July / August 200
coronaryheart.com Latest News A New Class of Stent The CATANIAâ„˘ Coronary Stent System
Interview Dr Jamil Mayet (Chief of Service, Cardiovascular Medicine, Imperial College Healthcare NHS Trust)
Special Feature Mobile Cath Labs (UK and USA Case Studies)
Hot Topic Clopidogrel (Opinion from Dr Nick Curzen)
CRM Education Atrial Fibrillation & Cardiac Resynchronisation Therapy
NT E M
Distal Embolisation in Saphenous Vein Graft Intervention
Dr Chris Baker during Hammersmith Hospital Site Visit
(Sponsored by BIOTRONIK)
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U LT R A S O U N D
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Table of Contents July / August 2008 THIS EDITION 04
Cardiac CT: Benefit or Risk to Cardiovascular Programs
‘Dr Jamil Mayet’
Hot Topic ‘Clopidogrel’
Management ‘Finger on the Pulse’
14 16 1 22
Special Feature ‘InHealth Providing Leading Mobile Service to the UK’
Readers Comments from Edition 12
ECG Quiz Answer
Events Diary & Employment
Next Issue and Advertiser’s Index
Special Feature ‘Saint John’s Health System Mobile Cath Lab Integration’
Contrast Media ‘Contrast-Induced Nephropathy’
CRM Education ‘AF & Cardiac Resynchronisation Therapy’
Hammersmith Hospital Site Visit Page: 26
Site Visit ‘Hammersmith Hospital’
The New CATANIA™ Coronary Stent System
‘Distal Embolisation in SVG Intervention - (Part 1)’
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From the Editor Competition Winners at BCS
W Coronary Heart Publishing Ltd 145 - 157 St John Street London, EC1V 4PY United Kingdom
Dr Simon Redwood Chief Clinical Editor
Email: firstname.lastname@example.org Phone: +44 (0) 207 788 7967 Fax: +44 (0) 207 160 9334
The winner of the iPod Mr Tim Larner Director / Chief Editor Nano, from over one hundred entries, was Mrs Maggie Fearby, a Research Nurse from St Georges University of London. Although she wasn’t present to receive the prize, she was still able to forward a photo when the iPod arrived through her door.
Visit us online at
www.coronaryheart.com Dr Richard Edwards Asst. Clinical Editor
Director / Chief Editor Tim Larner
The other winner of the £25 Gift Card was won by Dr Fozia Ahmed, an SpR working at The Royal Preston Hospital near Manchester. We would like to thank all attendees whom took the time to stop by our stand to meet either Wendy Rose, our Media Sales Representative, or myself. Your comments of support were truly appreciated by both of us, and many provided us additional ideas on articles that we hope to include later in the year or for 2009.
Clinical Editor Dr Simon Redwood Senior Consulting Editors Dr Richard Edwards Dr Rodney Foale Dr Divaka Perera Mr Ian Wright Mr Stuart Allen Ms Voncile Hilson-Morrow
ith our first stand at the British Cardiology Society conference proving to be a resounding success, we are pleased to announce the winners of the iPod Nano and £25 iTunes Gift Card.
Dr Divaka Perera Asst. Clinical Editor
ADVERTISING Wendy Rose Rose Media Ltd Email: email@example.com
CIRCULATION 3536 Cardiac Professionals
Copyright 2006 by Coronary Heart Publishing Ltd. All rights reserved. Material may only be reproduced by prior arrangement and with due acknowledgment of Coronary Heart Publishing. The publication of an advertisement or product review does not imply that a product is recommended by Coronary Heart Publishing Ltd.
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Mr Ian Wright EP Editor Above: iPod Nano Winner Mrs Maggie Fearby
Mr Stuart Allen CRM Editor
Above: £2 Gift Card Winner Coronary Heart’s Director, Tim Larner (left) presenting Dr Fozia Ahmed with the £25 iTunes Gift Card
Coronary Heart should never be regarded as an authoritative peer reviewed medical journal. Coronary Heart 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.
What’s New? Taunton and Somerset Hospital Adds Second Lab
aunton and Somerset Hospital recently underwent a major refurbishment of their cardiology department in a bid to improve patient waiting times and level of care. Extra beds as well as a second cardiac lab containing a Siemens AXIOM Artis dFC imaging system were all part of the overhaul. The design was based around scalability with the addition of the Siemens AXIOM Sensis, a popular haemodynamic and electrophysiology recording platform. Other equipment included the Medcon Image Management System as well as TOMCAT to assist with data management and investigation scheduling. Gillian Stapleton, Lead Cardiac Radiographer for Taunton and Somerset Hospital said, “Maintaining high standards of patient care and treatment are of paramount impor-
(Left-Right) Marc Rose, formerly X ray Product Manager, Siemens; Dr David Beacock, Consultant Cardiologist, Cath Lab Lead; Diane Cooper, Cath Lab Manager; Dr MacIver, Consultant Cardiologist; Gillian Stapleton-Smith, Lead Cardiac Radiographer; Dr Pete Cavanagh, Acting CEO and Consultant Radiologist; Steve Holmes, National Sales Manager, Siemens. tance to us. The Siemens equipment is making a real difference. The enhanced image quality allows quicker diagnosis and faster treatment, ultimately lowering waiting times
and saving lives. The equipment is designed to keep the patient comfortable at all times during an otherwise stressful scan.”
Alder Hey Installs Biplane Flat Detector System
he Royal Liverpool Children’s NHS Trust, Alder Hey has recently installed a biplane flat detector angiocardiography system from Siemens. The new Siemens Artis zee will be used for general interventional radiology, cardiac and neurological investigations and therapy. The adaptable system permits examinations at any gantry position whilst ensuring that images are always angled for the best possible visibility. Floor mounted and ceiling mounted C-arms give the radiographer the optimum level of freedom in which to work, including a second isocentric working position that permits free head access to the patient or anaesthesia equipment. “We selected the Artis zee because it allowed us the flexibility to carry out general interventional work, cardiology and neurology, in the tiniest babies to young adults,” said Dr. Andrew Healey, Consultant Paediatric Interventional Radiologist at Alder Hey Hospital.
Left to right: Dr. Andrew Healey, Consultant Paediatric Interventional Radiologist, Nurses; Lesley Spellman, Sergey Bratukhin and Margaret Gleave; Irene Abbott, Operating Department Assistant, Lilian Taylor, Radiographer
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A New Class of Stent: The Stealth Surface Solution “Any intelligent fool can make things bigger, more complex, and more violent. It takes a touch of genius and a lot of courage -- to move in the opposite direction.” - Albert Einstein
ercutaneous treatments for cardiovascular disease have steadily advanced since 1977 when Andreas Gruentzig performed the first successful transluminal coronary angioplasty on a human. Since then, various improvements have been made that attempt to address the “Achilles Heel” of stenting: restenosis. •
More engineered reduction in strut thickness and surface contact.
Others sought to reduce vessel wall injury by improving balloon design.
Some improved stent geometry to increase flexibility and reduce vessel injury
Some used heparin coatings to reduce restenosis.
A few tried brachytherapy which has since been all but abandoned.
Some tried different substrates such as tantalum and cobalt chromium
Drug-eluting stents took center stage using polymer base coats, top coats, and matrices, mechanical divots, dimples, and channels to hold and elute the anti-proliferative drugs.
Many experimented with cell designs e.g., open, closed, sinusoidal
Original drugs were followed by their analogs.
Some researchers now say the future is bioabsorbable stents.
Others say it is adding more surface molecules such as endothelial progenitor cells or nitric oxide.
In the Southern United States, where CeloNova BioSciences is headquartered, this is called “putting lipstick on a pig.” These approaches focus on reducing or treating damage caused by the stenting procedure. However, the underlying problem of foreign body response remains. Incremental improvements have been made in almost every area of stenting except the most basic one: preventing the body’s own inflammatory response.
Above: The CATANIA™ Stent architecture
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Current thinking in the medical community is focused on “treating” complications. This paradigm lead researchers toward in-
Advertorial from CeloNova Biosciences
creasingly more complex solutions such as adding drugs, and more recently, biological agents to reduce negative outcomes associated with stent implantation. What if there was a simple solution that interrupted this cycle or prevented it entirely? CeloNova BioSciences’ patented, bioinvisible stent surface treatment with Polyzene®-F enables the body to accept the implant by permitting healthy cellular growth without activation of the blood coagulation cascade or the complement system.
All images courtesy of CeloNova BioSciences, Inc.
CeloNova approaches medicine from the perspective of prevention of negative outcomes rather than adding treatments to address side effects and complications. The Polyzene®-F surface treatment simply makes the stent “invisible” to the body. This concept of cloaking the stent surface has never been adequately explored and perfected until now.
The CATANIA™ Coronary Stent System with NanoThin Polyzene®-F is a new class of stent. It does not release drugs or biological agents. It allows for quick vessel healing. Therefore, the CATANIA™ stent does not require long-term dual-antiplatelet therapy. It is anti-inflammatory, bacterial-resistant, and helps to prevent tissue reactions that lead to restenosis. Importantly, the CATANIA™ stent has a 0% thrombosis rate in clinical studies performed to date. The CAT™, as it is called, is not a bare metal stent because it has a nanothin layer of Polyzene®-F. It is not a drug-eluting stent and does not contain any cytostatic, cytotoxic, anti-inflammatory, anti-thrombogenic drugs or additives. It is a well-designed, cobalt-chromium alloy stent with thin struts and a 40 nanometer-thin surface treatment of Polyzene®-F. A proprietary surface technology from CeloNova BioSciences, Polyzene®F is an ultrapure, inorganic polymer that bestows biocompatible, anti-thrombogenic, bacterial-resistant, and anti-inflammatory properties to any device or substrate it coats. The body ‘perceives’ the Polyzene®-F coated implant as being a natural, integral part of itself. All of these features combine to create what some physicians call “the safest stent” on the market. The CATANIA™ Coronary Stent System from CeloNova BioSciences proves that there are simple, elegant solutions to complex problems if you have the courage to move, as Einstein suggested, in the opposite direction. *The CATANIA™ Coronary Stent System with NanoThin Polyzene®F is CE Marked and available throughout the British Isles and all of the European Union. Contact sales@celonova. com or visit www. celonova.com for more information.*
Above: Nanothin Polyzene®-F surface treatment on the CATANIA™ stent
Biosense Webster Release New Catheter
atients in the European Union (EU) with arrhythmias, can now benefit from treatment with a new state-of-the art catheter. Called the EZ STEER™ THERMOCOOL® BiDirectional Catheter, the manufacturers Biosense Webster claim to reduce char and thrombus formation during ablation and give physicians improved range of motion during procedures The product uses a unique bi-directional catheter with an open irrigation tip which reduces the risk of coagulum and char from high-temperature ablation.
CE Mark for New Scoreﬂex Balloon
arlier last month, OrbusNeich announced they had received the CE mark for their new Scoreflex Balloon. OrbusNeich claims the new balloon is used in focused force angioplasty, a technique in which the force resulting from balloon inflation in a stenotic lesion is concentrated at one or more locations within the stenosis. The Scoreflex uses a dual wire system to create a focal stress pattern to facilitate effective controlled plaque fracture at low-resolution pressure. It also has a low crossing profile and great trackability.
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Hemel’s Expanded Use of ACIST
he cath lab at Hemel Hempstead Hospital will soon be moving to a larger new interventional centre at Watford and will expand their use of the ACIST Contrast Management System (see image right). The ACIST system works by providing a variable-rate adjustment of contrast media flow and volume. Clinicians are able to control the rate and flow of contrast injected into a patient simply by adjusting the pressure applied to the responsive hand controller buttons. Mary Kelly, Superintendent Radiographer at Hemel Hempstead Hospital, said: “After I familiarised myself with the system, I found the ACIST reliable, efficient and easy to use.” Find more on how an ACIST can help your lab by contacting APC Cardiovascular: Email: firstname.lastname@example.org
COOK Release New BM Stent
n mid June, COOK Medical’s cardiology unit, Global Therapeutics, received the CE Mark for their new cobalt chromium bare metal coronary stent called the Global Therapeutics GTX® Coronary Stent System. Joe Horn, president of Global Therapeutics stated, “the GTX stent has been engineered specifically to eliminate the technical challenges, such as recoil, stent balloon retention and stent spring-back, that have been associated with earlier cobalt chromium stent designs currently on the market.” Global Therapeutics is also in the process of developing a drug eluting stent using the GTX platform, with trials expected to begin in Europe in the third quarter of 2008.
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Above: The ACIST Contrast Management System
New Percutaneous Covered Stent Implanted in UK
TGI Medical Ltd has recently achieved the CE Mark in Europe, for their Over and Under® Pericardium Covered Stent (PCS). Designed for use in degenerated Saphenous Vein Graft stenoses (see Education p. 32), aneurysms, and perforations, the stent
First Implant of Voclosporin Coated Stent
trium Medical announced recently they had begun enrolment of the first patients for their CONFIRM 1, First-inMan drug eluting coronary stent clinical trial. The trial will initially enrol 100 patients through seven hospitals in Belgium with the primary endpoint of the trial to evaluate the safety and performance of the
is 100% covered with heterologous tissue. The first commercial implantation and first implantation in the UK was performed at the Royal Bournemouth Hospital, performed by the Cath Lab director Dr. Rosie Swallow
CINATRA™ voclosporin coated coronary stent system. According to Atrium Medical, the new stent system comprises an advanced cobalt chromium balloon expandable stent, mounted on a low profile rapid exchange catheter. Atrium’s stent and balloon are both coated with Atrium’s proprietary Omega 3 fatty acid coating technology, providing a more uniform bio-absorbable delivery vehicle for its anti-inflammatory compound, voclosporin.
CAUTION: Some products within this magazine may be restricted to specific regional usage, and may not be available in your region. Always check with the manufacturer to determine availability.
Siemens Launch ACUSON P50
n early May Siemens UK officially launched the ACUSON P50 portable ultrasound. You may have remembered we featured the P50 in Issue 10 (Jan/Feb 2008) where we did a sideby-side comparison with other systems; however here is a quick run-down. The device weighs just 5 Kgs, runs as a Microsoft® Windows® application on an Apple MacBook Pro notebook and is an advanced portable ultrasound system. A sliding control panel provides users with all the usual ultrasound functions. Royal London Hospital, part of the Barts and London NHS Trust, has placed the first UK order for the ACUSON P50. For a detailed list of features visit the Siemens website at www.siemens.co.uk/p50
Provided by: Ian Wright, Technical Head EP, St Mary’s Hospital, London, UK
This is the ECG of a young man with a structurally normal heart, and no chest pain.
What is the likely diagnosis?
Answer: Page 31
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Interview: Dr Jamil Mayet MBChB, MD, MBA, FESC, FACC, FRCP Chief of Service, Cardiovascular Medicine, Imperial College Healthcare NHS Trust Consultant Cardiologist and Honorary Senior Lecturer, International Centre for Circulatory Health, St Mary’s Hospital, Imperial College Healthcare NHS Trust Why did you decide to become an Invasive Cardiologist? By accident really. My original background was in cardiovascular physiology and I was, and continue to be, very interested in ultrasound as a tool for understanding cardiovascular physiology. However, during my training I spent much of my time at St Mary’s Hospital, which had a big interventional programme. My supervisors Jim Shahi and Rodney Foale trained me and I enjoyed the invasive work and have continued to have invasive as well as non-invasive interests. I now investigate cardiovascular physiology in the catheter lab as well as the echo lab.
Where did you train? I was a medical student in Dundee and trained in general medicine there as a junior doctor. I had a great time and while working in the clinical pharmacology and cardiology departments I became interested in Cardiovascular Medicine and decided to specialise in this area. I moved to London to do research under the supervision of Jim Shahi, Simon Thom, Rodney Foale and Peter Sever and gained a lot of clinical experience during this research period. After completing
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my thesis I continued my clinical cardiology training at Hillingdon, the Brompton and St Mary’s. I was appointed to the Consultant Staff at St Mary’s in 2000 and of course, since our merger in 2007, we are now Imperial College Healthcare.
What are some of your career highlights? I really enjoy watching our young researchers and clinical trainees develop and mature. We have had some really excellent people coming through the department and I am now old enough to have seen people through from medical to consultant appointments. More recently we have developed an academic training set up in the unit and have a team of very talented young researchers who we have started to see blossom; I have great hopes that this group and their successors will become academic leaders in the future. It is also very satisfying looking back at service developments and comparing how things were a few years back with the current set up – lots more to do though.
What do you believe will be the biggest change in cardiology within the next 5-10 years? I think the biggest change that we will see in the cath lab will be a reduction in the number of diagnostic cases as non-invasive imaging, particularly coronary CT angiography improves with more percutaneous valve replacement work and PFO closures replacing these procedures.
What are your thoughts on cardiac CT? Do you use this imaging modality? At the present time coronary CT angiography is a good test for excluding significant coronary disease. However it doesn’t seem to be reliable for quantifying stenoses. The biggest current problem is the radiation exposure. A recent paper in JAMA tried to quantify this by age and sex. Because women have the radiation directed on their breasts and younger people have longer to live on average, the lifetime cancer risks are particularly high in these groups. For instance the estimate of the lifetime cancer risk from a single coronary CT scan in a 40 year old woman was abut 1 in 300; often these pa-
tients have symptoms intermittently and end up with more than one investigation over a few years. It seems difficult to justify tests with a high radiation dose such as CT coronary angiography or Technetium/Thallium scanning in young people, particularly when stress echocardiography can provide similar information without radiation. At the present time I use CT coronary angiography for selected patients with difficult vascular access or with grafts in whom routinely angiography hasn’t managed to answer all of the questions. However, as the quality continues to improve and radiation doses decrease I can see this test largely replacing diagnostic coronary angiography.
You are one of the few Cardiologists to have an MBA. With more Cardiologists being involved in the business side of department management has this given you an advantage? To provide the best healthcare for your patients means setting up the best systems of care. For the NHS and other Healthcare systems to succeed I think you need, not just medical engagement, but also leadership, in management. Many doctors and managers are realising this, and one of the key changes that was promised with the merger of Imperial College, St Mary’s, Hammersmith and Charing Cross to form Imperial College Healthcare Academic Health Sciences Centre was the empowerment of the medical staff in management decision making. Of course that also comes with the requirement of financial responsibility. I am not sure having studied for an MBA has added a huge amount to the everyday experience I have had in clinical management over the years, but it might have helped me get my clinical management job!
Dr Nick Curzen PhD FRCP FESC Consultant Cardiologist Wessex Cardiac Unit Southampton General Hospital
Has recent data changed your practice regarding the optimum loading dose and timing for the use of clopidogrel pre-PCI? Not really. I have been using a 600mg loading dose for 3-4 years and have used 12 months for DES for over 2 years. I have been involved in some research looking at the assessment of individual responses to clopidogrel using a novel technique called short TEG and it really makes a persuasive case for checking how someone responds to the load and maintenance dose when you see the variability in clotting!
There has been recent concern about late stent thrombosis. Has this data affected the duration of Clopidogrel you prescribe after DES?
priate in the sense that we know some patients are given standard doses of clopidogrel and are not responding to it, so I think it is common sense that we should use a near patient easy-to-use test to determine response and individualise therapy accordingly. Otherwise we are effectively committing a few hyporesponsive patients to stents on single antiplatelet therapy from the word go! I also think that the increasing evidence for a “rebound” effect after stopping clopidogrel is fascinating. However, the latest data with prasugrel so far suggest a much more uniform response to this drug with almost universal potency....... more data are awaited but I suppose this could render the question of heterogeneity of clopidogrel response as obsolete.
Do you agree that adequate Clopidogrel preloading removes the need for IIb/IIIa inhibitors. Discuss. Certainly the ISAR-REACT study makes a good case that there is little indication for IIbIIIa inhibitors in stable patients who have been adequately loaded with 600mg clopidogrel. By contrast, Isar-REACT 2 suggests continued benefit of IIbIIIa inhibitors in some patients with ACS even with 600mg clopidogrelperhaps especially the trop positive ones. The answer lies in a thoughtful assessment of the individual case.... but overall my use of IIbIIIa inhibitors has more than halved over the last 2-3 years.
The issue of ST has become focused on clopidogrel resistance. This is appro-
What are your hobbies and passions outside of work? I have two small children and spend as much time with my family as I can. Outside that, I love football and have followed Arsenal through my life. Next season……..
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Dr John Paisey Clinical Fellow in Electrophysiology John Radcliffe Hospital, Oxford
hat would you call a study of a technique that involves satisfyingly dipping in for some juicy titbits before the main event? The TAPAS trial investigators publish one year survival data of primary PCI patients randomised thrombus aspiration before stenting or conventional PCI. The aspiration group had a cardiac mortality of 3.6% vs. 6.7% in the conventional treated arm. Vlaar and others The Lancet 2008; 371:1915-1920
The long term patency of saphenous vein grafts has long been seen as the Achilles heel of coronary bypass surgery prompting searches for less convenient but potentially more durable options. Previous randomised data on the radial artery as a conduit have been disappointing (see esp Desai and others NEJM 2004) but workers from the Brompton apparently motivated by a belief that graft preparation and lesion selection were keys to success randomised individuals to vein or radial graft. Stress was made of including only angiographically unequivocal lesions and of graft prep with suprasystemic pressure and calcium blockers. Five year graft patency was 98.3% in Radials against 86.4% in saphenous veins. Collins and others, Circulation. 2008;117:28592864.
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Some people still seem to think there may be a more elegant way of getting plaque out of the lumen of coronary arteries than shoving it out the way with a metal mesh coated in thrombogenic anti cancer drugs. If they’re right it doesn’t look as though high dose Rosuvastatin is the answer. In a two year quantitative angiography study of minor coronary lesions despite achieving impressive lipid profile improvements stenoses were reduced from 37.3 to 36%: reported as statistically significant but of at best questionable clinical relevance. Of course plaques may have been stabilised but the study was not powered to detect endpoints reflective of this. Ballantyne and others Circulation. 2008;117:24582466
Getting the runnyness of blood right for primary PCI is a tricky one as evidenced by the amount of research time and money expended. The Horizens –AMI trial looked at using Bivalarudin alone compared to Heparin and Abciximab, the intention being to compare bleeding risk and resultant outcomes. Although there was a slight increase in early stent thombosis overall 30 day mortality was significantly reduced, 2.1 vs. 3.1%
- Dr John Paisey scans the world’s cardiology journals
Early repolarisation is the latest sudden death syndrome to hit the cardiology headlines. In a study of sudden death survivors thought to have idiopathic arrhythmias it was present in 31% (vs. 5% controls). Furthermore the finding is associated with a doubling of recurrent arrhythmias vs. sudden death survivors without the feature. Haissaguerre and others N Eng J Med 358:20162023
What is the significance of a raised troponin in acute heart failure admissions? In patients admitted with exacerbations and no worse than moderate renal function positive troponin (I and/or T) was associated with both conventional harbingers of doom (low BP, low EF) but also independently predicted in hospital mortality. W Frank Peacock the Forth and others N Eng J Med 358:2117-2126
Stone and others N Eng J Med 358: 2218-2230.
On a related note the Finesse trial looked at the value of pretreating primary PCI patients with Abciximab with or without Reteplase as opposed to the usual in lab regime. It didn’t help. Ellis and others New Eng J Med 358:2205-2217
It always seems as though once things start going wrong with an ICD system the pain just keeps piling up. Some evidence of this phenomenon is provided by a follow up of high energy leads demonstrating a not too depressing 2.5% failure rate at five years. Unfortunately once a problem with a lead occurred the recurrent complication rate was 20%. This may have been partly related to a conservative initial strategy preserving functional modalities of the lead where possible and avoiding extraction. Eckstein and others Circulation. 2008;117:27272733
Congratulations Looks as though we have started something here after the last edition. As most of you are already aware, our Consulting Editor, Dr Rodney Foale became a father last year, proving you can never be too old to become a Dad. Amelia (definitely in the top two cutest babies we have seen) is now nine months old. We wish both parents all the best in the future.
Finger on the Pulse How far should we take cross-skilling in the Lab:
Greg Cruickshank Superintendent Radiographer Cardiac Catheter Suite King’s College Hospital NHS Trust. LONDON
n many ways my views on this were summed up in my comments in the last issue. Cross-skilling is helpful in smaller departments where lists could be cancelled if one team member was not available. I do not see a role for a generic worker in a tertiary referral centre where complex intervention work takes place, due to the added complexity of each of the team roles within that environment, and there is a fairly mobile workforce (for instance in London). Keeping staff fully competent across the range of skills required would be problematic, given the staff turnover most departments have. Evidence of a failure to keep fully competent would perhaps only manifest itself when the skills were needed most - that is in an acute/ emergency situation when things start to go wrong.
It is perhaps possible to overlap some skills to help develop a team approach without going down the fully generic route. Such overlap allows a team approach to Cath Lab working, without the risk attached to the generic worker option. How that shook out would depend on what resources and at what level of experience individual departments had at their disposal. Gold standard must surely be a Cardiac Technician, Radiographer, Scrub Nurse and Running Nurse in each lab. As to absolute minimum’s, ultimately it is the decision of the Cardiologist as to what he or she thinks is a safe minimum number. If it were me on the table as a patient, I would want at least a Cardiac Technician, Nurse, and Radiographer present, as well as the Cardiologist.
For readers comments to Greg’s last issue response see page 30.
Director / Chief Editor’s Blog: Anger Management
Mr Tim Larner Director/Chief Editor Coronary Heart Publishing Ltd
have worked in cath labs for around eight years and every so often you find that staff can lose their cool over the most trivial of incidents. This happened to me the other day, and for the first time since I have been in this industry actually
felt threatened and intimidated by the actions of an individual, a popular manager known for his non-threatening and nonintimidating behaviour. Believe it or not it was all to do with me returning a locker key to my ex-boss whom requested it that morning for a staff member whom had had personal items stolen from his bag.
I am guessing most of you have been a similar situation before. What initially seems to be trivial and a bit of a joke rapidly turns into a serious situation when the other party realise you are not taking them seriously. I have completed a course on Conflict Resolution but put in the situation with one of your colleagues, whom you normally joke along with and suddenly find yourself in a threatening situation is extremely difficult.
Lack of personal lockers for staff, in a locker room shared by two separate departments. Non-priority system. Full-time staff did not get priority over part-time or casual staff. Personal items were being stolen from those without lockers creating a strong demand for lockers.
The Situation: •
My old manager asked me to return my locker key which I hadn’t used for six months for a colleague whom had had belongings stolen.
continued on Page 39....
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InHealth Providing Leading Mobile Services Across the UK
nHealth is a leading provider of cardiac angiography and interventional cardiac services to the NHS as well as the largest provider of these services in the UK across both the public and private health care sectors.
West Suffolk Hospital NHS Trust When the West Suffolk Hospital NHS Trust needed to improve their already high levels of cardiac services whilst keeping costs low, they invested in the professional services of InHealth.
InHealth were chosen to provide the Trust with a high-quality mobile lab for twelve months which will be used once a week at Bury St Edmunds Hospital. Patients living in the area who would normally have to travel to the Papworth Hospital for treatment now have the chance to receive a diagnosis closer to home, greatly improving patient care. The lab is staffed by an experienced InHealth team, including a cardiologist, nurse and radiographer. The Trust is able to easily monitor the benefits of a cath lab for the future without sacrificing current services or over-stretching their own staff.
Royal Cornwall Hospitals NHS Trust This Trust recently contracted with InHealth to provide a relocatable lab for three to six months. Treliske Hospital in Truro, which was featured as a site visit in Edition 3 (Oct/Nov 2006) of Coronary Heart, recently commenced a refurbishment of one of its static labs and required a temporary lab throughout the build. Treliske Hospital’s new relocatable lab performs around ten patient examinations every day, utilising the Philips Integris Allura cardiac system. It is staffed by the hospital’s
An InHealth Mobile Cath Lab on-route to another site
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multi-disciplinary team of experienced radiographers, cardiac technicians and cardiac nurses. Most patients are elected admissions or are referred from the A&E department. Commenting on the new service, Tina Prestwood, Cardiac Cath Lab Manager at Treliske Hospital, said “We have been impressed with the very positive approach that InHealth staff have shown. We’ve enjoyed a fairly seamless transition to the new lab, thanks to their ‘can do’ attitude, and any difficulties that arose were dealt with immediately and efficiently”.
Mobile vs Relocatable Mobile cath labs are portable cardiac imaging systems transported within specially designed containers that feature expandable sides, covered patient lift systems and modern climate-controlled interiors. Mobile labs are useful for departments that are developing a new cardiac service and don’t have the capital or staffing requirements for a new installation. The labs provide an additional revenue stream and are also useful for expanding current services and reaching areas currently not served by cardiology facilities.
InHealth Mobile Lab for West Suffolk Hospital NHS Trust
Above: From L to R (back) are: Dr Ajit Agarwal (Consultant Cardiologist) and Jane Allen (Cardiac Unit Manager), and (front) Claire Kinett (Radiographer) and Gail Dempsey (Nurse).
Relocatable units are sophisticated angiography labs designed to be relocated quickly, usually requiring only two to three hours to set up on site. They’re the next step up from a mobile unit and, according to InHealth, are most cost-effective for institutions performing between 800 and 3,000 cases per year. This makes them ideal for sites that may be subject to phased construction, or where the cardiology unit may be moved or extended at some point in the future. Relocatable units are designed to maximise the procedural mix, including PTCAs, pacemaker procedures and EP/ablation procedures as well as diagnostic work. Like to know more about InHealth? Visit their website at www.inhealthgroup.com
InHealth Relocatable Lab for Royal Cornwall Hospitals NHS Trust
Above: L to R (front): Rachael Church (Senior Radiographer), Beverly Holmes (Staff Nurse), and Maria Forbes (Staff Nurse) (back row): Andy Secombe (Specialist Porter) and Rob Benton-Smith (Staff Nurse)
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Saint John’s Health System Mobile Cath Lab Integration
aint John’s Health System is a not-forprofit, Catholic hospital system based in Anderson, Indiana (located about 30 minutes Northeast of Indianapolis). The Cardiovascular Service Line at Saint John’s features a full array of diagnostic services, including a single diagnostic cath lab that was first introduced in 1995. The decision was made in early 2007 to update the current lab to better meet the demands of the patient population. The replacement lab was set to be installed in the location of the current lab and was going to require an estimated two months of total downtime from start to project completion. It was determined early in the process that it would be unacceptable to be without a cath lab for that extended length of time, because it would cause an unnecessary break in service and unnecessary travel expenses for patients. Over the summer months the hospital contacted several mobile cath lab vendors for price quotes and unit specifications. Indianapolis, Indiana – based Modular Devices Inc. was selected as a vendor based on price competitiveness, customer service, and proximity to Anderson. The interim mobile cath lab selected was a turnkey cath lab suite contained within a mobile unit – complete with an X-Ray imaging system much newer than our current equipment, a hemodynamic system, digital archiving system, contrast injector, and DICOM output to our in-house PACS system. Modular Devices was willing to assist Saint John’s in finding the best location the mobile cath lab. The hospital did not have a designated area for the mobile lab, so several different options were discussed and the vendor’s ex-
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pertise was extremely helpful. Eventually, a location outside a recently vacated Emergency Department ambulance bay was modified and prepared for the mobile unit. Saint John’s was able to use this space for a mobile CT lab as well as the mobile cath lab as the specifications of the mobile coaches were very similar. Saint John’s Engineering Department worked with Modular Devices to confirm the pad would meet the needs of the mobile cath lab for power, water, drainage, height, weight and accessibility. About six weeks prior to the mobile arrival, a Modular Devices representative came onsite to meet with Saint John’s Engineering, IT and Cardiology. At that meeting, the team confirmed the availability of data and phone lines prepared for interface issues with cath images and Cardiology-PACS system, and completed other logistical details. The hospital had the mobile unit delivered a few days before taking the current lab out of service. This gave the department time to transfer supplies onto the mobile lab, set-up the hemodynamic system to fit our current processes and documentation, and test all the equipment. Two applications engineers came with the lab to assist us with this transition and provided just-in-time training on all the equipment and systems with the mobile cath lab. They were present for the first few cases, until we were comfortable in our knowledge of the equipment and were additionally available the following week for further training and support. We found them to be knowledgeable and helpful and also very responsive to issues identified even after the initial training period had ended. Overall the implementation went very well;
SPECIAL FEATURE Written by: Ross Brodhead Director CQI and Cardiopulmonary Services Saint John’s Health System Anderson, IN 46016 765-646-8409 RRBRODHE@sjhsnet.org
Katy Barrot, RN, BS, CCRN Manager, Cardiovascular Services Saint John’s Health System Anderson, IN 46016 (765)-683-3109 email@example.com
all unexpected issues were minor in nature and quickly resolved. All of our planning and coordination with Modular Devices paid off and our goal of utilizing a mobile cath lab was realized. The first few cases were a success and were completed right on schedule. Saint John’s is set to unveil the new cath lab later this month. The entirety of the experience of utilizing a mobile cath lab unit as a bridge from the old lab to the new lab has been a positive one. It’s a significant monetary investment, but Saint John’s has found it to be an important and value-added strategic decision in order to maintain the continuity of care, as well as both patient and physician satisfaction during the renovation process.
Images courtesy Modular Devices, Inc.
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Contrast-Induced Nephropathy and how can you help protect your patients from it?
ne of the leading causes of renal failure for both in-patients and outpatients is contrast-induced nephropathy (CIN) following diagnostic and interventional procedures. As imaging modalities continue to evolve, more patients will be treated and diagnosed with contrast enhanced imagery. CIN varies from 5% to 38% depending on the patients risk factors. So in perspective, a lab performing 1000 plus cases a year puts almost 400 patients at risk for CIN. As cardiovascular professionals working in the lab we rarely see the latent effects of our patients once they leave, and their intervention is complete. So we are unlikely to ever see the renal damage that can occur 48 â€“ 72 hours following these cases. The only effects we may ever encounter would be a case with anaphylactic response, cardiac arrhythmia or arrest. What can we do to help decrease the incidence of CIN and preserve the renal function of our patients? CIN is defined as a 25% or greater increase in serum creatinine, or a decrease in calculated creatinine clearance in the appropriate clinical setting: exposure to intravenous or intra-arterial contrast, a rise in creatinine within 24-48 hours within contrast exposure, and the absence of other explanations for acute renal failure such as nephrotoxins, hypotension, and urinary obstruction. CIN occurs with much greater frequency and is more insidious, with effects that may not be visible. At this point it is believed that contrast agents stimulates vasoconstriction in the kidneys and decreases the kidneys ability to vasodilate. Some agents appear to cause ischemia by causing an increase of calcium ions into the renal vascular smooth-muscle cells. This in turn lowers the glomerular filtration rate (GFR). Contrast Medias are also known to irritate erythrocytes which increase blood viscosity reducing oxygen
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delivery. Because CIN takes several days to develop, patients might be discharged before any symptoms are evident. It should be taught on discharge that the patient be aware of any sings and symptoms and to contact their physician if they appear. Oral hydration is imperative and should be emphasized (provided that their overall health condition does not contraindicate increased fluid intake as in congestive heart failure). Patients should be instructed to watch for weight gain (>1kg or 2lbs per day), edema or if other signs appear the first days following their procedure. By the time symptoms of renal failure appear their renal function is decreased by as much as 75%.
Written by: Erik Benson RT (R) NorthBay Medical Center Heart and Vascular Lab Fairfield, CA
Some patients function will recover and could return to normal over time (unless additional contrast studies are needed). So it is clear that we not only need to be aware of the potential of CIN, but we must be prepared to reduce the likely hood of occurrence. Recognizing which of our patients are high risk and have the potential for contrast-induced acute renal failure is the key to improving our patient’s outcomes. There are many factors that may predispose a patient’s incidence of CIN. Pre-existing decreased renal function puts them in the high risk factor. The lower their function the higher their risk. We should as well be aware of any other comorbities, particularly diabetes and impaired cardiac function. Patients with diabetes and pre-existing renal insufficiency have the greatest risk of CIN. When patients in this group develop CIN they more than often develop oliguria as well. Screening for any contrast related problems would be the simplest approach. Check the blood urea nitrogen and creatinine levels prior to procedure to assure that they are within normal limits. Calculating the patients glomerular filtration rate (GFR) or creatinine clearance is another way to recognize any potential issues. The normal ranges of GFR, adjusted for body surface area, are: • •
Males: 70 ± 14 mL/min/m2 Females: 60 ± 10 mL/min/m2
Estimation using creatinine clearance In clinical practice, however, creatinine clearance is used to measure GFR. Creatinine is an endogenous molecule, synthesized in the body, which is freely filtered by the glomerulus (but also secreted by the renal tubules in very small amounts). Creatinine clearance is therefore a close approximation of the GFR. However, the approximation of the GFR calculation is best measured by the evaluation and visualization of the frequency and duration of urination. The GFR is typically recorded in units of volume per time, e.g. milliliters per minute (ml/min).
Example: A person has a plasma creatinine concentration of 0.01 mg/ml and in 1 hour he excretes 75 mg of creatinine in the urine. The GFR is calculated as M/P (where M is the mass of creatinine excreted per unit time and P is the plasma concentration of creatinine).
Modification of Diet in Renal Disease (MDRD) formula The most commonly used formula is the “4-variable MDRD” which estimates GFR using four variables: serum creatinine, age, race, and gender. The original MDRD used six variables with the additional variables being the blood urea nitrogen and albumin levels. The equations have been validated in patients with chronic kidney disease; however both versions underestimate the GFR in healthy patients with GFRs over 60 mL/ min. The equations have not been validated in acute renal failure (see figure 1). There was a presentation given at the CTO Summit this past year by Dr. Roxana Mehran in reference to CIN prevention, causes and treatments. A “scheme to define CIN risk” was introduced along with a scoring system that incorporated a series of risk factors predicting the potentional for CIN (see Figure 2). Prevention is key and should focus on limiting risk factors. Hydration is imperative to preventing CIN. The Cardiovascular Research Foundation Columbia University Medical Center conducted a trial comparing the efficacy of 0.9% Saline and 0.45% Sodium Chloride in 1383 patients to help determine an optimal hydration regimen. The study showed that 0.45% Sodium Chloride had an increased incidence by 2% where 0.9% Saline only had an increased incidence of less than 1%. In addition to hydration NAC (N-acetylcysteine) also proves to be very effective in the prevention of CIN. A prospective randomized study at Columbia University Medical Center took
83 high risk patients with a CrCl < 50 ml/ min gave them NAC 600 Bid X 2 days prior to 75ml of low osmolar contrast followed by hydration with 0.45% @ 1 ml/kg/h X 24 h. The end resulted in the control group (42) having a 21% increase incidence of CIN compared to a 2% increase in patients (41) that received NAC. A meta-analysis of 13 randomized placebo controlled trials showed that 4 of the 13 trials reported statistically significant reduction in CIN after NAC. Sodium Bicarbonate is also being used in conjunction with NAC helping to decrease the incidence of CIN. The REMEDIAL trial compared saline + NAC with Bicarbonate + NAC as well as Saline + AA + NAC. Out of 326 patients about a hundred in each group Bicarbonate + NAC showed only a 1.9% incidence in CrCl increase where saline + NAC resulted in 9.9% and saline + AA + NAC at 10.3%. Limiting the amount of contrast given to patients with reduced renal function has been the historical standard of care for angiography. The damage associated with contrast agents can be minimized also by using lower doses of contrast medium and by using low-osmolal or iso-osmolal nonionic contrast agents. Iso-osmolal nonionic agents have shown the lowest incidence of contrast-induced nephropathy. The type and amount of contrast agent is important. High osmolar, ionic agents were suggested to be highly nephrotoxic, whereas low-osmolar, non-ionic contrast agents where not. A meta-analysis of 39 studies found that patients with renal insufficiency had a reduced incidence of CIN when low-osmolar agents were used. No difference in CIN was noted in those with normal renal function. One recent study compared iodixanol (non-ionic dimmer, iso-osmolar) with iohexol (nonionic monomer, low osmolar) in patients with renal impairment and diabetes. This high risk group, iodixanol was associated with a significantly lower rate of CIN as compared with iohexol. Studies have found that a single agent in high risk patients un-
GFR = 186 x Serum Creatinine-¹.¹⁵⁴ x Age-⁰.²⁰³ x 1.21 if Black x 0.742 if Female Figure 1 CORONARY HEART ™ 19
Scheme to define CIN risk score Risk Factors
Contrast media volume
1 for each 100cc3
Serum creatine > 1.5mg/dl
Or 2 for 40-60 4 for 20-40
eGFR <60ml/min/1.73 m2
6 for <20 The total calculated score will give you the percentage of risk your patient faces.
Risk of CIN
Risk of Dialysis
6 to 10
11 to 16
Figure 2 dergoing cardiac catheterization or peripheral angiography suggest that both iodixanol and iopamidol may have a lower rate of CIN compared with iohexol. Additionally, the volume of contrast is important. There is a thought that the risk of CIN is proportional to the volume infused. There is a retrospective study (the tadros study) that investigated the association between the volume of iso-osmolar agents and CIN. In this study the mean dose of contrast (84.3 +/- 67 ml in 117 patients) was not associated with higher incidence of CIN. So the real question is, is the type of contrast agent important? Current evidence says that iso-osmolar contrast, in high risk patients reduces the incidences of CIN. An ongoing, prospective study (VALOR trial) may provide additional evidence in favor of iodixanol.
Eventually we may find that iodixanol will provide better outcomes for all patients with decreased renal function. Compared to lowosmolar, iodixanol needs to be studied for cost effectiveness. But the optimism that the Tadros study promises could defiantly improve the safety and improve the outcomes of our patients in the future.
2. 3. 4. 5. 6.
Solomon R. The role of osmolality in the incidence of contrast induced nephropathy: a systematic review of angiographic contrast media in high risk patients. Kidney Intl. 2005;68:22562263. Rudnick MR, Kesselheim A, Goldfarb S. Contrast-induced nephropathy: how it develops, how to prevent it. Cleve Clin J Med. 2006;73:75-80, 83-7. Stone GW, McCullough PA, Tumlin JA, et al. Fenoldopam mesylate for the prevention of contrast-induced nephropathy: A randomized controlled trial. JAMA 2003;290:2284–2291. Tadros GM, Malik JA, Manske CL. Iso-osmolar radio contrast iodixanol in patients with chronic kidney disease. J Invas Cardiol 2005;17:211–215.9 Rihal CS, Textor SC, Grill DE, et al. Incidence and prognostic importance of acute renal failure after percutaneous coronary intervention. Circulation 2002;105:2259–2264 Aspelin P, Aubry P, Fransson S-G, et al. Nephrotoxic effects in high-risk patients undergoing angiograSolomon R, Werner C, Mann D, D’Elia J, Silva P. Effects of saline, mannitol, and furosemide to prevent acute decreases in renal function induced by radiocontrast agents. N Engl J Med 1994;331:1416-1420phy. N Engl J Med 2003;348:491–499. Rich MW, Crecelius CA. Incidence, risk factors, and clinical course of acute renal insufficiency after cardiac catheterization in patients 70 years of age or older. A prospective study. Arch Intern Med 1990;150:1237-1242 McCullough PA, Wolyn R, Rocher LL, Levin RN, O’Neill WW. Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med 1997;103:368375 Caro JJ, Trindade E, McGregor M. The cost-effectiveness of replacing high-osmolality with low-osmolality contrast media. AJR Am J Roentgenol 1992;159:869-874 Cindy Kohtz, EdD, RN, CNE, and Maren Thompson, PharmD Preventing Contrast Medium Induced Nephropathy AJN September 2007 Vol. 107, No. 9
Abbreviated Prescribing Information – for full prescribing information, including side effects, precautions and contraindications, see Summary of Product Characteristics (SPC). Presentation: Aqueous sterile solution of iopamidol. Niopam 150, iopamidol 30.62% w/v (150mg iodine/ml); Niopam 200, 40.8% w/v (200mg I/ml): Niopam 300, 61.2% w/v (300mg I/ ml); Niopam 340, 69.4% w/v (340mg I/ml); Niopam 370, 75.5% w/v (370mg I/ml). Uses: X-ray contrast medium. Dosage and Administration: Do not exceed 250 ml. Myelography: Niopam 200, 5-15ml or 300, 5-10ml; Angiography and Arteriography: Niopam 300, 340 or 370, dosage according to procedure (see SPC); DSA Niopam 150, 340 or 370, dosage according to procedure; CT Niopam 200, 300 or 340, 40-100ml; IV urography: Niopam 300, 340 or 370, 40-80ml (up to 1.5ml/ kg); Arthrography: Niopam 300 or 340, 1-10ml. Children: according to procedure, body size and age (see SPC). Elderly: as for adults; use lowest effective dose. Contra-indications: Hypersensitivity to iodine. Do not immediately repeat myelography. Precautions and Warnings: Resuscitative measures should be available. Observe patients for at least one hour after treatment. Care in the elderly and patients with history of allergy, asthma, increased intracranial pressure, suspected intracranial tumour, abscess or haematoma, severe impairment of liver, kidneys or myocardium, chronic alcoholism, multiple sclerosis, Waldenströms macroglobulinaemia, myeloma, epilepsy, diabetes, pulmonary hypertension, hyperthyroidism, myasthenia gravis, Graves’ disease. Correct abnormalities of fluid and electrolytes, particularly in small children, babies and renal impairment. During cardiac procedures ventricular arrhythmias may frequently occur. Angiography: right heart insufficiency and pulmonary hypertension may precipitate bradycardia and systemic hypotension (ensure proper catheter placement). Sickle cell disease: iv injection may promote sickling in homozygotes. Phaeochromocytoma: iv administration may cause severe hypertensive crisis (premedicate with an alpha blocker). Avoid in homocystinuria, thromboangiitis obliterans or ascending infections with ischaemia. Possible interference with tests of thyroid function and for bilirubin, proteins, inorganic substances. To minimise risk of thromboembolism, avoid contact with blood in the syringe; flush catheters frequently. Do not mix with other drugs. Venography: caution in suspected phlebitis, serious ischaemia, local infections, complete venous occlusion. Urography: care in patients with impaired renal function. Check thyroid function in neonates after administration. Pregnancy and Lactation: If possible, use only during the pre-ovulation phase of the menstrual cycle; avoid during pregnancy. Only use during lactation if essential. Interactions: Vasopressors potentiate the neurological effect of intra-arterial contrast media. Papaverine: interaction may cause arterial thrombosis. Metformin: stop at the time of examination; reinstate after renal function is normal. Avoid neuroleptics, analgesics, anti-emetics, antihistamines, phenothiazine-type sedatives. Anticonvulsants should not be discontinued. Side Effects: Nausea, vomiting, erythema, heat sensation, fever, sweating, headache, rhinitis, laryngeal oedema, asthenia, dizziness, pallor, dyspnoea, hypotension, rash and blisters. Occasionally, anaphylaxis or other manifestations of allergy (may take up to several days to develop). Reactions involving cardiovascular system (vasodilatation with hypotension, tachycardia, dyspnoea, agitation, cyanosis, loss of consciousness). Infrequently, ventricular arrhythmias during intracardiac and/or coronary arteriography. Rarely, myocardial ischaemia, infarction, cardiac failure/arrest, Steven-Johnson syndrome, renal impairment, thrombocytopenia, asthma, pulmonary oedema, recurrence of hyperthyroidism in patients treated for Graves’ disease. After cerebral angiography: confusion, stupor, coma, paresis, (transient) cortical blindness, convulsions may occur. In myelography: rarely, seizures, transient confusion or transient motor or sensory dysfunction, meningism and meningitis (consider possibility of infection), headaches, dizziness, nausea, vomiting, pain in limbs, back or neck. Local pain and swelling at injection site may occur. Overdose: Support vital functions, maintain hydration. Iopamidol is haemodialyzable. Pharmaceutical Precautions: Protect from light. Discard if solution contains particulate or crystalline matter. Use immediately after opening. Discard unused solution. Avoid contact with metallic surfaces containing copper. Legal Category: POM. Authorisation Numbers: Niopam 150 PL 18920/0007; Niopam 200 PL 18920/0008; Niopam 300 PL 18920/0009; Niopam 340 PL 18920/0010; Niopam 370 PL 18920/0011. NHS list prices per single unit: Niopam 150 50ml vial £10.00; Niopam 200 50ml vial £12.00; Niopam 300 50 ml vial £18.00; Niopam 340 50ml vial £21.00; Niopam 370 50 ml vial £23.00. Full prescribing information is available on request from Bracco UK Ltd, Bracco House, Mercury Park, Wycombe Lane, Wooburn Green, High Wycombe, Bucks HP10 0HH, United Kingdom. Date of preparation: December 2007. Information about adverse event reporting can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Bracco on 01628 851500. BUK120703
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Radiology and Cardiology examinations in patients with chronic kidney disease: Two recent comparative studies
% Patients with increase in SCr 0.5 mg/dl
@>OBPqrav.Ìm^qfbkqp%@^oaf^`>kdfldo^mev^kaMbo`rq^kblrp@lolk^ovFkqbosbkqflkÌ Fkqo^*^oqbof^i^ajfkfpqo^qflk& Obpriqp7Fkqebqlq^ipqravmlmri^qflkqebobt^pklpq^qfpqf`^iafccbobk`bfkqebfk`fabk`b lc@FK%P@o¯-+2jd,aI&cliiltfkdKflm^j¤*^kaSfpfm^nrb¦*0/-
P = 0.39†
5 4.4% 0
Iopamidol-370 n = 204
Iodixanol 320 n = 210
% Patients with increase in SCr 25%
20 P = 0.44† 15 12.4% 10
Iopamidol-370 n = 204
Iodixanol 320 n = 210
FJM>@QPqrav/Ì.20m^qfbkqp%JA@Qbu^jfk^qflklcqebifsbolombofmebo^is^p`ri^qrobÌ Fkqo^sbklrp^ajfkfpqo^qflk& Obpriqp7Fkqebqlq^ipqravmlmri^qflkqebobt^pklpq^qfpqf`^iafccbobk`bfkqebfk`fabk`b lc@FK%P@o¯-+2jd,aI&cliiltfkdKflm^j¤*04-^kaSfpfm^nrb¦*0/% of patients
% of patients
2.6% Iodixanol-320 n = 76
0% Iopamidol-370 n = 77
4.0% Iodixanol-320 n = 76
'@FKabcfkba^p^k^_plirqbfk`ob^pb¯-+2jd,aIfkpborj`ob^qfkfkbcolj_^pbifkb^q 15*4/3elropmlpq`lkqo^pq m*s^irbfpklqpq^qfpqf`^iivpfdkfcf`^kq
Iopamidol-370 n = 77
This education article is proudly provided by
Atrial Fibrillation & Cardiac Resynchronisation Therapy – can technology help? A
If there is such a prevalence of CHF and AF sufferers, then it makes sense that a number of patients receiving Cardiac Resynchronisation Therapy (CRT) will also experience AF at some point after implantation of a device. This insinuates patients will continue to be at risk of an increased mortality, a decreased quality of life and further hospitalisations. The number is actually quite significant, in patients who are suitable for CRT, nearly 30% experience AF post implantation. If such a high number are going to experience AF, is there anyway we can help this patient group? It has been shown by large randomized trials that CRT therapy in itself can benefit these patient’s, the possible reasons for this include reduction in the degree of Mitral regurgitation, improvements in LV systolic function and remodelling of the atria and ventricles including many more. However, there is conflicting data to support this claim. The CARE-HF study demonstrated that the
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Figure 1: Kaplan-Meier estimate of time to first onset of AF 1.00
Freedom from AF in Survivors
trial Fibrillation (AF) and Congestive Heart Failure (CHF) are widespread cardiac disorders that are often concurrent. In fact, AF is found in 15 – 30% of patients with CHF, patients who experience these coexisting disorders also have a worse prognosis than CHF sufferers alone. Additionally, as patients New York Heart Association (NYHA) class increase, so does the prevalence of AF, from <10% in NHYA I to nearly 50% in NHYA IV sufferers. (1)
0.75 P = 0.79
CRT Group Medical Therapy Group
incidence of AF for patients treated with CRT (16%) was comparable to the patient group receiving optimal pharmacological therapy and no CRT therapy (14%).(2) Another large heart failure trial, COMPANION produced data to show the incidence of pre-implantation AF (17%) was contrasted with a post implantation incidence rate (16%). (3) Hoppe U.C et al reported from the CAREHF study that although CRT improved the patients outcome regardless of whether AF
developed, CRT did not reduce the incidence of AF from the evidence we have seen. (5) (Figure 1) A study by Kies. P et al reported that although CRT pacing resulted in significant clinical benefit and significant left atrial and left ventricular remodelling in 74 CRT patients with chronic AF, 93% of patients did not reverted to Sinus Rhythm. (4) It appears likely that up to 30% of CRT patients are going to experience AF and the
Figure 2 (via the coronary sinus) in response to an intrinsic complex sensed by the right ventricular lead. Additionally, in latest model devices, the triggering function can be employed to resynchronise on right ventricular Ectopy for those patients suffering from extra systoles. One possible scenario would be patients experiencing Ventricular Bigeminy where resynchronisation can be cut to 50%. The function can also be programmed to actually continue to trigger above the upper tracking rate to again produce 100% resynchronisation under all circumstances. (Figure 3). Often, AF goes undetected. Some data sources quote figures as high as 75% of atrial arrhythmias are asymptomatic. It is therefore advantageous for CRT devices to have advanced diagnostics for the identification and recording of AF episodes.
Ideally, the following data should be available: • • • •
associated added complications such as adverse hemodynamics changes, stroke, the loss of atrial contribution and the loss of AV synchrony at some point. Not only that, but persistent and permanent AF patients are unlikely to revert to Sinus Rhythm. (4) Is there a way that technology can help? The main goal of CRT is to establish Bi-ventricular pacing as near to 100% as possible to establish resynchronisation, this is normally achieved by programming an optimised, shortened AV delay that is less than the patients’ intrinsic PR interval (Figure 2). Under certain circumstances however, 100% Bi-ventricular pacing is unachievable, one such condition is if a patient is in fast AF. For those CRT patients that have not received AV node ablation, fast, irregular conduction through to the ventricle is a possibility. To manage such an issue one important function of CRT pacing is the ability to
“Trigger” on intrinsic complexes. The triggering function enables resynchronisation to occur by pacing the left ventricle
Atrial Burden (% per day) Mean ventricular rate during episodes Max. ventricular rate during episodes No of mode switching episodes per day Holter recording capability
Today, the majority of CRT devices available have many of the above mentioned capabilities. Whilst this proves to be a good
Figure 4: HD - IEGM of an atrial arrhythmia A RV mV
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Atrial Fibrillation & Cardiac Resynchronisation Therapy (cont...) Figure 5: Episode details Atrial Monitoring Episode General 6
Episode Type Detection
31-Aug-2006 17:53:05 38min 26sec
diagnostic aid there are limitations to there use. Generally, patients with CRT devices are followed up on a 3 or 6 monthly basis where their devices will be interrogated and the data is retrieved. However, what happens between follow up’s? How can we assess a patients’ atrial rhythm unless they report it. The answer is Home Monitoring. With the capability of early detection of AF and transmission of data the clinician can be informed of all the above stated information on a daily basis, or if they wish, as they happen on an event basis.
vides all the necessary data, this is obviously going to be beneficial in tailoring and optimising medication, possibly using internal cardio-version through the device to terminate an episode or planning patient care. References: 1.
Maisel W.H, Stevenson L.W – Atrial Fibrillation in Heart Failure. Epidemiology, pathophysiology and rationale for therapy. Am J Cardio 2003;91:2D8D
John G.F. Cleland, M.D., Jean-Claude Daubert, M.D., Erland Erdmann, M.D., Nick Freemantle, Ph.D., Daniel Gras, M.D., Lukas Kappenberger, M.D., and Luigi Tavazzi, M.D., for the Cardiac Resynchronization — Heart Failure (CARE-HF) Study Investigators. - The Effect of Cardiac Resynchronization on Morbidity and Mortality in Heart Failure. N Engl J Med 2005;352.
Michael R. Bristow, M.D., Leslie A. Saxon, M.D., John Boehmer, M.D.,Steven Krueger, M.D., David A. Kass, M.D., Teresa De Marco, M.D.,Peter Carson, M.D., Lorenzo DiCarlo, M.D., David DeMets, Ph.D.,Bill G. White, Ph.D., Dale W. DeVries, B.A., and Arthur M. Feldman, M.D., Ph.D.,for the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) InvestigatorsKies . – Cardiac Resynchronization Therapy with or without an Implantable Defibrillator in Advanced Chronic Heart Failure. N Engl J Med 2004;350:2140-50.
High definition IEGM’s of an atrial arrhythmia will be transmitted after detection containing marker channel, far-field, atrial, RV and LV electrogram for CRT devices. (Figure 4) The transmitted data will also contain information regarding episode type, initial detection, termination and episode duration. (Figure 5) From the data available it seems inevitable that at some point up to 30% of patients receiving CRT therapy will encounter Atrial Fibrillation, even for those patients accepting the relevant rhythm and rate control. If technology can help to deliver resynchronisation therapy under the majority of circumstances using the triggering functionality then this must be a prerequisite. If technology can help in identifying and informing the clinician of an atrial arrhythmia using a prompt, automatic method and pro24 CORONARY HEART ™
P et al. – Cardiac Resynchronisation Therapy in chronic atrial fibrillation: impact on left atrial size and reversal to sinus rhythm. Heart 2006;92:490-494
Uta C.Hoppe, Jaime M. Casares, Hans Eiskjaer, Arne Hagemann, John G.F. Cleland, Nick Freemantle and Erland Erdmann. – Effect of Cardiac Resynchronisation on the Incidence of Atrial Fibrillation in Patients with Severe Heart Failure. Circulation 2006;114:18-25
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with overviews of the newly amalgamated St Mary’s Hospital cardiology department
ADDRESS Cardiac Cath Lab Hammersmith Hospital Ducane Road, London W12 0HS United Kingdom
FAST FACTS •
All Toshiba imaging equipment including bi-plane. One radiographer for entire department. Over 000 diagnostic cases performed per year.
Cardiac Cath Lab Staff (Pictured from left to right): Denice Rouse (Cardiac Day-ward lead Nurse), Dr Chris Baker (Lead Interventional Consultant Cardiologist), Visiting Doctor from Charing Cross Hospital A&E Dept, Lina Tan (Cardiac Catheter Lab Nurse), Mario Lopez (Specialist Cardiac Physiologist), Dr Tito Kabir (Cardiology SpR - interventional), Kojo Kyereme (Specialist Cardiac Physiologist), Prince Zacharia (Specialist Cardiac Physiologist), Anita Champaneri (Superintendent Cardiac Radiographer), Rojimol Joseph (Cardiac Catheter Lab Nurse), Anna Kobus-Olamboda (Cardiac Catheter Lab Nurse), Maricris Tuason (Cardiac Catheter Lab Nurse).
The following questions have been answered by Mr Lee Lewis, Directorate Coordinator, Cardiovascular & Renal CPG, Imperial College Healthcare NHS Trust.
he Hammersmith Hospital is located in London and forms part of the Imperial College Healthcare NHS Trust, which combines other leading cardiology departments at St Mary’s and Charing Cross Hospitals. The department has just undergone a major update with all new Toshiba equipment, allowing the cardiology centre to continue providing leading cardiac care to their community.
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1. Size of hospital and department: Currently we have 3 dedicated interventional cardiac cath labs (2 with full EPS facilities) on the Hammersmith Hospital (DuCane Road, W12) site and the same on our St Mary’s (Praed Street, W2) site, so 6 in all. A dedicated 15-bedded Cardiac Day-
ward adjacent to the catheter labs on the Hammersmith site. Imperial College Healthcare NHS Trust - recently formed by the amalgamation of Hammersmith Hospitals NHS Trust and St Mary’s Hospital NHS Trust with Imperial College London School of Medicine to form the UK’s first Academic Health Sciences Centre - is situated on 4 sites in West London and is the biggest NHS Trust in the country, with 1,600 beds, around 10,000 staff, an annual turnover of more than £800m and over 1 million patient contacts per year.
2. Staff numbers: On the Hammersmith Hospital site our catheter labs are staffed by 9 interventional Consultant Cardiologists on a sessional rota, 8 Cardiology SpRs (also on rota), 10 Cardiac Nurses, 5 Cardiac Physiologists and a Superintendent Cardiac Radiographer. The modern state-of-the-art Toshiba x-ray equipment in all 3 labs is designed to be used by the operators and all the medical, nursing and cardiac physiology staff are trained both in its operation and are IR(ME)R trained and certificated. As a result we just have the single Supt. Radiographer whose prime responsibilities are patient and staff radiation safety, IR(ME)R regulatory affairs and the ongoing training of the medical, nursing and physiology staff, rather than traditional radiographic duties. This is not the case on our St Mary’s site, where we have 66 Radiographers working in the more traditional role of operating the catheter lab xray equipment.
3. Equipment: 3 x Toshiba Infinix x-ray systems (1 biplane) at Hammersmith Hospital site; 2 x Philips & 1 x Siemens (all monoplane) at St Mary’s Hospital site. Hammersmith Hospital Cardiac Catheter Labs are a reference site for Toshiba Medical Systems Limited. Bracco ACIST Contrast Injection system and Medrad high-pressure Contrast Injectors on both sites. Medcon digital moving-image archiving and management system with telemedicine links between the Trust sites and also with our main referring Trusts in the West London area (Ealing Hospital, West Middlesex University Hospital and Wycombe Hospital). Fysicon i-Connect Haemodynamic monitoring systems to all labs on Hammersmith site; Siemens Axiom Sensis systems to all labs on St Mary’s site. Bard EPS systems and St Jude En-Site EP navigation systems on both sites, plus Hansen EP Robot system and Biosense-
(Pictured from left to right): Mel McNeill (Specialist Cardiac Physiologist), and Kojo Kyereme (Specialist Cardiac Physiologist)
Webster Carto navigation system on St Mary’s site. Boston IVUS, Rotorblator & Filter Wires, Radi Pressure Wires & Analysers and Datascope Intra-aortic Balloon Pumps on both sites.
4. Day Procedures: Virtually all diagnostic coronary angiograms, a significant proportion of PCIs and straightforward pacemaker replacement procedures are performed as day-cases / daycase transfers (from / to referring DGHs). EPS and CRM device implants generally have an overnight stay the average overall stay for Primary Angioplasty patients is 3-4 days – most spend just 1 day at this Trust and transfer ‘back’ to their local DGH (to the A&E of which they would traditionally have been taken before the pPCI service was established) at 12 hours or as soon thereafter as possible.
5. Procedures performed per year: Our approximate annual activity levels across both sites are: Diagnostic Coronary Angiography PCI Right Heart Catheterisation EPS / Ablation PFO Closure ASD Closure Valvuloplasty
5,150 2,900 150 500 80 30 10
Total invasive / interventional procedures 8,820
Pacemaker Implants CRT PPM Implants ICD Implants ICD+CRT Implants Loop Recorder Implants
400 55 65 45 20
Total CRM device implants
CORONARY HEART ™ 27
HAMMERSMITH HOSPITAL (cont...) A&E, for an expert team led by an Interventional Consultant Cardiologist to perform an immediate coronary angioplasty (and stenting) procedure within 90 minutes of the initial onset of the AMI chest pain. We also provide a national (NSCAG) assessment service for patients with primary pulmonary hypertension at our Hammersmith Hospital site and at our St Mary’s Hospital site have the first robotic EPS system in routine clinical use, particularly useful for the ablation treatment of atrial fibrillation. Our percutaneous septal occlusion service has really taken off on both sites during the past 18 months.
8. Inventory Management: A combination of databases and manual systems at present, but moving to a totally electronic system as rapidly as possible.
9. Haemostasis Management: Traditionally, with manual pressure, in routine elective circumstances and for patients undergoing procedures involving overnight stay; by using arterial puncture sealing devices for day-cases and day-case transfer patients (St Jude Angio-Seal & Abbott Vascular StarClose).
10. Measures implemented to cut costs in the lab: (Pictured from left to right): Visiting Student Nurse from Charing Cross Hospital, and Prince Zacharia (Specialist Cardiac Physiologist)
6. Surgical Back-up:
7. New procedures implemented:
We have full cardiothoracic surgery services on both sites, but nowadays it is very rare that surgical back-up to PCI is called upon. Indeed, quite a number of patients with co-morbidities receive PCI having been designated not suitable for cardiac bypass surgery.
Not exactly recent, but for almost 5 we have been a national beacon site for 24/7/365 Primary Coronary Angioplasty services, whereby a patient having an acute MI out in the community is brought by a special LAS paramedic critical care blue-light service directly to the cardiac catheter labs, bypassing
28 CORONARY HEART ™
Careful and detailed procurement negotiations for costly devices and implantable consumables (ICDs, pacemakers, coronary stents, septal occlusion devices, EPS navigation and ablation catheters) variably either within consortia or independently, depending on which gives us the best value. Pre-purchase bulk deals to obtain substantial discounts. OJEU tendering for all other major-use invasive, interventional and EP consumables. Full bottom-up costings of procedures and comparison to HRG income received. Careful monitoring of coronary stent and ICD usage in line with NICE guidelines.
11. Alliances with other hospitals for the treatment of patients: As detailed in question 1, Hammersmith, St Mary’s, Charing Cross, Queen Charlottes & Chelsea and Western Eye Hospitals are now all in a single Trust – Imperial College Healthcare NHS Trust. We work closely with our main referring DGHs – Ealing Hospital, West Middlesex University Hospital and Wycombe & Stoke Mandeville Hospitals.
12. Training for new employees: Full induction and orientation for qualified and experienced new staff joining us. (No staff can join the out-of-hours on-call rota until they have worked in the catheter labs [during normal working hours, when everyone else is available] for at least 2-3 months). Trainee staff joining us are given full in-service training in line / parallel with the relevant stage of the particular academic course they are undertaking.
13. Continuing education programs for staff: Specialist short courses, appropriate MSc courses (part-time) or professional courses (BPEG / NASPE, BSE, etc.), company/ product-specific courses, in-house training in specialised techniques, operating the catheter lab x-ray equipment, IR(ME)R course, ILS / ALS, etc.
14. Competency checks for staff: After a due period of orientation and/or training (dependent on entry level) and experience in the labs all (new) staff are competency assessed by the Lead Clinician and Superintendent Radiographer together with either the Principal Cardiac Physiologist or the Head Nurse, whichever is appropriate. This assessment has to be passed before the individual can join the on-call rota, and even then each staff member new to the on-call service ‘shadows’ an experienced staff
(Pictured from left to right): Dr Chris Baker (Lead Interventional Consultant Cardiologist), and Lina Tan (Cardiac Catheter Lab Nurse)
member of the same profession for at least 2 months before being eligible to become independently on-call.
15. Challenges: Building an additional catheter lab on each site and then refitting the existing labs (over the past 18 months) whilst still maintaining our full contractual activity commitment! Getting everyone on board to set up the 24/7/365 Primary Angioplasty service and then running and maintaining it at the highest standards as it has grown, without additional staff or funding. We are now just 3 months into facing the challenge of integrating and amalgamating our services across our sites into a single unified service.
16. Department Management structure: In a state of redevelopment at present (see response to Question 15). The new Academic Health Science Centre (AHSC) Trust is organised into 6 Clinical Programme Groups. This department is in the Cardiovascular & Renal CPG, which has a Medical Director, a Head of Operations and a Head of Nursing in place currently, plus Chiefs-of-Service for Cardiology, Renal Medicine & Surgery, Cardiothoracic Surgery and Vascular Surgery (‘Phase 1’). We have just completed ‘Phase 2’ when a General Manager for Cardiovascular services has been appointed to complement the GM for Renal services who was already in post. Next in ‘Phase 3’ Lead Clinicians, Service Managers, Lead Nurses, Ops Managers and other senior staff will be appointed.
CORONARY HEART ™ 29
HAMMERSMITH HOSPITAL (cont...) 17. Dealing with late finishing of cases?
18. Policy for company reps within the labs?
19. What is the best part of working at your facility?
Presently there is an informal arrangement that one lab on each site remains open beyond normal hours to complete the day’s activities. We are keen to negotiate with staff to formalise this by either a staggered shift pattern or a change in staff working pattern (such as to 4 long days per week) or any other preferred algorithm that is proposed by the staff concerned which will work in practice to satisfy the needs of both staff and management.
We have a written policy which is communicated to all suppliers and their (new) reps and a strict booking system operated by the Head Nurse, whilst in order to be eligible for a lab slot to be booked any company rep has to have been invited to attend the labs by a Consultant Cardiologist or other senior clinician (Head Nurse, Principal Cardiac Physiologist, Superintendent Cardiac Radiographer, etc.).
The team is like a family, the catheter labs are spacious, bright and airy, the equipment is all new and state-of-the-art, the Cardiac Day-ward is next-door to the labs, so everything tends to flow reasonably smoothly and people are happy to work here.
Reader Comments from Edition 12 RELEVANCE IS KEY
safety risk without first looking at solutions or suitable alternatives. It is important for Mr Cruickshank to be forthright with his staff and their need for CPD in relation to available funding and departmental requirements. In general terms, he can always consider secondment of position which will allow adequate staff numbers, a safe working environment and ultimately a more competent and flexible staff.
Mr Mo Sankoh Lead cardiac radiographer Essex Cardiothoracic Centre, Basildon
Please allow me to comment on Mr Cruickshank’s contribution to Management – Multi-skilling in the Cath Lab in your May/June 2008 edition. I agree with him that there is a safety issue to consider if staff members are moved around the catheter labs in the name of training. His projection of a 5% risk to quality of care and safety attributed to generic training is arbitrary and could even be greater. It would however take the inconsiderate manager to ignore staff training due to perceived ‘’5%’’
30 CORONARY HEART ™
Candidates opting for the generic worker course (or other form of training) should be selected from those deemed well motivated and able. There should also be post training support for candidates to improve on their confidence and ability. It is worth noting that even professionals working in their separate disciplines can only perform the duties they are comfortable with. This is important if departmental safety for patients and staff is not to be compromised. Mr Cruickshank also mentioned training opportunities, among others, as requirements for staff recruitment and retention. I will point to the need for him to embrace relevant training for his staff. The alternative is either no training at all or the offer of
some obscure one-day course (there are lots to pick from) with the latter providing very little in the way of relevance but the mandatory free sandwich and a day off work. In the catheter lab setting, the generic course is one of the most relevant training your staff can undertake. Ellie Gorman, one of your contributors (same article/issue) is a generic worker and highlighted her positive views of this course. Ms Gorman pointed to her ability to assist both physiologists and radiographers, thus contributing to the smooth running of her department. This course or other relevant training is about acquiring the necessary skills mix which will enable staff to fulfil both their departmental role and career potential. Finally, Mr Cruickshank seems to think that the generic worker is best suited to smaller centres that undertake diagnostic work only. Paul Smyth, who also contributed to the discussion on this issue, however holds an opposite view. He recommends the generic worker for the larger departments. I will suggest that decisions about training should be based on the need to empower your staff with useful knowledge. The decision to do so (and considering financial constraints) must be seen as a positive contribution towards service improvement.
ECG Quiz Answer
See original question on page 9
his ECG shows a broad complex tachycardia with right bundle branch block (RBBB) appearance. This could represent supra ventricular tachycardia with rate related RBBB/aberrancy or could be ventricular tachycardia (VT). The appearance of clearly identifiable “dissociated” p waves (labelled “p”) seals the diagnosis as VT. In fact the p wave morphology is negative in the inferior leads, which is not consistent with normal sinus activation - the p waves are likely the result of poor V- A conduction with variable degrees of block rather than dissociated sinus rhythm. As this is a young patient with a structurally normal heart this is an example of idiopathic VT. The presence of RBBB suggests a left ventricular (LV) origin. A common form of idiopathic LV VT is fascicular tachycardia. In fascicular VT the QRS is relatively narrow because ventricular activation is initi-
ated from within part of the His Purkinjii System – from one of the fascicles of the left bundle, in this case the posterior fascicle. Functionally the LBBB is divided into left anterior and left posterior fascicles. It is failure of conduction in one or other of these fascicles that results in hemi block on the surface ECG. The QRS is quite narrow for VT, being in the order of 140 ms and a diagnosis of fascicular VT was confirmed at EP study.
tachycardia (re-entry occurring between fascicles) whilst in others the tachycardia appears focal due to triggered automaticity. It is more common in men than women.
VT arising from the posterior fascicle has a RBBB morphology with left axis deviation (LAD) and a superior axis. This is the more common form of fascicular tachycardia, as in this example. Tachycardia arising from the anterior fascicle also has a RBBB morphology but with right axis deviation (RAD).
Fascicular VT is sometimes misdiagnosed as SVT with rate-related bundle branch block, particularly where there is one to one V-A conduction. In this example the lack of one to one association of QRS and p waves facilitates the diagnosis of VT.
The mechanism of this arrhythmia is variable – some patients meet criteria for a re-entrant
© Ian Wright 2008
Ablation of fascicular tachycardia from the posterior fascicle is usually achieved via a retrograde approach at a location at the junction between septum and the inferior/posterior left ventricle, often approximately two thirds of the distance from base to apex.
CORONARY HEART ™ 31
Distal Embolisation in Saphenous Vein Graft Intervention Pathophysiology, Prevention and Treatment Strategies: Part 1 of a 2 Part Series
By Charlene Shellenberger, BS, RN Clinical Education Specialist Healthworks, Inc.
ver 400,000 coronary artery bypass graft (CABG) procedures are performed in the US every year,1 and nearly all of them incorporate saphenous vein grafts (SVG) as aortocoronary conduits. In the first year after bypass surgery, however, 10 to 25% of these vein grafts fail. By 10 years post-surgery, 40 to 50% of grafts are closed, and half of those that remain patent have significant obstructive disease. In contrast, left internal mammary arterial (LIMA) grafts are frequently patent and disease-free 20 years post-surgery.2 Why is there such a difference in the longevity of SVG vs. LIMA grafts? For the answer, let’s go back to the basics of anatomy and physiology of veins and arteries. Although both vessels are composed of three layers – the intima, media and adventitia --
32 CORONARY HEART ™
the medial layer is much thicker in arteries. Remember that form follows function: the muscular medial portion of the arterial wall must accommodate the high systemic pressures generated by the left ventricle, with an average mean arterial pressure of 80-100 mm Hg. The thick medial layer also helps propel blood through the body. In contrast, veins are thin-walled and designed to operate in a low-pressure system. They’re twenty times more distensible than arteries, and the highest pressure to which they’re exposed is 18-20 mm Hg at the level of the venuole, dropping to 4-5 mm Hg as blood returns to the right atrium.3 Veins also have valves to prevent the backflow of blood, and they rely on large muscle con-
traction and the respiratory pump to assist in venous return. When a vein is attached to the aorta and anastomosed to the native coronary artery, we’ve in effect taken something designed for a low-pressure system and attached it to a high-pressure system. Soon after implantation and exposure to this systemic pressure, SVGs undergo intensive intimal hyperplasia, followed by accelerated and progressive atherosclerosis. Vein graft atherosclerosis (VGA) is usually not recognized before two to three years after CABG and doesn’t appear to cause measurable graft attrition before five years postop. The increase in vein graft attrition seen
Figure 1: Differences between Vein Graft Atherosclerosis (VGA) and Native Artery Atherosclerosis VGA lesions
Native artery lesions
Found throughout the length of the graft
Extremely friable and prone to embolization May progress over time to eccentric and severe stenosis
more than five years post-surgery, however, appears to be in large part due to VGA, and the presence of late stenosis in vein grafts is a predictor of adverse clinical outcomes.4
While SVG intervention accounts for 10 to 15% of PCIs in most centers, it’s complicated by high procedural, in-hospital and longterm event rates. SVG patients also have a greater atherosclerotic burden compared to native vessel patients.
Vein-graft PCI has been plagued by three problems: •
distal embolization and the resultant phenomenon of slow flow/no reflow.
progressive graft disease outside the target lesion.
restenosis, or recurrence of stenosis after ballooning or stenting. Image courtesy Healthworks Inc.
And while the best option in this era of drug eluting stents (DES) may be stenting of the native coronary, for many of these more fragile patients the only acceptable strategy is treatment of the vein graft.
Image courtesy Healthworks Inc.
There are important differences between SVG vessel disease and native vessel disease (see Fig. 1). Compared to native vessel disease, SVG plaques have a poorly defined cap. They’re bulkier, more diffuse, more friable, and have larger amounts of underlying thrombus (see Fig 2&3).5 In addition, it’s thought that blood turbulence at the anastomosis site -- where the graft is sutured from the large aorta to a smaller coronary artery -- plays a role in SVG deterioration.6
Despite major advances in catheter-based therapy and adjunctive pharmacology, percutaneous revascularization of diseased SVGs remains a critical challenge for the interventional cardiologist and the cath lab team.
Options for the patient with severe graft disease include reoperation, percutaneous coronary intervention (PCI) of the native artery, and intervention of the SVG itself. Bypass redo, however, carries a three to five times higher risk of mortality (8 to10%) and is often reserved for patients without a LIMA graft and diffuse SVG disease. Unfortunately, many of these patients don’t have adequate distal targets or acceptable left ventricular (LV) function for bypass redo. They’re often advanced in age and have more co-morbidities than patients undergoing CABG for the first time.7
Figure 2: Autopsy view of SVG degeneration, or “clogged drainpipe.”
Figure 3: Cine view of ectatic, friable SVG degeneration.
CORONARY HEART ™ 33
DISTAL EMBOLISATION IN SVG INTERVENTION (cont...)
Distal microvascular spasm
Distal microvascular obstruction
Caused by release of potent Platelet microembolism. vasoconstrictors from platelets upon thrombus disruption.
Neutrophil activation and accumulation.
Thromboxane A2, Serotonin, Adenosine
Responds poorly to nitroglycerin (NTG).
Free radical generation.
Figure 4: Potential Pathophysiologies of the No Reflow Phenomenon
Historically, SVG intervention has been characterized by high rates of no reflow (10 to 15% of procedures), post-procedural MI (17 to 20% of procedures) secondary to embolic debris, and 30-day major adverse cardiac events (MACE) rates of 16.9%.8 SVG PCI patients also have a ten times higher incidence of in-hospital mortality.9
creased risk of myocardial infarction (MI), morbidity and mortality during and after the procedure (see Fig. 4&5). First described by Kloner and Jennings in 1974, slow flow/no reflow is defined as inad-
equate myocardial perfusion through a given segment of coronary circulation without angiographic evidence of mechanical vessel obstruction. Hong et al. observed that distal emboliza-
Because of the friability and non-encapsulated nature of SVG lesions, embolization of atherosclerotic debris is a major risk during PCI. It’s estimated that embolization occurs as much as 100% of the time, although angiographic evidence presents only 15 to 20% of the time because of the microscopic nature of much of the embolization.10 The effects of atheroembolization on the patient depend on the amount, size and composition of the atheroembolic debris as well as the patient’s left ventricular function and microcirculatory status.
The Slow Flow/No Reflow Phenomenon Slow flow/no reflow is among the most serious atheroembolic effects. Patients who experience this complication have an in-
34 CORONARY HEART ™
Figure 5: Slow flow/no reflow after SVG intervention. Photo courtesy of Chris Bounds, MD.
tion with associated slow flow/no reflow was an independent predictor of late mortality and in-hospital CK-MB elevation (>3-5X normal) in patients undergoing PCI for lesions in degenerated SVGs.11 The exact mechanism of slow flow/no reflow is not known but is thought to stem from dysfunction or obstruction of microcirculation at the level of the resistance arterioles. It may occur through spasms of distal microcirculation, platelet clumping and the distal embolization of pieces of friable lipid-rich plaque. The release of chemical mediators that may lead to constriction at the arteriole level has also been proposed as a mechanism of action.12
Embolic Protection Therapies In 2002, the Saphenous Vein Graft Angioplasty Free of Emboli Randomized (SAFER) trial transformed the standard of practice for SVG lesion intervention by demonstrating that PCI performed with embolic protection was associated with a lower incidence of no-reflow, peri-procedural MI and late adverse events. In addition, the SAFER trial showed a favorable cost-benefit profile.
The strategy behind distal occlusion is to block the vessel being treated several centimeters beyond the target lesion so that plaque liberated from the lesion during angioplasty or stent placement remains suspended in the resulting stagnant column of blood. If that column of blood and the debris it contains can be aspirated completely before distal occlusion is relieved and antegrade flow is restored, distal embolization of debris will be prevented.14 Mechanism of operation The distal occlusion device consists of a 0.014-inch hypotube on which an inflatable occlusion balloon is mounted. The balloon tip is passed across the lesion in its deflated state before angioplasty or stenting takes place, and the hypotube shaft is used as the interventional guidewire throughout the procedure.
Distal embolization of debris can be prevented if the stagnant column of blood and the debris it contains can be aspirated before flow is restored.14
Both small and large particles as well as soluble mediators can be trapped more completely than is the case with filters, which may allow some smaller particles and soluble mediators (thromboxane) to pass through.
Occlusion time should not exceed seven minutes, and patients may complain of chest discomfort during occlusion time. Distal occlusion devices can be technically challenging, requiring interventionalists and cath lab teams to be proficient with the systems for optimum results.
Several minutes of end-organ ischemia occur because of occlusion throughout the intervention.
There is limited contrast opacification of the target lesion during occlusion, which may make visualization for stent placement difficult.
Systemic embolization of very proximal lesions is possible.
Aspiration may fail to recover debris in stagnant pools near the fornices of the occlusion balloon or in the loosely adherent boundary layer near the stent surface.
Interventionalists aren’t always able to tailor guidewire choice to other procedural requirements.
Image courtesy Medtronic
The distal balloon is inflated before intervention. It remains inflated until a distal aspiration catheter (PercuSurge Export, Medtronic) has been used to aspirate or lavage the stagnant blood column and its suspended debris (see Fig 7). At this point the occlusion balloon is deflated, flow is restored and the protective device is removed.
Today there are many choices for embolic protection, with strategies falling into four broad categories: •
Benefits of distal occlusion include the following:
Image courtesy Dr. Joseph Cinderella
The trial compared SVG intervention using the Medtronic GuardWire® Distal Occlusive Device (see Fig. 6) to intervention using a standard guide wire. The results were impressive. Thirty-day MACE rates fell from 16.9 to 9.6%, and no reflow fell from 8.8 to 3.3%: a nearly 50% reduction in event rate.13 As a result, embolic protection for SVG intervention is now a Class 1 ACC/ AHA/ SCAI Practice Guideline and the recommended standard of care for SVG stenting.
Figure 6: Medtronic AVE GuardWire® Distal Occlusion Device
Figure 7: Clot aspirated with the Export catheter
CORONARY HEART ™ 35
DISTAL EMBOLISATION IN SVG INTERVENTION (cont...)
Medtronic AVE GuardWire Plus Temporary Occlusion and Aspiration System (Medtronic, Minneapolis, MN)
The Medtronic GuardWire System was the first distal protection system commercially available in the US and the device used in the SAFER trial.
Even if distal filters do allow smaller debris particles to pass through, experimental data by Mauri et al. suggest that embolic particles <100 microns are tolerated in far larger number than are larger particles before interfering with microcirculatory function. Smaller particles are also less likely to cause end-organ damage.16
Distal filters are technically less complex than distal occlusion devices and therefore easier to use.
Distal filters operate on the principle that a deployed filter can allow ongoing perfusion and yet trap some, if not all, particulate debris. Continual flow can be more comfortable for the patient, and the physician has better visualization of the treatment area.
Limitations include: •
Some patients requiring SVG stenting are not candidates for distal protection because of lesion location. In fact very distal lesions may preclude the use of any kind of distal protection device.
Mechanism of operation: Distal filters are advanced across the target lesion in their smaller collapsed state. The retaining sheath (the delivery catheter) is then withdrawn, allowing the filter to open and expand against the vessel wall. The filter remains in place to catch any liberated embolic material larger than the filter pore size (usually 100-120 microns) during intervention.
Embolic debris may be released during initial lesion crossing with bulky delivery catheters without protection in place.
Distal filters may become occluded before the intervention is complete.
Filters do not prevent the transit of soluble mediators into the myocardium that may lead to slow flow/no reflow.
At the end of the intervention, the filter is collapsed using a sheath (the recovery catheter) and the captured embolic material is removed from the body. Benefits of distal filters include the following: •
Athough distal filters might be expected to retrieve only larger particles, analysis shows nearly identical particle size distribution and aggregate volume of debris retrieved with either a distal filter (100 micron pore size) or a distal occlusion/aspiration system. A filter’s ability to trap particles far smaller than its nominal pore size may stem from the tendency of particles to clump or strand across filter pores, reducing the functional pore size.
36 CORONARY HEART ™
Image courtesy Boston Scientific Corporation
Device options for distal occlusion include:
Figure 8: Embolic debris captured by Filterwire Device
to 3.5 mm, and another for vessel diameters of 3.5 to 5.5 mm. (See Fig. 8) The 0.014 in. FilterWire device serves as a steerable interventional wire for the procedure and is available in lengths of 190 and 300 cm. The filter, which looks like a butterfly net, is a perforated polyurethane sheet (110 microns) attached to a nitinol loop. The nitinol conforms to the vessel shape and keeps the filter in place. The distal 3 cm of the wire allow the operator to shape the tip to aid in crossing the lesion.17 Here are some hints for working with the Filterwire device: •
Think black and white TV: the filter wire comes preloaded in a delivery catheter with a black tip. The recovery catheter has a white tip. A tear-away introducer sheath and torquer are also included in the kit.
Place the introducer sheath in the hemostatic valve and advance the Filterwire device as a unit, using the torquer to steer the tip past the lesion. Deploy the filter basket and remove the delivery catheter.
The basket should remain stationary and not drag along the inside of the vessel, which is counterproductive in preventing distal embolization. Because the filter basket wire is the interventional wire, any movement of the guidewire moves the basket up and down. Filter basket position and distal flow should be monitored frequently.
Device options Two distal embolic filter devices are currently approved by the US FDA for use in SVGs; • •
FilterWire EZ® System (Boston Scientific, Natick, MA) Spider™ Embolic Protection Device (eV3, Plymouth, MN)
Both devices consist of a delivery catheter, the filter device, and a retrieval catheter. Both allow contrast imaging during the procedure as distal perfusion is maintained.
FilterWire EZ® Embolic Protection System The FilterWire EZ System is available in two sizes: one for vessel diameters of 2.25
Image courtesy eV3 Inc.
delivered in a single hoop, with the capture wire/nitinol braid filter pre-loaded in the delivery end of the catheter.
Figure 9: SpiderFX™ Embolic Protection Device •
As the basket catches and fills with debris, distal perfusion may be diminished and the basket should be captured in the white tipped recovery sheath and removed. The FilterWire device is single-use only: do not attempt to rinse the basket and replace it back in the vessel.
Spider™ Distal Embolic Protection System The SpiderFX™ Embolic Protection Device consists of a capture wire and a dual-ended SpiderFX catheter. The device allows use of any 0.014 to 0.018 in. guidewire for initial lesion cross and delivery catheter placement. (See Fig. 9) The capture wire is a nitinol braid filter mounted on a 190 cm or convertible 320/190 cm PTFE-coated 0.014 in. stainless steel wire. The capture wire is available in a broad range of filter diameters from 3 mm to 7 mm. It acts as the primary guidewire for other interventional devices compatible with a 0.014 in. wire. The dual-ended SpiderFX catheter is used to exchange the primary access guidewire with the capture wire, deploy the capture wire at the desired location, and recover it at the end of the procedure. The delivery end of the catheter is green and has a crossing profile of 3.2 Fr. The recovery end is blue and has a crossing profile of 4.2 Fr. All components of the device are
A note of caution about distal protection strategies: It’s important to note that both distal occlusion and distal filter protection strategies have limitations based on SVG lesion location. Some patients requiring SVG stenting are not suited to distal protection devices because of lesion location, and very distal lesions may preclude the use of any kind of distal protection device. In addition, embolic debris may be released during initial lesion crossing with bulky delivery catheters without protection in place. Distal occlusion devices require several minutes of ischemia and must be placed and retrieved within seven minutes. Distal filters may become occluded before the intervention is complete, and filters do not prevent the transit of soluble mediators into the myocardium that may lead to slow flow/no reflow.
In Part II in the next issue of Coronary Heart we’ll investigate proximal occlusion and pharmacologic embolic protection.
www.medtronic.com Treatment: Distal Protection Systems. Why do saphenous vein grafts in the heart deteriorate? Are the forces the same as those causing deterioration in veins?
Fuster V, Alexander RW. Hurst’s The Heart. 11th Ed. 2004; Ch. 58: 1497.
de Feyter PJ. Percutaneous treatment of saphenous vein graft obstructions: A continuing obstinate problem. Circulation 2003; 107: 2284-2286.
Boston Scientific Corporation 2007. PowerPoint: Saphenous vein graft intervention.
10. Sugita J. CardioVascular Center, Frankfurt, Germany. PowerPoint: Embolic protection devices: what is available? 11. Hong MK, Popma JJ, Pichard AD et al. The clinical significance of distal embolization after transluminal extraction atherectomy in diffusely diseased saphenous vein grafts. Am Heart J 1994; 127: 1296-1303. 12. Salinas G, MD. UTMB Galveston, Department of Internal Medicine, Division of Cardiology. PowerPoint: No reflow phenomenon. 13. Baim DS, Wahr D, George B et al. Saphenous Vein Graft Angioplasty Free of Emboli Randomized (SAFER) Trial Investigators. Randomized trial of distal embolic protection device during percutaneous intervention of saphenous vein aorto-coronary bypass grafts. Circulation 2002; 105: 1285-1290. 14. www.medtronic.com Product Information: distal occlusion, GuardWire.
Hermiller, James MD. Commentary: Contemporary Management of Vein Graft Disease. Journal of Invasive Cardiology 2005; ISSN: 1042-3931: 17 (8): 399-400.
Fuster V, Alexander RW. Hurst’s The Heart 11th Ed. 2004; Ch 58: 1496.
Martini F. Fundamental of Anatomy & Physiology 7th Ed. Ch 20: 695.
Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 8th Ed. 2008: 492.
Schoenhagen P, Ziada K et al. Arterial remodeling and coronary artery disease: the concept of “dilated” versus “obstructive” coronary atherosclerosis. Jnl Am Coll Cardiol 2001; 38: 297-306.
15. Carrozza JP, Mumma M, Breall J et al. Randomized evaluation of the TriActiv balloon-protection flush and extraction system for the treatment of saphenous vein graft disease. J Am Coll Cardio 2005; 46: 1677-1683. 16. Mauri L, Rogers C, Baim DS. Devices for distal protection during percutaneous coronary revascularization. Circulation 2006; 113: 2651-2656. 17. www.bostonscientific.com FilterWire EZ™ Embolic Protection System.
CORONARY HEART ™ 37
EVENTS DIARY + RECRUITMENT
Diary July King’s Cardiology Live
10 - 11 July, 2008 King’s College Hospital Foundation NHS Trust, London, UK Web: www.cardiologyatkings.com
August ESC Congress 2008
30 August - 3 September, 2008 Munich, Germany Web: www.escardio.org
British Society of Echocardiography Annual General Meeting
Cardiology Therapeutics Conference 2008
3-4 October, 2008 Harrogate UK Web: www.bsecho.org
19 -20 September, 2008 London, UK Email: firstname.lastname@example.org
Heart Rhythm Congress 2008
19-22 October, 2008 Birmingham, UK Web: www.heartrhythmcongress.com
October 3rd Leeds Interventional Trainees Course
1 - 3 October, 2008 Leeds, UK Web: www.millbrookconferences.co.uk
Core Training in Echocardiography
6th International Meeting on Intensive Cardiac Care
25 - 27 October, 2008 Tel Aviv, Israel Web: www.isas.co.il/cardiac-care2009
2 October, 2008 Harrogate UK Email: email@example.com
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38 CORONARY HEART ™
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continued from page 13 •
Upon checking my locker to remove personal items I met the manager whom looks after “locker delegation” (aka. The Key Master). The Key Master demanded I give the key to him not my manager whom requested it.
Two Options: 1.
Give the key to the Key Master as requested and explain to my manager what happened. Main problem with this course of action is that it puts your manager in a difficult situation, and possibly can make them question your ability to carry out simple tasks (like returning a key). Return the key to my manager, and explain to the Key Master that the Manager requested it, so the issue can be taken up with them. The advantage of this course of action is that you have done what was asked of you, leaving the ongoing departmental locker issue to continue without your involvement.
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Cardiac MRI and PET
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Echo Case Study - Isolated Ventricular Noncompaction
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The Decision: I decided upon option 2, returning the key to my manager first.
The Result: The Key Master did not take to kindly to this decision and had a good rant about his dissolving position of power, and commenced a nice barrage of insults and threatening behaviour. When the Key Master turned red and was starting to tremble with anger I took a line out France’s history and quickly left the scene of the conflict. I heard afterwards that he was ready to hit me for not giving him the key.
Write for us Share your expertise with your fellow workers by contributing an article to Coronary Heart. All topics related to the cath lab are welcome. For more information and a copy of Coronary Heart’s author guidelines: email the Chief Editor Tim Larner at firstname.lastname@example.org
Final Outcome: I gave the key to my manager, however within minutes The Key Master had it in his hands by bypassing the usual chain of command, going straight to senior hospital management. One week later though it was returned to my manager afterall and given to the colleague whom originally asked for it.
ADVERTISERS’ INDEX 02
Next Issue: Tim’s Blog will look at the importance of being honest with yourself during a debriefing.
Anger Management: So we are left with this final thought. What would you recommend for the Key Master? I saw him a few days ago, shook hands, and accepted what I think was an apology. I quietly suggested that he should take Anger Management classes. Interestingly he laughed back at me. Turned out he was the lecturer for the hospital Anger Management classes. God help us all!!
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CORONARY HEART ™ 39
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