patients and also 87% of the impaired function subgroup with Optison 3.0 ml.4 Conversion of non-diagnostic to diagnostic echocardiograms occurred in 74% of all patients with Optison 3.0 ml.4

Improving visualisation improves patient management By improving visualisation, contrast enhancement can reduce downstream utilisation of alternative testing resources. 3

25.2

177/190

Optison 3.0 ml (optimal dose as per study) *Albunex is no longer available in the EU Adapted from Cohen 19984

64.4

PRESCRIBING INFORMATION OPTISON™ 0.19 mg/ml dispersion for injection (Human albumin microspheres containing perflutren) Please refer to full Summary of Product Characteristics before prescribing. PRESENTATION Dispersion for injection supplied as 1 vial of 3 ml and 5 vials of 3 ml. OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in human albumin solution, 1%. CONCENTRATION Perflutren-containing microspheres, 5-8 x 108/ml with a mean diameter range of 2.5-4.5 μm. The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg. INDICATIONS This medicinal product is for diagnostic use only. OPTISON is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular endocardial border delineation with resulting improvement in wall motion visualisation. OPTISON should only be used in patients where the study without contrast enhancement is inconclusive. DOSAGE AND METHOD OF ADMINISTRATION OPTISON should only be administered by physicians experienced in the field of diagnostic ultrasound imaging. Before administering OPTISON, please see Instructions for use. The product is intended for left ventricular opacification after intravenous administration. Ultrasound imaging must be performed during injection of OPTISON as optimal contrast effect is obtained immediately after administration. Dosage: The recommended dose is 0.5-3.0 ml per patient. A dose of 3.0 ml is usually sufficient, but some patients may need higher doses. The total dose should not exceed 8.7 ml per patient. The duration of the useful imaging time is 2.5-4.5 minutes for a dose of 0.5-3.0 ml. OPTISON could be repeatedly administered, however, clinical experience is limited. Safety and efficacy of OPTISON in children and adolescents below 18 years has not been established; no recommendation on a posology can be made. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Pulmonary hypertension with a systolic pulmonary artery pressure > 90 mm Hg. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Hypersensitivity has been reported. Care should therefore be exercised. A course of action should be planned in advance with necessary drugs and equipment available for immediate treatment, in case a serious reaction should occur. The experience of OPTISON in severely ill patients is limited. There is limited clinical experience with OPTISON in patients with certain severe states of cardiac, pulmonary, renal and hepatic disease. Such clinical states include adult respiratory distress syndrome, the use of artificial respiration with positive end-expiratory pressure, severe heart failure (NYHA IV), endocarditis, acute myocardial infarction with on-going angina or unstable angina, hearts with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation system and/or recurrent thromboembolism, renal or hepatic end-stage disease. OPTISON should be used in these categories of patients only after careful consideration, and monitored closely during and after administration. Other routes of administration not specified in section “Dosage and method of administration” above (e.g. intracoronary injection) are not recommended. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes. It is strongly recommended that every time that OPTISON is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product. OPTISON contrast echocardiography should be accompanied by ECG monitoring. In animal studies, the application of echo-contrast agents revealed biological side effects (e.g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam. Although these biological side effects have not been reported in humans, the use of a low mechanical index and end-diastolic triggering is recommended. Efficacy and safety in patients below 18 years has not been studied. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. Use during anaesthesia with halothane and oxygen has not been studied. PREGNANCY AND LACTATION The safety of OPTISON for use during human pregnancy has not been established. In pregnant rabbits exposed to daily doses of 2.5 ml/kg (approximately 15 x the maximum recommended clinical dose) during organogenesis, maternal toxicity and embryo-foetal toxicity including a slight to extreme dilation of ventricles in the brain of developing rabbit embryos was observed. The clinical relevance of this finding is unknown. Therefore, OPTISON should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the physician. It is not known whether OPTISON is excreted in human milk. Therefore, caution should be exercised when OPTISON is administered to breast-feeding women. EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES No studies on the effects on the ability to drive and use machines have been performed. UNDESIRABLE EFFECTS Adverse reactions to OPTISON are rare and usually of a non-serious non-serio nature. In general, the administration of human albumin has been associated with transient altered taste, nausea, flushing, rash, headache, vomiting, chills and fever. Anaphylactic reactions have been associated with the administration of human albumin products. The reported adverse events following the use of OPTISON in Phase III human clinical studies have been mild to moderate with

Optison

subsequent full recovery. In clinical trials with OPTISON, undesirable effects were reported as adverse events with the following frequencies: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1,000 to <1/100; Rare ≥1/10,000 to <1/1,000; Very rare <1/10,000; not known (cannot be estimated from the available data). Undesirable effects: Common: Dysgeusia (altered taste), headache, flushing, nausea, warm sensation. Uncommon: Eosinophilia, dyspnoea, chest pain. Rare: Dizziness, paraesthesia, tinnitus, ventricular tachycardia. Not Known: Visual disturbances, allergic type symptoms (e.g. anaphylactoid reaction or -shock, facial oedema, urticaria). OVERDOSE No case of overdose has been reported. In the phase I trial, healthy volunteers have received up to 44.0 ml of OPTISON and experienced no significant adverse effects. INSTRUCTIONS FOR USE AND HANDLING Like all parenteral products, the vials of OPTISON should be inspected visually for integrity of the container. Vials are intended for single use only. Homogenous white suspension after resuspension. Once the rubber stopper has been penetrated, the contents should be used within 30 minutes and any unused product discarded. OPTISON in the nonresuspended form has a white layer of microspheres on top of the liquid phase that requires resuspension before use. The following instructions should be followed: • Cold solutions taken directly from the refrigerator should not be injected. • Allow the vial to reach room temperature and inspect the liquid phase for particulate matter or precipitates before resuspension. • Insert a 20 G plastic cannula in a large antecubital vein, preferably of the right arm. Attach a three-way stopcock to the cannula. • The OPTISON vial must be inverted and gently rotated for approximately three minutes to completely resuspend the microspheres. • Complete resuspension is indicated by a uniformly opaque white suspension and absence of any material on stopper and vial surfaces. • OPTISON should be withdrawn with care into a syringe within 1 minute after resuspension. • Any pressure instability within the vial should be avoided since it may cause disruption of microspheres and loss of contrast effect. Thus, vent the vial with a sterile spike or with a sterile 18 G needle before withdrawing the suspension into the injection syringe. Do not inject air into the vial as this will damage the product. • Use the suspension within 30 minutes after withdrawal. • OPTISON will segregate in an undisturbed syringe and must be resuspended before use. • Resuspend the microspheres in the syringe immediately before injection by holding the syringe horizontally between the palms of the hands and rolling it quickly back and forth for no less than 10 seconds. • Inject the suspension through the plastic cannula, no smaller than 20 G at a maximum injection rate of 1.0 ml/s. Warning: Never use any other type of route but the open flow connection. If injected otherwise OPTISON bubbles will be destroyed. • Immediately before injection a careful visual inspection of the syringe is mandatory in order to ensure complete suspension of the microspheres. • Immediately after injection of OPTISON, 10 ml of sodium chloride 9mg/ml (0.9%) solution for injection or glucose 50mg/ml (5%) solution for injection should be injected at a rate of 1 ml/s. Alternately, the flushing may be performed by infusion. The infusion set should then be attached to the three-way stopcock and intravenous infusion started at a “to keep open” (TKO) rate. Immediately after OPTISON injection the intravenous infusion should be wide open until contrast begins to fade from the left ventricle. The infusion should then be returned to a TKO rate. PHARMACEUTICAL PRECAUTIONS OPTISON must not be mixed with other medicinal products. A separate syringe should be used. OPTISON should be stored upright between 2ºC and 8ºC. Storage at room temperature (up to 25ºC) for 1 day is acceptable. Do not freeze. The shelf life of the product in the outer packaging is 2 years and of finished product after rubber stopper perforation: 30 minutes. MARKETING AUTHORISATION HOLDER GE Healthcare AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, N-0401 OSLO, Norway. CLASSIFICATION FOR SUPPLY Subject to medical prescription. MARKETING AUTHORISATION NUMBERS 1 x 3 ml: EU/1/98/065/001. 5 x 3 ml: EU/1/98/065/002. PRICE 5x3 ml: £286.30. Revision of text December 2010.

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By GE Hea hca e

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to GE Healthcare.

Roya Un ted Hosp ta Bath S te V s t

GE Healthcare Limited, Amersham Place, Little Chalfont, Buckinghamshire, England HP7 9NA www.gehealthcare.com

© 2011 General Electric Company – All rights reserved. GE and GE Monogram are trademarks of General Electric Company. GE Healthcare, a division of General Electric Company. Optison is a trademark of GE Healthcare Limited. References: 1. Kurt MG et al. J Am Coll Cardiol 2009; 9: 802-10. 2. Senior R et al. Eur J Echocardiogr 2009; 10: 194-212. 3. Dwivedi G et al. Eur J Echocardiogr 2009; 10: 933-40. 4. Cohen JL et al. J Am Coll Cardiol 1998; 32: 746-52. 5. Optison Summary of Product Characteristics. 6. Data on file, GE Healthcare.

Optison is stable at room temperature for up to 24 hours.5 0

20

40

60

80

100

% patients n=632 consecutive patients with technically difficult studies Procedure avoided only Medication change only Both medication and procedural change Unchanged Adapted from Figure 6, Kurt 20091

It can be repeatedly resuspended throughout the day and returned to proper storage if unused. Optison can be safely placed back in the refrigerator a maximum of five times before the expiry date.6 Customer service contact details

To order Optison or to find out more please use the following details:

Recommended by the European Association of Echochardiography

The use of ultrasound contrast agents is recommended by the European Association of Echocardiography when two or more contiguous segments are not well visualised on non-contrast images.2

Freephone: 0800 55 88 22 Freefax:

0800 66 99 33

Email:

ukcsorders@ge.com

GE Healthcare Limited Amersham Place, Little Chalfont Buckinghamshire, England HP7 9NA www.gehealthcare.com

05-2011 JB4528/LoremIpsum UK & INT’L ENG

10 Jan/Feb 2012 www.cardiologyhd.com

Journa Traw

Journals Dr John Paisey Journal Reviewer

Dr Dan McKenzie Journal Reviewer

Consultant Cardiologist, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Follow me @johnpaisey for the latest reviews

Consultant Cardiologist, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust

Peter R Kowey and others Circulation. 2011;124:2649-2660. Does adding clopidogrel to aspirin in patients unable to take warfarin for stroke prevention in AF make any difference? Not really. Stuart Connolly and others Ann Intern Med. (2011) 155: 9; 579-586.

Or do they? Long term (22 years) follow up data from the SHEP (Systolic Hypertension in the Elderly Program) study has shown that chlorthalidone +/- atenolol treatment significantly improves mortality, gaining about one day of extra life per month of taking the treatment.

the authors surmise that following an appropriate therapy private drivers should be banned for 2-4 months, but that no interruption in driving is required after elective implant or revision, or after an inappropriate shock which is programmed around. Professional driving however would be prohibited for life. This certainly contrasts markedly with UK regulations where certain professional drivers are allowed to continue, but other low risk circumstances attract bans of between one and six months. Joep Thijsson and others European Heart Journal. 2011; 32, 2678–2687. We have discussed before the difficulties in translating the obvious potential of transthoracic impedance monitoring in implantable devices into a useful heart failure monitoring tool. The DOT-HF investigated whether an audible and physician alert alarms could alter the risks of heart failure events. The trial struggled with enrolment, but a post hoc analysis after 335 patients were included and followed up revealed there was unlikely to be any demonstrable benefit of the monitoring regime. Clearly, further work is required for us to be able to understand how to use these tools. Dirk J. van Veldhuisen and others Circulation. 2011;124:1719-1726.

Stroke Risk and Anticoagulation Implantable Devices CRT (probably) works by making the latest contracting part of the left ventricle (LV) contract closer to simultaneously with the rest of the ventricles. Measuring the delay from QRS onset to the sensed LV electrogram should identify both the potential benefit of retiming (more delay, more dysynchrony) and selection of a good location to stimulate from. This theory is supported by observations from this substudy of the SMART AV trial in which the degree of delay to sensed LV at the pacing site was strongly associated with better outcomes. How this fits in with the importance of avoiding scar (also likely to be late) needs further explanation. Michael R Gold and others European Heart Journal (2011) 32, 2516–2524. The difference in driving regulations between different jurisdictions is quite striking. Using a modelled cut off of risk to others of 0.005%

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Comp ed by D ohn Pa sey & D Dan McKenz e

Follow me @danmckenzie73 for the latest reviews

The Drugs Don’t Work….. The search for a replacement for amiodarone goes on. Celivarone is a novel class 3 antiarrhythmic already known to be ineffective in atrial fibrillation, but thought to have some activity against ventricular arrhythmias. In a study of 486 patients with ICDs at high risk for ventricular arrhythmias Celivarone was no better than placebo at preventing arrhythmias.

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Much heat has been generated over the minority of warfarin patients with labile INRs, it is easy to forget that the majority achieve stable status. In a large comparison of four weekly vs. twelve weekly INRs in patients on stable warfarin therapy with no changes in dosing in the six months prior to enrolment the less frequent regime was safe and non inferior to more frequent testing. Sam Schulman and others Ann Intern Med. 2011;155:653-659. The big question with adverse risk associated with atrial fibrillation is whether it can mitigated by a rhythm control approach. One marker of poor outcome is renal function. In a Japanese study of 386 patients undergoing ablation of atrial fibrillation, the majority of whom had a degree of renal impairment, the 72% who maintained sinus rhythm showed improvement in biochemical renal function, whilst those with ongoing atrial fibrillation had ongoing deterioration. Yoshihide Takahashi and others Circulation. 2011;124:2380-2387.

12 Jan/Feb 2012 www.cardiologyhd.com

Management Hot Top c

Management

Hot Topic Do you believe that all radiographers either permanently based or rotating through should be classified as Band 6 - Senior Radiographer position? Superintendent Radiographer, Cardiac Catheter Suite King’s College Hospital NHS Trust LONDON

his is a very good question, and one that there are a number of ways of looking at. On the one hand, if you make working in a Catheter Lab as a Radiographer exclusively something for staff band 6 or above, you are excluding some very capable band 5 staff from the opportunity of doing so. However when things “go wrong” in Catheter Lab’s, you want staff with the experience and ability to cope under extreme pressure, and where someone’s life relies on their ability to do so. Some would argue that such experience is only found in staff banded at more Senior levels. My personal view is that there is no direct correlation between someone’s banding, and whether they will cope and adapt well to the pressures of working in a Catheter Lab. It is an area that some staff enjoy working in, and others do not. Having a structured approach to training, good competency assessment tools, a quality audit program (of images acquired), regular updates, and a no fault de-brief of any acute situations staff encounter will mean that staff at band 5 level can certainly operate confidently, competently and safely in such and environment.

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Ca d ac Rad og aphe Band ngs

Mr Greg Cruickshank

T

One final thought. I employ an Assistant Practitioner (band 4) to assist in the Pacing and EP lab. I had an AP helping out a while back whom was very new to the Cath Lab environment when he was involved in a case where the patient had an arrest that required prolonged resuscitation. He did a number of 2 minute cycles of chest compressions on the patient (having never done them on a real patient before), who thankfully went on to make a complete recovery. So impressed was the Consultant doing the case with his efforts, the next day he took the individual concerned up to the ward to see the patient, and told the her that this was the man who saved her life. The individual concerned has since gone on to qualify as a Radiographer (nearly 2 years ago), and is about to start his Angio/ PCI training as a Band 5 Radiographer. If it is ever my turn comes to have a procedure done in a Catheter lab, I hope that Radiographer is trained correctly, with regular audit, and is part of a team who work well together and enjoy their job. I really don’t mind at all what grade they are.

Having band 5 staff trained and competent means more flexibility in staffing service provision if you rely on Radiographers who rotate from Main Radiology like we do here at King’s, rather than having Cath Lab only staff like many other units have. Either way I believe that band 5 staff should have a role to play in the staff profile of a Catheter Lab. In the current economic climate, Senior Manager’s need to question what grade/banding profile is necessary to provide a safe and efficient service, and in my opinion this is certainly possible having some band 5 staff in the mix. I understand that others will have a different view. It would certainly be nice to be able to financially reward staff more for the jobs they do, however I do not think it necessary for staff to be at band 6 level to be capable of being competent to provide a safe service to patients, and to enjoy doing so.

14 Jan/Feb 2012 www.cardiologyhd.com

GE Healthcare United Kingdom

Site Visit Royal United Hospital Bath NHS trust Combe Park Bath BA1 3NG United Kingdom

What is the geographical intake area and population served by your hospital? Geographical intake is 550,000 people. How many staff? Roles? There are 5 Consultant Cardiologists, 1 Associate Specialist, 1 Registrar and 5 Junior Doctors. Types of procedures? Types of procedures include angiography, angioplasty, primary PCI, cardiac pacing, myoview, DSE and TOE. Angioplasty has access to IVUS, pressure wire, rotablation, Tornus, Proxis, and filter wire. Types and brands of equipment used? X-ray equipment is GE Innova including 2 labs, of which one is Biplane. IVUS is both Boston and Volcano. Echocardiography is supported by Vivid 7 and Vivid Q, and haemodynamics are provided by Mac Lab. Have you had any new equipment installed recently? Recently there has been a GE Biplane Innova system installed chosen partly because of excellent prior service support but also compatibility with existing x-ray equipment.

UK S te V s t

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Roya Un ed Hosp a Ba h

What are the sizes of your Cardiology Department and Hospital? Cardiology within the RUH is composed of a 28 bedded ward with an 8 bedded coronary care and 8 bedded day case units.

Leading the Healthcare [ r ] evolution

How many procedures are performed a year? During the course of 1 year there are approximately 400 angioplasty, 900 angiograms and 400 pacemakers. What is the approximate percentage of cath lab cases performed radially compared with femorally? Of angioplasty performed approximately 30% is radial versus femoral. Does your department offer a Primary Angioplasty Service?

For more information please contact:

David Britton Modality Manager david.britton@ge.com Tel 07831697463

Primary angioplasty is offered 7.00 am to 19.00 pm with the RUH but the consultants within the RUH participate in the Bristol regional service which provides 19.00pm to 7.00am primary PCI.

16 Jan/Feb 2012 www.cardiologyhd.com

© 2011 General Electric Company

What kind of training can new employees expect to receive? A period of being supernumery, they work towards a competency pack, in order to ensure staff are being trained in all areas and meeting standards required.

United Kingdom

Site Visit

What kinds of continuing education programs are available to staff? • •

Marlborough Rd Swindon SN3 6BB, United Kingdom

• • • •

Cardiology Matron

Cardiac Outpatients:

Cath lab Sister

10 Nurses WTE

Cardiac Physiologists 1 Waiting List Officers

• •

The Cardiology Department incorporates both emergency and elective work, offering a full range of investigations and procedures. Our Cath lab has just undergone a £3 million refurbishment which has seen us increase from 1 to 2 labs. This has helped us to be able to repatriate some of our complex pacing work and increase our activity. We have a 10 bedded recovery area which we also use for day case patients. We have a 14 bedded Acute Cardiac Unit and an 18 bedded Cardiology ward.

Radiographers 2.4 WTE ( 1 dedicated full time, the rest from rotational posts)

• •

What are the sizes of your Cardiology Department and Hospital? The Great Western Hospitals NHS Foundation Trust provides acute hospital services (at the Great Western Hospital) and community health and maternity services across Wiltshire and parts of Bath and North East Somerset. We have approximately 5,500 staff who pride themselves in delivering an outstanding service to patients and users.

How many procedures are performed a year?

Echo

Angiograms = 1330 PCI = 410 Pacemakers = 280

Stress Echo TOE Holter Monitoring Tilt Testing

What is the approximate percentage of cath lab cases performed radially compared with femorally? 60% Radially 40 % Femorally

12 Lead ECG’s Pacemaker Checks Cardiac CT

Does your department offer a Primary Angioplasty Service?

St Jude pressure wire

Boston iLab IVUS machine

• • • •

PPM Box Changes Reveals

We do an 8-4.30pm PPCI service, we have been doing this for approximately 2 years, with very good door to balloon times. We have no current plans to go 24/7. One of the issues was how PPCI would interrupt the work when we only had 1 lab, which at times was a challenge, but throughout we maintained good DTB times. This has now been resolved with our expansion to 2 labs.

Maquet IAPB 2 x Phillips IE33 1 x GE E9 1 x Vivid 7 Dimension 3D

1 x Vivid I

2 X GE Vscan

Have you had any new equipment installed recently?

Cardioversions

X-Ray Kit: Philips Allura FD10 x2 Physiological kit: Philips XIM (Xper Information Management) Archive: Xcelera Server for storing and viewing of our cardiac investigations.

ICD’s and CRT’s Pressure Wire Study IVUS

Angiograms (Inpatients and Outpatients) PCI ( In patients and Out patients) Permanent Pacemakers

• • • • •

Types of equipment used?

ACS Nurse 1 WTE Cardiac Rehab Nurses - 3 WTE

Types of procedures? We undertake elective • •

• •

Acute Cardiac Unit= 27 WTE Mercury Ward 39.5 Nurses WTE Heart Failure Nurses 1 WTE

• •

The critical care course Teaching and Assessing course Governance Study time monthly.

What is the best part of working at your facility? Working with a professional team, in a new environment which creates a happy working atmosphere. We receive very positive feedback from patients and have a low turn over of staff.

6 Consultant Cardiologists 2 SpRs 2 Staff grades

Industry Study days.

We allocate staff to stay late just in case we run over, this is then taken as time owing. What is you policy for company reps within the labs?

The Cath Lab Team First row: (L-R) Lisa Kostecka, Jacqueline Parry, Jacqui Tyzack , Sara Phillips, Darren Jordan 2nd row: Julie Mclea, Hristina Lacy-Hulbert, Emma Darke, Rebecca Saunders, Dr Tom Hyde, Dr William McCrea. 3rd row: Rachel Findlay, Stephanie Paul , Enrico Sibunga, Paul Frobisher, Francis Paran.

How many staff? Roles? We have: • •

We only book 1 rep per day to avoid any competitive companies, this is for education and for new products. All nice food donations are gratefully received!

What is the geographical intake area and population served by your hospital? We cover a large area including Swindon, North Wiltshire and parts of Gloucestershire, Oxfordshire and West Berkshire and saw over 460,000 patients last year. We are based closely to the M4 and have a helipad for the air ambulance.

How do you deal with late finishing of cases? For example staggered working hours or just staff overtime?

The Great Western Hospitals NHS Foundation Trust

We went through a tender and evaluation process and it was felt that the Phillips kit best met our requirements.

www.cardiologyhd.com

Jan/Feb 2012 19

20 Jan/Feb 2012 www.cardiologyhd.com

Above: Sister Jacqueline Parry What are the benefits to patients attending your facility? We offer a complete range of cardiac services which are delivered in a timely manner to meet all expected targets. Our recovery environment is new, light and airy with windows along one side. The patients will be dealt with by a friendly professional in a respectful way. We do have same sex bays to enhance the patients privacy and dignity while they are with us. How is your inventory managed? Currently we use barcodes when logging items during a procedure, and a spread sheet logging system for ordering and cross checking stock.

TR Bands for Radials Digital pressure/ Angioseals for Femorals

We have Femstops also available.

What measures has the department implemented to cut costs? As a department we are part of the South west regional tender which has helped us save money. Also having stock on a consignment basis has been cost effective.

We are now using Bivalirudin for our PPCI. We have started doing day case PPM and PCI, this has played a key part in being able to reduce our length of stay and patients would rather go home. Stress echo service has been commenced.

Below (from left): Jacqui Tyzack (Nurse), Lisa Kostecka (Nurse) and Dr William McCrea performing a coronary angiogram

How does the lab handle haemostasis? •

What new procedures / techniques have you implemented into the department recently? We have started to do CRT-P and CRT-D in our labs. This has been a significant development for our department and patients, as they prefer to be treated locally.

G ea Wes e n Hosp a Sw ndon

Changing some procedures to day cases has also help reduce length of stay which saves money, this has also helped improve patient experience as it means patients are back at home more quickly. www.cardiologyhd.com Jan/Feb 2012 21

Management Ass stance Manag ng Expec ations A S A P

Events Ca endar

Cover photograph courtesy o A Hou d ng Commun cations Roya Un ted Hosp ta Bath

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Great Western Hosp ta Sw ndon S te V s t

How to get n touch

@

Ema

Post

Co ona y Hea Pub sh ng L d Pe e House Ox o d S ee Manches e M1 5AN UK

C rcu ation

Ed o a Subsc ption & Gene a enqu es +44 0 845 299 6220

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Ed o a Subsc ption & Gene a enqu es adm n@co ona yhea com Adve tis ng enqu es adve tis ng@co ona yhea com

Phone

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Jan/Feb 2012 3


Our Cardiology

Experts Mr Tim Larner Director / Founder

Dr Magdi El-Omar Lead Consulting Editor

Dr Richard Edwards Consulting Editor

Prof Ahmed Magdy Consulting Editor (Middle East)

Previous Cardiac Radiographer Manager in Australia, & Senior Radiographer at multiple sites in the UK.

Consultant Cardiologist, Manchester Heart Centre, Central Manchester University Hospitals NHS Foundation Trust

Consultant Cardiologist, Freeman Hospital, Newcastle-upon-Tyne Hospitals NHS Trust

Head Unit Cardiology, Head CME National Heart Institute, Cairo Chairman, COMBATMI Program and Annual Meeting SCAI Member Board of Trustees

Dr John Paisey Journal Reviewer

Dr Dan McKenzie Journal Reviewer

Prof Simon Redwood Consulting Editor

Dr Rodney Foale Consulting Editor

Consultant Cardiologist, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Consultant Cardiologist, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust

Consultant Cardiologist & Director of the Cath Labs at Guy’s & St Thomas‘ NHS Foundation Trust

Consultant Cardiologist, Imperial College Healthcare NHS Trust

Ms Sophie Blackman Management & CRM Consulting Editor

Mr Ian Wright EP Consulting Editor

Mr Dennis Sandeman Nursing Consulting Editor

Dr Mojgan Sani

Technical Head EP, St Mary’s Hospital, Imperial College Healthcare NHS Trust

Chest Pain Nurse Specialist NHS Fife, Trustee of the Scottish Heart and Arterial Risk Prevention (SHARP) charity.

Head of Clinical Pharmacy, Royal Berkshire Foundation Trust & National Non-medical Prescribing Facilitator, National Prescribing Centre.

Head of Clinical Cardiac Physiology, West Hertfordshire NHS Trust

Pharmaceutical Editor

Copyright © 2006 - 2012 by Coronary Heart Publishing Ltd.

All rights reserved. Material may only be reproduced by prior arrangement and with due acknowledgment of Coronary Heart Publishing Ltd. The publication of an advertisement or product review does not imply that a product is recommended by Coronary Heart Publishing Ltd.

Mr Adam Lunghi Echo Consulting Editor

Stuart Allen Consulting Editor

Senior Echo Manager CVS - CardioVascular Services, Australia

Principal Cardiac Physiologist, Manchester Heart Centre, Manchester Royal Infirmary

4 Jan/Feb 2012 www.cardiologyhd.com

Disclaimer:

This publication should never be regarded as an authoritative peer reviewed medical journal. This publication has been designed as a guide only, to inform readers who work in the cardiology environment about latest news stories and the different techniques used by others around the world. Whilst all care is taken in reviewing articles obtained from various companies and contributors, it is not possible to confirm the accuracy of all statements. Therefore it is the reader’s responsibility that any advice provided in this publication should be carefully checked themselves, by either contacting the companies involved or speaking to those with skills in the specific area. Readers should always re-check claims made in this publication before employing them in their own work environment. Opinions expressed by contributors are their own and not necessarily those of their institution, Coronary Heart Publishing Ltd or the editorial staff.


Latest Product News

Round Up “Don’t Cut Your Tips” New program recycles whole EP catheters Catheter recycling created a buzz at the Heart Rhythm Congress meeting in Birmingham last October. EPreward, a U.S. company created and managed by an EP nurse, purchases whole diagnostic EP and ultrasound catheters thereby providing Cardiology Departments with additional funds for continuing education and other department needs. In the past, EP staff would cut the tips of EP catheters as part of a platinum recovery program. Now these departments are earning over four times more by selling their whole catheters to EPreward. “Brilliant” was used more than once to describe this new program. To verify this difference in earnings, a prominent NHS hospital conducted a side by side test using an identical batch of catheters. Payment from the London Refinery, EP Recyclers/Eco-Wires Recycling and EPreward’s platinum tip and whole catheter “Buy Back” program was determined for the same 345 catheters with the results shown below.

Hospital Earnings for an Identical Group of 345 EP Catheters The London Refinery Platinum Recovery

EP Recyclers/Eco-Wires Recycling Platinum Recovery

EPreward Platinum Recovery

EPreward Whole Catheter Buy Back

£ 651.79

£ 818.06

£ 1,445.90

£ 3,191.00

You can reach EPreward at contact@epreward.com or visit their website at www.epreward.com. EPreward documents every catheter and catheter tip, provides all collection materials and pays for shipping. Time to settlement is one week from the date of receipt. The EPreward website also contains over 75 FREE educational programs, a Training and Review section and much more. Don’t settle for less, receive the earnings you deserve with EPreward.

TAVI’s

Edwards Announce 2-Year PARTNER Trial Findings Edwards Lifesciences has announced two-year results of The PARTNER Trial Cohort B, a clinical study of inoperable patients with severe aortic stenosis treated with the Edwards SAPIEN transcatheter heart valve. These data demonstrated a widening survival benefit for SAPIEN patients at two years. At one year, all-cause mortality was 30.7% for transcatheter aortic valve implantation (TAVI) and 50.7% for standard therapy. At two years, TAVI patient mortality remained superior, with the curves diverging further to 43.3% versus 67.6%, respectively. SAPIEN patients spent significantly less time spent in hospital, with median days alive outside hospital of 699 compared with just 355 for standard therapy.

The trial studied 358 patients with severe, symptomatic aortic stenosis deemed inoperable for open-heart surgery. Patients were evenly randomized to receive either the SAPIEN valve or standard therapy. On November 2, the Edwards SAPIEN valve also became the first U.S. FDA approved transcatheter device enabling aortic valve replacement without the need open-heart surgery.

Right: Edwards SAPIEN XT valve

www.cardiologyhd.com

Jan/Feb 2012 5


Long-Term Clinical Benefits of BioMatrix Flex™ Confirmed in The Lancet: Proof of Concept for Biodegradable Polymer

New data published in The Lancet shows that BioMatrix Flex™, Biosensors’ Biolimus A9™-eluting stent system with a biodegradable polymer coating, significantly reduces the risk of very late stent thrombosis (VLST) compared to that of a drug-eluting stent (DES) system with a durable polymer coating after four years. This is positively associated with a reduced risk of cardiac events, therefore demonstrating for the first time ‘proof of concept’ that a DES with biodegradable polymer improves long-term clinical outcomes compared to a DES with durable polymer.

“This study shows that the problem of very late stent thrombosis, which was prevalent with first-generation durable-polymer drugeluting stents, is markedly reduced by a stent using a biodegradable polymer”, commented Principal Investigator Professor Stephan Windecker, University Hospital, Bern, Switzerland. “This translates into a late benefit in terms of cardiac death or myocardial infarction.” For more information visit www.biosensors.com.

Specialist Cardiac Staff Required Regent’s Park Heart Clinics Ltd. are actively recruiting for specialist cardiac staff. Employment opportunities are available within both an invasive and non-invasive cardiac setting. We are inviting applications for the following positions:

Radiographer (Cath Lab) - Scarborough This position is within a long term 2-day/week service (Tuesdays and Wednesdays) providing Diagnostic Coronary Angiography and Permanent Pacing.

RESEARCH IN CARDIOLOGY

Why, When, Where and How?

Cardiac Physiologist (Non-Invasive) - Cambridge

Friday 27th April 2012

This position is within a private patient facility operated by Regent’s Park called the Cambridge Heart Clinic, and requires the applicant to have the necessary skills to independently perform echocardiography, exercise testing and ambulatory monitoring. For more information visit: www.cambridgeheartclinic.co.uk

Royal College of Physicians, London

To find out more please contact Bryn Webber, Cardiac Services Director: bryn.webber@rphc.co.uk

A comprehensive one day symposium for all trainees considering a period of research towards attaining a PhD or MD. For more details and the full programme, visit the BCS website. Online registration is now open on www.bcs.com

Please visit our website for more details on our background and capabilities: www.rphc.co.uk We look forward to hearing from you.

6 Jan/Feb 2012 www.cardiologyhd.com

Run in association with the BCIS Research & Development Committee.


Siemens Healthcare supports the study of real life clinical cases with syngo.via The British Institute of Radiology (BIR), with technical support from Siemens Healthcare, has recently run a Cardiac CT level II1 course for visiting radiology professionals from Iraq. The four day course delivered training on the skills required to produce and interpret clinical cases and included the study of 150 cases using the Siemens’ syngo®. via imaging workstation application. Further Cardiac CT courses run by the BIR and supported by Siemens will be open to interested parties in February, July and September 2012. Russell Lodge, CT Business Manager at Siemens Healthcare states, “The hands-on sessions involving real-to-life cardiac CT cases help delegates to analyse and interpret major pathology groups including normal anatomy, anatomical variants, normal CT angiography, atherosclerotic CAD as well as post PCI and post surgery assessment.” The Cardiac CT courses are suitable for delegates that are performing cardiac imaging on any suitable CT platform and prior experience on Siemens syngo.via or CT scanners are not expected.

Dan Gibbons, Applications Specialist CT at Siemens Healthcare (left) and Dr. Ed Nicol, Consultant Cardiologist at Royal Brompton and Harefield NHS Foundation Trust and BIR Cardiac CT Course Director (right) discuss real life cardiac CT case examples with visiting radiology delegates from medical institutions in Iraq.

For further information on the planned courses for 2012, please visit www.bir.org.uk.

Cardiology Ad-Final_Template 07/10/2011 14:31 Page 1

Wednesday 18th January 2012

Maple House, Birmingham

Reinvigorate your practices and relieve your pressures

Optimising Cardiac Physiology Services Improve efficiency, share workforce solutions and deliver community services

Hear about the latest changes, exchange best practice, listen to innovative case studies and network with your peers: • Eradicate bottlenecks: implement cardiac physiologist led rapid access clinics and improve access, and savings through one-stop • Invest to save: share QIPP strategies and build a business case to invest in remote monitoring • Transform your workforce: make Modernising Scientific Careers work, improve productivity through Assistant Practitioners and implementing a 24/7 primary angioplasty service • Deliver services in the community: share commissioning plans and reconfigure to achieve satellite services

BOOK YOUR PLACE NOW Tel: 01732 89 77 88 Fax: 01732 44 80 47 bookings@sbk-healthcare.co.uk | www.sbk-healthcare.com

Take away ideas from the trailblazers and adapt them to your own trust: • City Hospitals Sunderland NHS Foundation Trust • The Newcastle upon Tyne Hospitals NHS Foundation Trust • South Tees Hospitals NHS Foundation Trust • The Royal Berkshire NHS Foundation Trust • NHS Improvement Benefit from this practical case study driven day

NHS SPeCIAl PRICe

ONLY £299 each When 2 places booked

www.cardiologyhd.com Jan/Feb 2012  7


The following articles are courtesy of NHS Choices

Behind The Headlines

The Facts Imaging

Study rates heart scan techniques “Magnetic resonance imaging (MRI) scans should be used to assess patients with suspected heart disease, rather than standard checks,” reports BBC News today. This story is based on a large, well-designed study comparing a new technique called cardiovascular magnetic resonance (CMR) imaging against the commonly used alternative test, single-photon emission computed tomography (SPECT). The researchers tested the scan’s ability to diagnose significant coronary heart disease, also looking at how they compared against standard angiography, where dye is introduced into the blood vessels to highlight any blockage or narrowing. The study found that CMR performed as well or better than SPECT on a number of key diagnostic measures. Together with the fact that CMR does not expose patients to ionising radiation, the researchers say the results show that CMR should be more widely adopted. However, CMR will not be suitable for all patients, including some with medical implants and those who could experience claustrophobia inside the scanner. Further research will also be needed to demonstrate that improved diagnosis through techniques such as CMR actually improves patient outcomes. That said, these results do suggest the technique has merit. The study was carried out by researchers from the University of Leeds and was funded by the British Heart Foundation. The study was published in the peer-reviewed journal The Lancet.

Confusion over salt research “Salt is good for us after all,” according to the Daily Express. The newspaper said that a “controversial new study suggests that salt in the diet can lessen our chances of suffering heart disease and strokes”. The Express story itself should be taken with a large pinch of salt, as the study doesn’t suggest that eating high levels of salt is good for us. Instead, the research found that in white people with normal blood pressure, a low-salt diet only slightly reduced blood pressure but led to small increases in substances such as cholesterol.

8 Jan/Feb 2012 www.cardiologyhd.com

Stem cells may aid heart repair The Daily Telegraph reported that it may be possible for patients to use their own stem cells to repair the damage caused by heart attacks. The newspaper said that heart repair with stem cells could be the “biggest breakthrough in a generation”. The news is based on a small safety trial that tested whether people with heart failure could have stem cells extracted from their heart, grown in a lab and safely injected back into the heart. The study, which is still in progress, found that the treatment did not lead to any negative effects in the year after treatment. Participants also saw improvements in heart function, scarring and quality of life compared with before treatment. A group of volunteers with heart failure who were not given the treatment showed no improvements in the symptoms of their heart failure. This trial has shown another potential application for stem cells, which are at the forefront of medical research. However, the study was designed to look at safety rather than effectiveness, and was, accordingly, short and small. Given the limited nature of the trial, larger, longer trials will now be required to see whether these initially promising results can be replicated and whether the technique will prove safe and effective in the long-term. The study was funded by The University of Louisville Research Foundation and the US National Institutes of Health. It was carried out by the University of Louisville with lab work conducted by Brigham & Women’s Hospital, a teaching hospital affiliated with Harvard Medical School. It was published in the peer-reviewed medical journal The Lancet. The Daily Mail and The Daily Telegraph covered this study, with both highlighting that it was preliminary research that involved a small number of patients only.

The study itself was designed to pool and analyse the results of previous studies to determine how low-salt and high-salt diets affected blood pressure and a range of substances in the blood. Crucially though, many of the studies included in the review lasted only a few weeks and none were designed to look at the effect of salt reduction on longer-term health outcomes such as heart disease and stroke. Salt reduction is often intended to be a long-term measure, and therefore results looking at the practice over longer periods would be preferable. The Daily Express headline, “Salt is good for us after all” is therefore misleading. Both the Express and The Daily Telegraph included comments from external experts in their reports, some of which were critical of the study.


25

point improvement

BALLOON-EXPANDABLE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI)

in QoL scores at one year1 STANDARD MEDICAL THE

RAPY*

A new option for your aortic stenosis patients who cannot undergo surgery In Cohort B of the landmark clinical study—The PARTNER Trial—patients receiving an Edwards SAPIEN balloon expandable transcatheter valve demonstrated a 25-point improvement in quality of life scores compared to the standard medical therapy control group at one year.1 In addition to a large survival benefit2, the improvement in physical health with TAVI was equivalent to reversing by 10 years the normal decline in physical health observed with aging in general population1. For more information and to find a TAVI center near you, please visit edwards.com/eu/products/transcathetervalves. * Patients in control arm received best medical management which frequently (78.2%) included balloon aortic valvuloplasty. References: 1. Reynolds MR et al; PARTNER Trial Investigators. Health-Related Quality of Life After Transcatheter Aortic Valve Replacement in Inoperable Patients With Severe Aortic Stenosis. Circulation 2011;124:1964-1972 2. Leon MB, Smith CR, Mack M, et al; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607.7. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events. Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, SAPIEN and PARTNER are trademarks of Edwards Lifesciences Corporation. © 2011 Edwards Lifesciences Corporation. All rights reserved. E2394/10-11/THV

Edwards Lifesciences Irvine, USA I Nyon, Switzerland edwards.com

I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil


GE Healthcare

For difficult-to-image patients, a simple-to-use solution The challenge of technically difficult echocardiography studies

Optison can improve diagnostic accuracy and clinical confidence

It has been estimated that 10%-15% of routine echocardiograms have incomplete endocardial resolution, making these studies difficult to interpret.1 The proportion may be even higher during stress echocardiography, with suboptimal images in up to one third of patients.2

Optison was highly effective, even in patients with chronic lung disease or dilated cardiomyopathy.4 Improvement in EBD by one or more segments4 All patients

Microbubble contrast agents can expand the diagnostic utility of echocardiography in such technically difficult studies.1

p<0.001

100

% patients

p<0.001

94%

93%

80

High-resolution image of endocardial border delineation (EBD)

Patients with chronic lung disease or cardiomyopathy

77%

74%

60 40 20 0

Unenhanced

177/190

142/193

Optison 3.0 ml (optimal dose as per study) *Albunex is no longer available in the EU Adapted from Cohen 19984

Contrast-enhanced

Images courtesy of Rush University Medical Center, Chicago

65/69

54/70

Albunex* 0.22 ml/kg

Improving visualisation improves patient management

Full (100%) left ventricle opacification was achieved in 87% of all patients and also 87% of the impaired function subgroup with Optison 3.0 ml.4 Conversion of non-diagnostic to diagnostic echocardiograms occurred in 74% of all patients with Optison 3.0 ml.4

By improving visualisation, contrast enhancement can reduce downstream utilisation of alternative testing resources.3

Optison is simple to administer Easy resuspension allows quick access to contrast in the lab or on the go.5 No vial mixer is required – instead, simply invert the vial or gently rock-and-roll between your palms to resuspend.5

Impact of contrast on patient management1 2.2 8.2

25.2

64.4

Optison is stable at room temperature for up to 24 hours.5 0

20

40

60

80

100

% patients n=632 consecutive patients with technically difficult studies Procedure avoided only Medication change only Both medication and procedural change Unchanged Adapted from Figure 6, Kurt 20091

Recommended by the European Association of Echochardiography

The use of ultrasound contrast agents is recommended by the European Association of Echocardiography when two or more contiguous segments are not well visualised on non-contrast images.2

10 Jan/Feb 2012 www.cardiologyhd.com

It can be repeatedly resuspended throughout the day and returned to proper storage if unused. Optison can be safely placed back in the refrigerator a maximum of five times before the expiry date.6 Customer service contact details

To order Optison or to find out more please use the following details:

Freephone: 0800 55 88 22 Freefax:

0800 66 99 33

Email:

ukcsorders@ge.com


PRESCRIBING INFORMATION OPTISON™ 0.19 mg/ml dispersion for injection (Human albumin microspheres containing perflutren) Please refer to full Summary of Product Characteristics before prescribing. PRESENTATION Dispersion for injection supplied as 1 vial of 3 ml and 5 vials of 3 ml. OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in human albumin solution, 1%. CONCENTRATION Perflutren-containing microspheres, 5-8 x 108/ml with a mean diameter range of 2.5-4.5 μm. The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg. INDICATIONS This medicinal product is for diagnostic use only. OPTISON is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular endocardial border delineation with resulting improvement in wall motion visualisation. OPTISON should only be used in patients where the study without contrast enhancement is inconclusive. DOSAGE AND METHOD OF ADMINISTRATION OPTISON should only be administered by physicians experienced in the field of diagnostic ultrasound imaging. Before administering OPTISON, please see Instructions for use. The product is intended for left ventricular opacification after intravenous administration. Ultrasound imaging must be performed during injection of OPTISON as optimal contrast effect is obtained immediately after administration. Dosage: The recommended dose is 0.5-3.0 ml per patient. A dose of 3.0 ml is usually sufficient, but some patients may need higher doses. The total dose should not exceed 8.7 ml per patient. The duration of the useful imaging time is 2.5-4.5 minutes for a dose of 0.5-3.0 ml. OPTISON could be repeatedly administered, however, clinical experience is limited. Safety and efficacy of OPTISON in children and adolescents below 18 years has not been established; no recommendation on a posology can be made. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. Pulmonary hypertension with a systolic pulmonary artery pressure > 90 mm Hg. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Hypersensitivity has been reported. Care should therefore be exercised. A course of action should be planned in advance with necessary drugs and equipment available for immediate treatment, in case a serious reaction should occur. The experience of OPTISON in severely ill patients is limited. There is limited clinical experience with OPTISON in patients with certain severe states of cardiac, pulmonary, renal and hepatic disease. Such clinical states include adult respiratory distress syndrome, the use of artificial respiration with positive end-expiratory pressure, severe heart failure (NYHA IV), endocarditis, acute myocardial infarction with on-going angina or unstable angina, hearts with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation system and/or recurrent thromboembolism, renal or hepatic end-stage disease. OPTISON should be used in these categories of patients only after careful consideration, and monitored closely during and after administration. Other routes of administration not specified in section “Dosage and method of administration” above (e.g. intracoronary injection) are not recommended. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes. It is strongly recommended that every time that OPTISON is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product. OPTISON contrast echocardiography should be accompanied by ECG monitoring. In animal studies, the application of echo-contrast agents revealed biological side effects (e.g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam. Although these biological side effects have not been reported in humans, the use of a low mechanical index and end-diastolic triggering is recommended. Efficacy and safety in patients below 18 years has not been studied. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. Use during anaesthesia with halothane and oxygen has not been studied. PREGNANCY AND LACTATION The safety of OPTISON for use during human pregnancy has not been established. In pregnant rabbits exposed to daily doses of 2.5 ml/kg (approximately 15 x the maximum recommended clinical dose) during organogenesis, maternal toxicity and embryo-foetal toxicity including a slight to extreme dilation of ventricles in the brain of developing rabbit embryos was observed. The clinical relevance of this finding is unknown. Therefore, OPTISON should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the physician. It is not known whether OPTISON is excreted in human milk. Therefore, caution should be exercised when OPTISON is administered to breast-feeding women. EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES No studies on the effects on the ability to drive and use machines have been performed. UNDESIRABLE EFFECTS Adverse reactions to OPTISON are rare and usually of a non-serious nature. In general, the administration of human albumin has been associated with transient altered taste, nausea, flushing, rash, headache, vomiting, chills and fever. Anaphylactic reactions have been associated with the administration of human albumin products. The reported adverse events following the use of OPTISON in Phase III human clinical studies have been mild to moderate with

subsequent full recovery. In clinical trials with OPTISON, undesirable effects were reported as adverse events with the following frequencies: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1,000 to <1/100; Rare ≥1/10,000 to <1/1,000; Very rare <1/10,000; not known (cannot be estimated from the available data). Undesirable effects: Common: Dysgeusia (altered taste), headache, flushing, nausea, warm sensation. Uncommon: Eosinophilia, dyspnoea, chest pain. Rare: Dizziness, paraesthesia, tinnitus, ventricular tachycardia. Not Known: Visual disturbances, allergic type symptoms (e.g. anaphylactoid reaction or -shock, facial oedema, urticaria). OVERDOSE No case of overdose has been reported. In the phase I trial, healthy volunteers have received up to 44.0 ml of OPTISON and experienced no significant adverse effects. INSTRUCTIONS FOR USE AND HANDLING Like all parenteral products, the vials of OPTISON should be inspected visually for integrity of the container. Vials are intended for single use only. Homogenous white suspension after resuspension. Once the rubber stopper has been penetrated, the contents should be used within 30 minutes and any unused product discarded. OPTISON in the nonresuspended form has a white layer of microspheres on top of the liquid phase that requires resuspension before use. The following instructions should be followed: • Cold solutions taken directly from the refrigerator should not be injected. • Allow the vial to reach room temperature and inspect the liquid phase for particulate matter or precipitates before resuspension. • Insert a 20 G plastic cannula in a large antecubital vein, preferably of the right arm. Attach a three-way stopcock to the cannula. • The OPTISON vial must be inverted and gently rotated for approximately three minutes to completely resuspend the microspheres. • Complete resuspension is indicated by a uniformly opaque white suspension and absence of any material on stopper and vial surfaces. • OPTISON should be withdrawn with care into a syringe within 1 minute after resuspension. • Any pressure instability within the vial should be avoided since it may cause disruption of microspheres and loss of contrast effect. Thus, vent the vial with a sterile spike or with a sterile 18 G needle before withdrawing the suspension into the injection syringe. Do not inject air into the vial as this will damage the product. • Use the suspension within 30 minutes after withdrawal. • OPTISON will segregate in an undisturbed syringe and must be resuspended before use. • Resuspend the microspheres in the syringe immediately before injection by holding the syringe horizontally between the palms of the hands and rolling it quickly back and forth for no less than 10 seconds. • Inject the suspension through the plastic cannula, no smaller than 20 G at a maximum injection rate of 1.0 ml/s. Warning: Never use any other type of route but the open flow connection. If injected otherwise OPTISON bubbles will be destroyed. • Immediately before injection a careful visual inspection of the syringe is mandatory in order to ensure complete suspension of the microspheres. • Immediately after injection of OPTISON, 10 ml of sodium chloride 9mg/ml (0.9%) solution for injection or glucose 50mg/ml (5%) solution for injection should be injected at a rate of 1 ml/s. Alternately, the flushing may be performed by infusion. The infusion set should then be attached to the three-way stopcock and intravenous infusion started at a “to keep open” (TKO) rate. Immediately after OPTISON injection the intravenous infusion should be wide open until contrast begins to fade from the left ventricle. The infusion should then be returned to a TKO rate. PHARMACEUTICAL PRECAUTIONS OPTISON must not be mixed with other medicinal products. A separate syringe should be used. OPTISON should be stored upright between 2ºC and 8ºC. Storage at room temperature (up to 25ºC) for 1 day is acceptable. Do not freeze. The shelf life of the product in the outer packaging is 2 years and of finished product after rubber stopper perforation: 30 minutes. MARKETING AUTHORISATION HOLDER GE Healthcare AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, N-0401 OSLO, Norway. CLASSIFICATION FOR SUPPLY Subject to medical prescription. MARKETING AUTHORISATION NUMBERS 1 x 3 ml: EU/1/98/065/001. 5 x 3 ml: EU/1/98/065/002. PRICE 5x3 ml: £286.30. Revision of text December 2010. Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to GE Healthcare. GE Healthcare Limited, Amersham Place, Little Chalfont, Buckinghamshire, England HP7 9NA www.gehealthcare.com

© 2011 General Electric Company – All rights reserved. GE and GE Monogram are trademarks of General Electric Company. GE Healthcare, a division of General Electric Company. Optison is a trademark of GE Healthcare Limited. References: 1. Kurt MG et al. J Am Coll Cardiol 2009; 9: 802-10. 2. Senior R et al. Eur J Echocardiogr 2009; 10: 194-212. 3. Dwivedi G et al. Eur J Echocardiogr 2009; 10: 933-40. 4. Cohen JL et al. J Am Coll Cardiol 1998; 32: 746-52. 5. Optison Summary of Product Characteristics. 6. Data on file, GE Healthcare.

GE Healthcare Limited Amersham Place, Little Chalfont Buckinghamshire, England HP7 9NA www.gehealthcare.com

05-2011 JB4528/LoremIpsum UK & INT’L ENG


Journals Dr John Paisey Journal Reviewer

Dr Dan McKenzie Journal Reviewer

Consultant Cardiologist, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Consultant Cardiologist, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust

Follow me @johnpaisey for the latest reviews

Follow me @danmckenzie73 for the latest reviews

The Drugs Don’t Work….. The search for a replacement for amiodarone goes on. Celivarone is a novel class 3 antiarrhythmic already known to be ineffective in atrial fibrillation, but thought to have some activity against ventricular arrhythmias. In a study of 486 patients with ICDs at high risk for ventricular arrhythmias Celivarone was no better than placebo at preventing arrhythmias. Peter R Kowey and others Circulation. 2011;124:2649-2660. Does adding clopidogrel to aspirin in patients unable to take warfarin for stroke prevention in AF make any difference? Not really. Stuart Connolly and others Ann Intern Med. (2011) 155: 9; 579-586.

Or do they? Long term (22 years) follow up data from the SHEP (Systolic Hypertension in the Elderly Program) study has shown that chlorthalidone +/- atenolol treatment significantly improves mortality, gaining about one day of extra life per month of taking the treatment.

the authors surmise that following an appropriate therapy private drivers should be banned for 2-4 months, but that no interruption in driving is required after elective implant or revision, or after an inappropriate shock which is programmed around. Professional driving however would be prohibited for life. This certainly contrasts markedly with UK regulations where certain professional drivers are allowed to continue, but other low risk circumstances attract bans of between one and six months. Joep Thijsson and others European Heart Journal. 2011; 32, 2678–2687. We have discussed before the difficulties in translating the obvious potential of transthoracic impedance monitoring in implantable devices into a useful heart failure monitoring tool. The DOT-HF investigated whether an audible and physician alert alarms could alter the risks of heart failure events. The trial struggled with enrolment, but a post hoc analysis after 335 patients were included and followed up revealed there was unlikely to be any demonstrable benefit of the monitoring regime. Clearly, further work is required for us to be able to understand how to use these tools. Dirk J. van Veldhuisen and others Circulation. 2011;124:1719-1726.

Stroke Risk and Anticoagulation Implantable Devices CRT (probably) works by making the latest contracting part of the left ventricle (LV) contract closer to simultaneously with the rest of the ventricles. Measuring the delay from QRS onset to the sensed LV electrogram should identify both the potential benefit of retiming (more delay, more dysynchrony) and selection of a good location to stimulate from. This theory is supported by observations from this substudy of the SMART AV trial in which the degree of delay to sensed LV at the pacing site was strongly associated with better outcomes. How this fits in with the importance of avoiding scar (also likely to be late) needs further explanation. Michael R Gold and others European Heart Journal (2011) 32, 2516–2524. The difference in driving regulations between different jurisdictions is quite striking. Using a modelled cut off of risk to others of 0.005%

12 Jan/Feb 2012 www.cardiologyhd.com

Much heat has been generated over the minority of warfarin patients with labile INRs, it is easy to forget that the majority achieve stable status. In a large comparison of four weekly vs. twelve weekly INRs in patients on stable warfarin therapy with no changes in dosing in the six months prior to enrolment the less frequent regime was safe and non inferior to more frequent testing. Sam Schulman and others Ann Intern Med. 2011;155:653-659. The big question with adverse risk associated with atrial fibrillation is whether it can mitigated by a rhythm control approach. One marker of poor outcome is renal function. In a Japanese study of 386 patients undergoing ablation of atrial fibrillation, the majority of whom had a degree of renal impairment, the 72% who maintained sinus rhythm showed improvement in biochemical renal function, whilst those with ongoing atrial fibrillation had ongoing deterioration. Yoshihide Takahashi and others Circulation. 2011;124:2380-2387.


Do patients receiving anticoagulation still have graded risk according to CHADS2 score? Yes, and what’s more, a higher CHADS2 score also predicts bleeding complications. Jonas Oldgren and others (a RE-LY substudy) Ann Intern Med. 2011, 155 10; 660-667.

Imaging Cardiac imaging goes from strength to strength. A South Korean group has shown that coronary CT angiography (CCTA) can be combined with ‘virtual’ fractional flow reserve (FFR) studies to identify stenosis and whether or not they are ischaemic with a single noninvasive study. If this can be shown to influence treatment decisions (in the ongoing DEFACTO trial) and be low risk (i.e. combined with low ionising radiation exposure), the clinical implications would be huge. Bon Kwon-Koo and others. J Am Coll Cardiol 2011;58:1989-97. Another group from Leeds compared cardiovascular magnetic resonance (CMR) against single-photon emission CT (SPECT) for the diagnosis of coronary artery disease in a prospective (CE-MARC) study of 752 patients, all of whom underwent diagnostic coronary angiography as the ‘gold standard’ comparator. CMR was better than SPECT at identifying coronary artery disease and equivalent at ruling it out. John Greenwood and others. The Lancet 2011DOI: 10.1016/ S0140-6736(11)61335-4.

er bleeding risk patients – disadvantages include BD dosing. The data for Rivaroxaban is weakest, but it still has better bleeding outcomes than warfarin. Advantages include once daily dosing and NICE verdict soon. They all cost more, but probably no difference once other costs are taken into account (NICE agreed with provisional cost data from Dabigatran) and are difficult to reverse. Stuart Connolly and others. N Eng J Med. 2009;361:1139-1151. Manesh Patel and others. N Eng J Med. 2011;365:883-891. Stuart Connolly and others. N Eng J Med. 2011;364:806-817. Christopher Granger and others. N Eng J Med. 2011;365:981-992.

American’s We chuckled to see that the Americans are still questioning whether PCI in sites without on-site back up cardiothoracic surgery is safe. This, although originally questioned, has been common practice in the UK for years and is known to have good clinical outcomes, provided reasonable operator and institutional numbers are maintained. A meta-analysis of 15 controlled studies shows that patients undergoing PCI at centers without on-site surgery capabilities are no more likely to die or need emergency bypass coronary surgery than comparable patients treated at centers with on-site surgery capabilities. Our state side friends also lag behind in terms of performing PCI via the radial artery. Happy Christmas to all! M Singh and others. JAMA 2011;306:2487-2494.

Summary of the ‘New’ Anticoagulants As we come to the end of 2011, we felt a summary of the trials on the new anticoagulants may be helpful, as these look to be a real game changer in clinical medicine. There are three drugs that have produced positive trial data: Dabigatran, Rivaroxaban and Apixaban. Dabigatran is a direct thrombin inhibitor, 110mg BD low dose or 150mg BD high dose, is renally cleared and was tested in the RELY trial vs Warfarin. The 150mg BD dose reduces strokes (the only one that reduces this endpoint on it’s own), combined CVA/systemic embolism and intra cerebral haemorrhage (ICH) with similar bleeding to Warfarin i.e. it is better, but costs 10 x as much (£4.20 a day) and has no reversing agent. As with all of the new agents there are no monitoring costs. The 110mg BD dose has similar stroke outcomes to warfarin, but reduced ICH and bleeding compared to warfarin. It received NICE approval in November, as a treatment option in AF and ACC/AHA guideline Class I at the higher dose. Rivaroxaban is a factor Xa inhibitor (like fondaparinux), 20mg OD dose, renally cleared and was tested in the ROCKET-AF trial vs. Warfarin. It was shown to be non-inferior to Warfarin for CVA with reduced ICH. Only on-treatment analysis was favourable. Again it is significantly more expensive. NICE verdict due May 2012. Apixaban is another factor Xa inhibitor, 5mg bd dose, only 30% renally cleared and was tested in the AVERROES trial vs. Aspirin, and the ARISTOTLE trial vs. Warfarin. Apixaban has better ischaemic outcomes than Aspirin with similar bleeding (i.e. it is better), but obviously more expensive. It has better combined (stroke and systemic embolism) outcomes than warfarin with reduced mortality and reduced intracranial haemorrhage i.e. it is better, but more expensive and not yet NICE approved (no date yet either). Our initial feelings are that Apixaban has the best data of the three, but is twice daily dosing and not yet NICE approved. Dabigatran is better than warfarin, is NICE approved and has the advantage of two doses – one for high ishaemic risk patients and a lower dose for high-

AVAILABLE ONLINE

You can read this Journal Trawl as well as all previous versions on our website at www.cardiologyhd.com.

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Jan/Feb 2012 13


Management

Hot Topic Do you believe that all radiographers either permanently based or rotating through should be classified as Band 6 - Senior Radiographer position? Mr Greg Cruickshank Superintendent Radiographer, Cardiac Catheter Suite King’s College Hospital NHS Trust LONDON

T

his is a very good question, and one that there are a number of ways of looking at. On the one hand, if you make working in a Catheter Lab as a Radiographer exclusively something for staff band 6 or above, you are excluding some very capable band 5 staff from the opportunity of doing so. However when things “go wrong” in Catheter Lab’s, you want staff with the experience and ability to cope under extreme pressure, and where someone’s life relies on their ability to do so. Some would argue that such experience is only found in staff banded at more Senior levels. My personal view is that there is no direct correlation between someone’s banding, and whether they will cope and adapt well to the pressures of working in a Catheter Lab. It is an area that some staff enjoy working in, and others do not. Having a structured approach to training, good competency assessment tools, a quality audit program (of images acquired), regular updates, and a no fault de-brief of any acute situations staff encounter will mean that staff at band 5 level can certainly operate confidently, competently and safely in such and environment.

One final thought. I employ an Assistant Practitioner (band 4) to assist in the Pacing and EP lab. I had an AP helping out a while back whom was very new to the Cath Lab environment when he was involved in a case where the patient had an arrest that required prolonged resuscitation. He did a number of 2 minute cycles of chest compressions on the patient (having never done them on a real patient before), who thankfully went on to make a complete recovery. So impressed was the Consultant doing the case with his efforts, the next day he took the individual concerned up to the ward to see the patient, and told the her that this was the man who saved her life. The individual concerned has since gone on to qualify as a Radiographer (nearly 2 years ago), and is about to start his Angio/ PCI training as a Band 5 Radiographer. If it is ever my turn comes to have a procedure done in a Catheter lab, I hope that Radiographer is trained correctly, with regular audit, and is part of a team who work well together and enjoy their job. I really don’t mind at all what grade they are.

Having band 5 staff trained and competent means more flexibility in staffing service provision if you rely on Radiographers who rotate from Main Radiology like we do here at King’s, rather than having Cath Lab only staff like many other units have. Either way I believe that band 5 staff should have a role to play in the staff profile of a Catheter Lab. In the current economic climate, Senior Manager’s need to question what grade/banding profile is necessary to provide a safe and efficient service, and in my opinion this is certainly possible having some band 5 staff in the mix. I understand that others will have a different view. It would certainly be nice to be able to financially reward staff more for the jobs they do, however I do not think it necessary for staff to be at band 6 level to be capable of being competent to provide a safe service to patients, and to enjoy doing so.

14 Jan/Feb 2012 www.cardiologyhd.com

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annual conference Date: 28 to 30 May 2012 Venue: Manchester Central Free registration for BCS Members before 30 April 2011. Abstract submission deadline 23:59pm 1 December 2011. Visit www.bcs.com for online registration and programme.


Photographs courtesy of A Houlding, Communications, Royal United Hospital Bath

United Kingdom

Site Visit Royal United Hospital Bath NHS trust Combe Park Bath BA1 3NG United Kingdom

What are the sizes of your Cardiology Department and Hospital? Cardiology within the RUH is composed of a 28 bedded ward with an 8 bedded coronary care and 8 bedded day case units. What is the geographical intake area and population served by your hospital? Geographical intake is 550,000 people. How many staff? Roles? There are 5 Consultant Cardiologists, 1 Associate Specialist, 1 Registrar and 5 Junior Doctors. Types of procedures? Types of procedures include angiography, angioplasty, primary PCI, cardiac pacing, myoview, DSE and TOE. Angioplasty has access to IVUS, pressure wire, rotablation, Tornus, Proxis, and filter wire. Types and brands of equipment used? X-ray equipment is GE Innova including 2 labs, of which one is Biplane. IVUS is both Boston and Volcano. Echocardiography is supported by Vivid 7 and Vivid Q, and haemodynamics are provided by Mac Lab. Have you had any new equipment installed recently? Recently there has been a GE Biplane Innova system installed chosen partly because of excellent prior service support but also compatibility with existing x-ray equipment. How many procedures are performed a year? During the course of 1 year there are approximately 400 angioplasty, 900 angiograms and 400 pacemakers. What is the approximate percentage of cath lab cases performed radially compared with femorally? Of angioplasty performed approximately 30% is radial versus femoral. Does your department offer a Primary Angioplasty Service? Primary angioplasty is offered 7.00 am to 19.00 pm with the RUH but the consultants within the RUH participate in the Bristol regional service which provides 19.00pm to 7.00am primary PCI.

16 Jan/Feb 2012 www.cardiologyhd.com


GE Healthcare

Leading the Healthcare [ r ] evolution For more information please contact:

David Britton Modality Manager david.britton@ge.com Tel 07831697463

Š 2011 General Electric Company


What new procedures / techniques have you implemented into the department recently? In terms of new procedures we have IVUS, pressure wire, rotablation and thrombectomy strategies with the intention to include devices (CRT and defibrillation) in due course and potentially look at an EP facility at some point.

What kinds of continuing education programs are available to staff? Continued education is supplied by formal Friday lunchtime meetings and echocardiographic grand rounds. Please outline the Department Management structure.

Cutting edge cardiology care delivered locally!

Departmental Management structure is Cardiologists with a nominated Clinical Lead who answers to Chair of Medical Division. Cardiology itself has a Ward Sister as well as a lead Physiologist whose Line Manager is Nursing Matron.

How is your inventory managed?

How do you deal with late finishing of cases?

Inventory is managed by barcodes but supervised by one our cardiac physiologists.

The intention is to only put patients on the table which one realistically can finish; however, if this does run over it is covered by the oncall team who would typically be available for primary angioplasty, although both nursing staff and physiologists are routinely on a rota to work until 18.00pm, start time is 8.00am.

What are the benefits to patients attending your facility?

How does the lab handle haemostasis? Haemostasis is managed predominately by Angioseal for femoral interventional cases, TR band for radial interventional cases and manual pressure by nursing staff for diagnostic or non-Heparinised cases. What measures has the department implemented to cut costs? In order to cut cost we have actively sought inclusion in regional tendering processes but also evaluated efficiency on a rolling basis within the departments. What kind of training can new employees expect to receive? New employees within the department can expect to be involved in an active training programme depending on whether they are medical or physiology or indeed nursing staff based.

18â&#x20AC;&#x192;Jan/Feb 2012â&#x20AC;&#x192;www.cardiologyhd.com

What is you policy for company reps within the labs? Company reps are welcomed but must have booked and are seen in accordance with current BECIS guidelines with patient permission sought if the rep intends to be within the clinical lab environment. Reps are encouraged to bring food and support the Friday meeting with an opportunity to discuss their particular interest. What is the best part of working at your facility? The best parts of working at the facility are the people who do the work who really are an excellent team and make it not just tolerable but worthwhile and enjoyable on the whole.


United Kingdom

Site Visit The Great Western Hospitals NHS Foundation Trust Marlborough Rd Swindon SN3 6BB, United Kingdom

What is the geographical intake area and population served by your hospital? We cover a large area including Swindon, North Wiltshire and parts of Gloucestershire, Oxfordshire and West Berkshire and saw over 460,000 patients last year. We are based closely to the M4 and have a helipad for the air ambulance. How many staff? Roles? We have:

What are the sizes of your Cardiology Department and Hospital? The Great Western Hospitals NHS Foundation Trust provides acute hospital services (at the Great Western Hospital) and community health and maternity services across Wiltshire and parts of Bath and North East Somerset. We have approximately 5,500 staff who pride themselves in delivering an outstanding service to patients and users. The Cardiology Department incorporates both emergency and elective work, offering a full range of investigations and procedures. Our Cath lab has just undergone a £3 million refurbishment which has seen us increase from 1 to 2 labs. This has helped us to be able to repatriate some of our complex pacing work and increase our activity. We have a 10 bedded recovery area which we also use for day case patients. We have a 14 bedded Acute Cardiac Unit and an 18 bedded Cardiology ward.

6 Consultant Cardiologists

2 SpRs

2 Staff grades

Cardiology Matron

Cath lab Sister

10 Nurses WTE

Radiographers 2.4 WTE ( 1 dedicated full time, the rest from rotational posts)

Cardiac Physiologists

1 Waiting List Officers

Acute Cardiac Unit= 27 WTE

Mercury Ward 39.5 Nurses WTE

Heart Failure Nurses 1 WTE

ACS Nurse 1 WTE

Cardiac Rehab Nurses - 3 WTE

Types of procedures? We undertake elective •

Angiograms (Inpatients and Outpatients)

PCI ( In patients and Out patients)

Permanent Pacemakers

PPM Box Changes

Reveals

Cardioversions

ICD’s and CRT’s

Pressure Wire Study

IVUS

www.cardiologyhd.com

Jan/Feb 2012 19


The Cath Lab Team First row: (L-R) Lisa Kostecka, Jacqueline Parry, Jacqui Tyzack , Sara Phillips, Darren Jordan 2nd row: Julie Mclea, Hristina Lacy-Hulbert, Emma Darke, Rebecca Saunders, Dr Tom Hyde, Dr William McCrea. 3rd row: Rachel Findlay, Stephanie Paul , Enrico Sibunga, Paul Frobisher, Francis Paran.

Cardiac Outpatients:

How many procedures are performed a year?

Echo

Stress Echo

TOE

Angiograms = 1330 PCI = 410 Pacemakers = 280

Holter Monitoring

Tilt Testing

12 Lead ECG’s

Pacemaker Checks

Cardiac CT

Types of equipment used? •

St Jude pressure wire

Boston iLab IVUS machine

Maquet IAPB

2 x Phillips IE33

1 x GE E9

1 x Vivid 7 Dimension 3D

1 x Vivid I

2 X GE Vscan

Have you had any new equipment installed recently? X-Ray Kit: Philips Allura FD10 x2 Physiological kit: Philips XIM (Xper Information Management) Archive: Xcelera Server for storing and viewing of our cardiac investigations. We went through a tender and evaluation process and it was felt that the Phillips kit best met our requirements.

20 Jan/Feb 2012 www.cardiologyhd.com

What is the approximate percentage of cath lab cases performed radially compared with femorally? 60% Radially 40 % Femorally Does your department offer a Primary Angioplasty Service? We do an 8-4.30pm PPCI service, we have been doing this for approximately 2 years, with very good door to balloon times. We have no current plans to go 24/7. One of the issues was how PPCI would interrupt the work when we only had 1 lab, which at times was a challenge, but throughout we maintained good DTB times. This has now been resolved with our expansion to 2 labs. What new procedures / techniques have you implemented into the department recently? We have started to do CRT-P and CRT-D in our labs. This has been a significant development for our department and patients, as they prefer to be treated locally. We are now using Bivalirudin for our PPCI. We have started doing day case PPM and PCI, this has played a key part in being able to reduce our length of stay and patients would rather go home. Stress echo service has been commenced.


What kind of training can new employees expect to receive? A period of being supernumery, they work towards a competency pack, in order to ensure staff are being trained in all areas and meeting standards required. What kinds of continuing education programs are available to staff? •

The critical care course

Teaching and Assessing course

Governance Study time monthly.

Industry Study days.

How do you deal with late finishing of cases? For example staggered working hours or just staff overtime? We allocate staff to stay late just in case we run over, this is then taken as time owing. What is you policy for company reps within the labs? We only book 1 rep per day to avoid any competitive companies, this is for education and for new products. All nice food donations are gratefully received! What is the best part of working at your facility? Working with a professional team, in a new environment which creates a happy working atmosphere. We receive very positive feedback from patients and have a low turn over of staff.

Above: Sister Jacqueline Parry What are the benefits to patients attending your facility? We offer a complete range of cardiac services which are delivered in a timely manner to meet all expected targets. Our recovery environment is new, light and airy with windows along one side. The patients will be dealt with by a friendly professional in a respectful way. We do have same sex bays to enhance the patients privacy and dignity while they are with us. How is your inventory managed? Currently we use barcodes when logging items during a procedure, and a spread sheet logging system for ordering and cross checking stock.

Below (from left): Jacqui Tyzack (Nurse), Lisa Kostecka (Nurse) and Dr William McCrea performing a coronary angiogram

How does the lab handle haemostasis? •

TR Bands for Radials

Digital pressure/ Angioseals for Femorals

We have Femstops also available.

What measures has the department implemented to cut costs? As a department we are part of the South west regional tender which has helped us save money. Also having stock on a consignment basis has been cost effective. Changing some procedures to day cases has also help reduce length of stay which saves money, this has also helped improve patient experience as it means patients are back at home more quickly.

www.cardiologyhd.com Jan/Feb 2012  21


Management

Assistance Management: Managing Expectations A.S.A.P. Ms Sophie Blackman Coronary Heart Management and CRM Consulting Editor Head of Clinical Cardiac Physiology West Hertfordshire NHS Trust

C

omplaints from staff and patients tend to always have the common underlying cause - an individual has an expectation that has not been met. Expectations have a direct link to behaviour and performance outcomes and are therefore a hugely important part of our business. As a manager you have the expectations of your staff to manage as well as that of your patients – just as your team must meet your patients expectations too. Understanding expectations is key to a successful business and it is helpful for you to address them ASAP.

AWARENESS STANDARDS ACKNOWLEDGEMENT POINTERS Awareness: In order to be able to meet expectations you must know what these expectations are. This seems very obvious but either as an employee or a manager you have to know what someone expects of you for you to have the opportunity achieve it. In fact this is true in all manners of life. Friends and loved ones can become upset with you when you don’t meet their expectations too but, so often, we find people hold expectations of us that we are not even aware of. It is unfair to set people up to fail because you have not let them know what is expected of them. It is important you invest in finding out what people’s expectations of you are, but also you should let people know what expectations you have of them. It is the discrepancy between the expectation someone has of you, and their assumption that you know what should be delivered that breeds disappointment.

allows time for questions or concerns to be raised. You shouldn’t agree to things you cannot deliver, unless you are able to negotiate on the variables – remember that standards should never be negotiable. Failing to meet an expectation that you had no possibility of ever meeting is still a failure. It is your job to let your manager know if the expectations they set are unreasonable for the task in hand. Acknowledgement: When there is a discrepancy between the expectation of the service user and those delivering it then the best thing is to acknowledge this mismatch. Whether it is regarding the manager and staff or the patients and the service it is only by acknowledging the difference in expectations can you work towards the common goal of delivering what is anticipated. Pointers: Regularly reminding people of your expectations of them and equally by regularly reminding people of what it is you can deliver ensures that everyone is on the same page. Good communication is vital. As a manager you can hold regular meetings or deliver mail-shots to your team, you can make sure your letters to patients are informed. As a staff member you must communicate how you are progressing with a task and make suggestions that you think can help you to meet the expectations of your patients, and as a manager you must make sure you actively listen and seek feedback. Ask your patients about their experience and what improvements they would like to see. After all, it is their treatment and their experience that should be at the core of your service. As a manager, when you do not meet the expectations of your staff it can cause disappointment that can cause disgruntlement and conflict in your team. You must put measures in place to learn your staffs expectations, such as through regular appraisals. As I said, understanding expectations is key to a successful business – but fundamentally the key to this is communication. You must not allow assumptions to take over and should address this ASAP.

Standards: Expectations should be set at the very start of any business transaction or relationship. Letting staff know what is expected of them or letting patients know what a particular test or procedure involves

22 Jan/Feb 2012 www.cardiologyhd.com

http://aimtobe.co.uk/professional/great-expectations-at-work/


United Kingdom

Events January 18

1

Optimising Cardiac Physiology Services Maple House Birmingham, England www.sbk-healthcare.com March 19 - 23

2

BCS & Mayo Clinic Cardiology Review Course Royal College of Physicians London, England www.bcs.com March 29 - 30

3

18th Annual Transoesophageal Echocardiography Course St. Georgeâ&#x20AC;&#x2122;s Hospital London, England www.toe-courses.com April 27

4 5

BCS: Research in Cardiology Royal College of Physicians London, England www.bcs.com May 28 - 30

1

6

5 3

2 7

BCS Annual Conference Manchester Central Manchester, England www.bcs.com September 23 - 26

4

6

HRC 2012 The ICC Birmingham, England www.heartrhythmcongress.com October 15 - 17

MORE ONLINE

7

Cases, Controversies & Updates 2012 Royal College of Physicians London, England www.bcs.com

To have your event listed see page 3 for contact details.

www.cardiologyhd.com

Jan/Feb 2012 23


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© 2011 McKesson Corporation and/or one of its subsidiaries. All rights reserved. Horizon Cardiology is a trademark of McKesson Corporation and/or one of its subsidiaries.

CardiologyHD #34  
CardiologyHD #34  

CardiologyHD - Coronary Heart magazine Edition 34

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