November / December 2007
coronaryheart.com Site Visits
• Inside The Mayo Clinic - EP Department • Lancaster General Hospital, PA
Special Feature Cath Lab Design
T N E
Technological Advances in Lesion Assessment
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November / December 2007
THIS EDITION 04
Special Feature ‘Building a Heart Center’
Contents Mayo Clinic Site Visit
Page: 20 Lancaster General Hospital Site Visit
Reader Submitted ‘Anti-Coagulation Clinic’s’
Cardiac Site Visit ‘Mayo Clinic EP Department, Rochester, MN’
Interview ‘Douglas Beinborn - Mayo Clinic’
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Education ‘Technological Advances in Lesion Assessment’
‘Lancaster General Hospital, PA’
24 - 2 32 - 39 48
Cardiac Site Visit
www.bracco.com Special Thanks
www.healthworksonline.cc CORONARY HEART ™ 3
From The Editor S Coronary Heart Publishing Ltd Independance Wharf 470 Atlantic Avenue, 4th floor Boston, MA 02210 United States Email: firstname.lastname@example.org Phone: +1 (617) 273-8012 Visit us online at www.coronaryheart.com Director / Chief Editor Tim Larner Clinical Editor Dr Rodney Foale Consulting Editors Dr Richard Edwards Ms Voncile Hilson-Morrow Mr Ian Wright Mr Stuart Allen
ADVERTISING Request Media Kits online CIRCULATION USA edition 8521 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.
eptember was the month I headed back to the United States for a fifteen state whirlwind tour starting at the New Cardiovascular Horizons conference in New Orleans. For those of you who managed to attend I am sure one of the highlights was the Mardi Gras parade at the conclusion, put on by the conference organizers. Somehow I was allowed to hop on one of the floats and throw beads at people on the street. What a great time!! Travelling from state to state as an outsider it is interesting to see the subtle differences in various communities. In Colorado there is a desire to have the largest vehicle on the road. In Massachusetts drivers throw the rule book out the window. In Illinois, Tennessee, and Kentucky the freeway doubles as a speedway. And finally New York is home to the fastest taxi drivers in the world (we hit 100mph up the Van Wyck Expressway).
Tim Larner Director
For most of my travels I managed to avoid the big cities as I travelled through Colorado, Utah, Wisconsin, Minnesota, and multiple other states passing through smaller towns. These places are what America is all about. A strong sense of community where people acknowledge you, wave, and even strike up a conversation. When I asked them about what they thought of their local hospital everybody seemed proud, and strangely knew several people who worked there. You see outside of the main cities people often refer to their hospital like it was a landmark. This landmark status doesn’t get any bigger than the Mayo Clinic (featured in this edition), located in the small city of Rochester in Minnesota. Although the Mayo buildings dominate the city, Rochester has remained very pleasant with friendly people not hesitating to talk with you or to offer a helping hand. This is also true with the Lancaster General Hospital in Pennsylvania (also in this edition). It is a major reason we love doing site visits outside of the main cities. Departments are usually smaller, and the staff are extremely proud of what they have achieved. Several readers from larger facilities have written to us stating they appreciate seeing how smaller departments operate as they often have different challenges to solve. If you are a smaller department and would like to be featured in this magazine then please don’t hesitate to contact us. We are sure you will enjoy the current edition, and as always if you have any questions or comments you can email me directly at email@example.com. I would love to hear from you.
- Tim Larner COVER PHOTO: The Gonda Building at the Mayo Clinic, Rochester, MN.
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.
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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.
What’s New? GORE HELEX Septal Occluder Approved for ASD’s
n early October W. L. Gore & Associates announced they had gained FDA approval to market their the GORE HELEX Septal Occluder with modified catheter delivery system. The indications for this device are for the transcatheter closure of atrial septal defect (ASD). Interventional cardiologists can use the device in the cath lab as it is designed for deployment via standard femoral venous access. The device is composed of ePTFE patch material supported by a single nitinol wire frame that bridges and eventually occludes the septal
Cardiac Science Releases New System
defect to stop the shunting of blood between the atria.
resulting in successful closure of the defect.
Over the course of several weeks to months, cells begin to infiltrate and grow over the ePTFE membrane,
Visit www.goremedical.com/helex for more information.
Six Month Results for Triton SideBranch Stent™
was used in conjunction with a standard drug eluting stent to treat 30 patients with coronary blockages involving large side-branches. After 6 months, none of the patients suffered from side-branch restenosis.
couple of issues ago we mentioned the Triton Medical Side-Branch Stent and showed you a diagram of how it worked. Now though the six month results are in from the first in-man study.
ardiac Science Corporation have recently launched the Quinton Q-Tel RMS(R) 3.0. The Q-Tel 3.0 improves workflow efficiency with enhanced connectivity, allowing the rehab department to connect to the hospital’s HIS and EMR system. This was in response to customer requests.
The results were presented by Dr. Ralf Müller (Helios Heart Center, Siegburg, Germany) and Professor Patrick W.J.C. Serruys (Erasmus Medical Center, Rotterdam, the Netherlands) at the European Bifurcation Club Meeting in Valencia, Spain.
Visit www.cardiacscience.com for more information
The Tryton Side-Branch Stent™
Triton reported that the core laboratory quantitative analysis reported a late loss of 0.27 ± 0.42 mm in the side branch and 0.12 ± 0.47 mm in the main vessel. “The Core Angiographic Data demonstrates that the hybrid approach, bare metal Tryton SideBranch Stent used in conjunction with a standard drug eluting stent, provides the same type of restenosis reduction we have seen when drug eluding stents are used to treat standard lesions,” said Professor Serruys, Erasmus Medical Center, the Netherlands. “This is the first time, I have seen such promising results in the treatment of bifurcation disease,” added Serruys. CORONARY HEART ™
What’s New? Hansen Sensei™ Continues International Growth
ince receiving both FDA and CE Mark clearance in May 2007, Hansen Medical have installed a total of five Sensei™ Robotic Catheter systems in the United States and four in Europe. The installation sites include large teaching sites through to community hospitals because physicians of differing skill level are able to successfully employ this remote catheter navigation system within their practices. As a bonus for Europe is the ability to provide robotic control of irrigated ablation catheter technology for atrial fibrillation. Hansen stated recently that “The combination of the Sensei system’s ability to accurately position catheters at targeted cardiac anatomy along with the more effective lesions created by irrigated catheters should have a powerful effect on procedure outcomes.
Stereotaxis Niobe 93% Success Rate
ata given at the recent European Society of Cardiology Congress (ESC) in Vienna reported a 93% acute success rate in patients treated for atrial fibrillation (AF) with the Niobe® magnetic navigation system. Dr Xu Chen, M.D., of the Rigshospitalet at the University of Copenhagen presented the findings from 42 patients with AF from which in 93% of these cases the pulmonary veins were fully isolated from the left atrium, eliminating the main cause of the arrhythmia. Each case took on average slightly less than 2 1/2 hours as Dr Chen guided the catheters with the Niobe magnetic navigation system, controlled from his remote station adjacent to the procedure room. The average exposure time was less than ten minutes.
“We have performed more than 250 total cases with the Stereotaxis system,” said Dr. Chen. “The ESC presentation was based on our first series of complex ablations and since then we have performed an additional 68 complex cases. We have had zero complications, and fluoro time in the last 50 cases has dropped to five minutes per procedure. Procedures with the Stereotaxis system are faster and far more precise than I could perform with my hands. We are incredibly happy with the system’s performance.” Stereotaxis is though not only used for EP, but it is proving very useful for interventional procedures as well. At the recent TCT meeting in Washington DC, Stereotaxis utilized a Mobile Vascular Lab to perform demonstrations to show its simplicity. And with 2000 PCI’s already performed internationally, it is good to see that with such a high initial outlay it can be used in multiple procedures. Visit www.stereotaxis.com for more information
At present Hansen Medical has two centers of excellence - The Cleveland Clinic, in Cleveland, Ohio, and St. Mary’s Hospital in London. Visit www.hansenmedical.com for more information Image courtesy Stereotaxis
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What’s New? Sonosite Releases New Ultrasound: The M-Turbo
ith possibly the coolest name in the imaging industry, Sonosite has just released their latest creation: The M-Turbo. As you would expect with a name like that the processing speed has been thrown into overdrive with a 16-fold increase which the company says ‘generates dramatic improvements in image quality by simultaneously running multiple advanced algorithms.’ An example of this is SonoADAPT™ Tissue Optimization which automatically adjusts imaging parameters depending
on the exam type, making it easier for any cardiologist to not worry about too many buttons to push. The M-Turbo also offers seamless connectivity for digital image export in a rugged, hand-carried product weighing less than 8 pounds.
World’s Smallest Ultrasound
iemens have recently released a new ultrasound called the Acuson P10. This hand-held device is designed for complementary initial diagnostic care and triage, particularly in cardiology. It’s main advantage is portability because it weighs only 700grams and is barely larger than a Blackberry.
Image courtesy Siemens Image courtesy Sonosite
Compiled by: Mr Stuart Allen, Technical Head CRM, Southampton General Hospital, UK
atient was admitted for a non cardiac surgical procedure and reported occasional palpitations. A pacemaker check was requested as a result of this ECG. Patient has a dual chamber pacemaker (implanted 18thms ago). Last pacemaker check 6 months ago was normal. For the answer please visit www.coronaryheart.com and click on Education CORONARY HEART ™ 7
Cardiology in the Future Stem Cell Advances
The cellular units are cultured for a month to obtain sufficient numbers of cells for transplantation.
Where there is no electrical activity, this corresponds with an area of myocardial infarction.
ardiologists from the University Hospital of Navarre and the Gregorio Marañón Hospital in Madrid have commenced clinical trials (Phase II) on fifty patients in order to test the efficacy of adult stem sell transplants within the hearts of patients whom have suffered a myocardial infarction and have ventricular dysfunction.
The cells are injected in and around the damaged areas of cardiac muscle using a special injection catheter.
The catheter that is used to inject the stem cells is made up of a very fine needle retractable at its end. The catheter is placed via the femoral artery and once in the left ventricle between 15 and 20 injections of myoblasts are placed. The procedure normally takes between three to four hours to complete.
The difference from other studies is the implantation of the cells is via a catheter rather than the traditional open heart approach. The technique is as follows: • Extraction of myoblast cells via a biopsy of muscular tissue from the leg of the patient.
So how do the Cardiologists know where to inject the stem cells?
Researchers isolate the adult stem cells.
XTENT Results Very Promising
One of the major requirements of this trial has been to ensure no other invasive techniques are used on the patients to give more accurate results.
They use a navigation system known as non-fluoroscopic electroanatomical mapping (CARTO System). This technique is commonly used in EP whereby a three-dimensional reconstruction of the left ventricle provides information relating to the electrical activity anatomically.
Custom II: is a 100-patient study designed to evaluate the safety and efficacy of Custom NX for the treatment of long and multiple lesions. Going for one year.
TENT, Inc announced followup data from their CUSTOM I and CUSTOM II single-arm prospective studies evaluating the safety and efficacy of its Custom NX® drug-eluting stent.
The results for both trials showed no new major adverse cardiac events (MACE), and the incidence of late stent thrombosis for patients treated with the Custom NX was zero percent.
Custom I: is a 30-patient first-inman study designed to evaluate the preliminary safety and feasibility of in-situ stent customization. Going for two years.
Commercialization of the Custom NX is expected to commence in Europe in late 2008.
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Data from XTENT Inc, as reported at TCT 2008 in Washington, DC.
The aim of the trial is to see if this new treatment is effective and to improve on the cardiac function of patients who have suffered a heart attack.
OBITUARY Dr Henry Marriott 1917 - 2007 “World-renowned cardiologist” Dr Henry “Barney” Marriott has passed away at the age of 90. He will be best remembered for his work in the field of ECG interpretation in which he wrote a number of books. He will also be remembered for his entertaining lectures that always drew an interested crowd. At age 13 he moved to England from Bermuda where he later attended Oxford University. In London he had the opportunity to work under Sir Alexander Fleming in the penicillin research unit, and in 1946 moved to the USA where he worked at Johns Hopkins Hospital and the University of Maryland. In 1962 he moved to Florida. Marriott passed away August 31, 2007 in Riverview, FL.
Online Forums EP Lab Forum: epicardial mapping ablation equipment veitch57 wrote: An embarrassingly simple question. What types of needles are around for epicardial work. Yes i know we can use good old cook needles for pericardial taps etc but i am interested in what is around for epicardial access in the cathlab. thanx Respond online
Management Forum: Inventory Management TheBoss wrote:
Cardiac Nursing Forum: Contrast allergy - what do you do? veitch57 wrote: I guess we usually aim for steroids and antihistamines. Some go for the night before for steroids if possible. Hmm there is debate about using Omnipaque or Visipaque. Some say either. Both have iodine in them of course so i suspect no difference, I must ask around to see what is the best. Respond online
With the high demand on cath labs today, streamlining services to maximise productivity is a priority. To achieve this many labs have installed state of the art inventory management systems. Please tell us the systems you use, or why maybe you have chosen to avoid this new technology for the time being? Respond online
Radiography (RT) Forum: Equipment ferretpants wrote: I am interested to know what Cardiac cath lab x-ray equipment people are using? Are you happy with it and why/why not? Respond online
Cath Lab Forum: D2B rnaden1 wrote: Hi Cath Lab friends, I am looking for info on door to balloon times for pts and staff. If you established d2b, what are your protocols. I have read that some hospitals have done d2b, but stopped. Thanks Roberta Respond online
Peripheral Vascular Forum: Acute stroke patients in the cath lab winky0107 wrote: Was wondering if any other cath labs are bringing in acute stroke patients? A group of our cardiologists (and one neurosurgeon) is putting together a “Code Stroke” protocol to bring in these patients. I know of angio departments in radiology doing this, but the argument here is that the staff in radiology cannot handle the acuity of these patients (!). I unfortunately don’t have many details yet, but am concerned about training all the on-call staff to perform competently in these procedures. As it stands now, we have a core group of only 12-15 people who assist with the carotid stenting. Any advice/suggestions/comments would be greatly appreciated. Respond online
For these and many more questions visit our FORUMS page on the website at www.coronaryheart.com It is free to browse, free to login, and free to post. Join our international community now!! CORONARY HEART ™ 9
Building A Hea Ce A facility dedicated to heart care and surgery, as well as outstanding patient outcomes and experiences.
- By Elizabeth Clark, Clinical Director, Cardiovascular Services, The University of Kansas Hospital
any people build a new home. When they do so, they decide what is important to them and what makes them comfortable. Design generally takes into account what the person or family enjoys or how time is spent. Many questions abound: How many bedrooms? How should we plan the living spaces? What about the kitchen, patio, den and so on? At The University of Kansas Hospital, we followed the same process in building the Center for Advanced Heart Care, a facility dedicated to heart care and heart surgery. The process of designing and building any structure typically involves working with consultants, architects and construction teams. What made our project different were the careful consideration of each patient area and how they work together, as well as a focus on staff satisfaction and retention, patient comforts, and convenience and caring for both groups.
Only the Beginning First, the process to determine the right size for the Center for Advanced Heart Care began. A consultant helped determine what would be best for our 10 CORONARY HEART ™
organization and our program. Our Business and Strategic Development Department worked carefully to determine capacity projections for both the inpatient and outpatient areas, including the cardiovascular (CV) labs and cardiovascular operating rooms (CVORs). The architectural firm RTKL, of Dallas, Texas, was chosen through a request for proposal process, as was the nationally recognized, local construction company J.E. Dunn. Owner’s Representative Services, Inc. joined the team to provide construction project management, and the design process was well on its way.
Thoughtful and Functional Design Right away, the hospital’s clinical and administrative teams had to ask themselves: What is most important for our heart center and our heart program? Of course, exceptional patient care and safety together are the top priorities. Following closely from an organizational point of view are family and visitor comforts and staff workflows, conveniences, efficiencies and comfort. The intention was
One of America’s Top Heart Hospitals - US News & World Report
The University of Kansas Hospital Center for Advanced Heart Care CORONARY HEART ™ 11
Building A Heart Center (cont...) to provide a great environment in which all staff is supported to provide exceptional patient care. Design decisions were driven using the guidance of our organizational pillars of quality, service, people, cost and growth. Quality outcomes and care are most important, of course. Design that allowed for superior service, from curbside to bedside, and patient satisfaction were always taken into account. Satisfaction and retention of nursing staff, physicians and other support/ancillary staff were also considered in workflow designs.
We determined that the facility should allow for program expansion and growth, so design decisions needed to be based on that. And, of course, we had to consider how design, flow and equipment selection could be cost efficient and long lasting. Our internal clinical design team, composed of clinical staff, including nurses and physicians, began meeting with the RTKL architects in 2003. A general scheme had been developed; however, the clinical team provided essential information to create thoughtful and functional patient
care areas. Throughout the process, the focus continued to be on patient care and safety, along with efficiency of that care for both nursing staff and physicians. From the beginning, we determined it was very important to provide staff respite areas/lounges with generous square footage, natural light and amenities. Staff lounges for five of the seven units in our heart center are located on the corner of the building, providing wonderfully big, beautiful, light-filled areas. All of the lounges contain many staff conveniences that
The Foyer: The colourful hanging sculpture is called a PulseFlow composed of more than 300 pieces of blown glass. 12â€ƒ CORONARY HEART â„˘
offer some relaxation and rejuvenation as staff members continue to provide great care to patients. We also chose to make the staff areas calm and quiet, providing comfort to those who provide so much comfort to others.
Patient Rooms: Every patient has a private room, and most have wireless internet access.
Staff support was and remains an important aspect of the Center for Advanced Heart Care. Early in the process, space was set aside for physician and support staff work areas, and they were designed into each patient care area. These work areas provide computers, phones and storage space in quiet, private locations.
A Focus on Patient Care and Comfort We paid considerable attention to all patient rooms. Clinical staff made significant contributions to the design, resulting in space that makes sense to staff as they provide care. Patient rooms also feature family areas or zones for family and visitor comfort. Small workspaces with computer access and in-room sleeper sofas are included. There are also six guest suites on the inpatient progressive care units. Suites include attached guest areas for greater privacy, as needed. A beautifully planned education area for families and patients, located on the second floor, was included to serve as a significant learning and support resource for all patients and families. Additionally, spaces were specifically planned for the display of art, adding to the building’s beautiful, healing atmosphere. The magnificently spacious entrance to the Center for Advanced Heart Care is filled with
light and beauty; natural light and a hanging glass sculpture create a soothing, healing space. Easy wayfinding also was incorporated into design. Specific colors identify each floor, and related art identifies space, such as waiting areas. As the design process continued, patient care areas were painstakingly reviewed unit by unit. Another important consideration that upheld the guiding principle of patient safety was the consistency of units from floor to floor. Nurse work areas are similarly stocked and organized throughout the facility. Universal placement and design allow for safer and more consistent patient care. This concept also allows for physician efficiencies, reducing rounding time spent looking for forms, charts, etc. An overall look at all areas ensured
appropriate and efficient patient care and workflows between areas. All work- and patient flows were specifically detailed and diagramed to ensure that the intended designs would work in practice. These flow diagrams were also used extensively in orientation training for the facility. Early in the planning, we decided that nursing and supportive care would be decentralized. This meant designing the nurse work areas so they are within steps of the patient beds, allowing nurses to easily see patients and stay close to keep them safe. Architects worked with the clinical team to draw sight lines from each patient’s room to various areas on the unit, ensuring visual lines of sight into each patient’s room from multiple points on the unit No patient rooms were tucked away out of a nurse’s or other care provider’s sight. CORONARY HEART ™ 13
Building A Heart Center (cont...)
Cath Lab Floor Plan Another of our priorities was to eliminate unnecessary steps for staff to obtain supplies, medications and other patient care items. As a result, plans called for necessary supplies, materials
and medicals records to be located at workstations just outside of each patient room. Computers, phones, medications and supplies are only a few steps away from patients. Close-
by nutrition centers store the supplies that could not be kept at workstations, including clean supplies and additional medications.
Designing for Advanced Services
Cardiology Inpatient Floor Plan 14â€ƒ CORONARY HEART â„˘
Other important aspects of most heart programs were taken into consideration. For example, doorto-balloon time, a performance improvement initiative, is closely monitored. To continue ensuring the ease and speed of care delivery, we carefully designed a plan for moving patients from ambulance, helicopter or the Emergency Department to the catheterization lab in reduced time. A new state-of-the-art Emergency Department was designed and built on the first level of the Center for Advanced Heart Care, allowing us to improve door-to-balloon times and quickly transport patients to our cardiac catheterization labs or to the
chest pain center, when appropriate. Also important to the design was the close proximity of patient care areas. For example, on the second level, which houses the cardiac catheterization and electrophysiology (EP) labs, the floor was laid out to include the labs, the Cardiovascular Treatment and Recovery (which is a prep and recovery area) and the Cardiac Intensive Care Unit. This permits the availability of RNs with a wide scope of competencies (ICU, recovery and procedural), immediate physician availability and ease of movement from one area to another. These efficiencies provide a serviceorientation to physicians and patients, along with continued focus on patient care and safety. Help is never far away. The same concept applies to the cardiothoracic surgery floor. The CVORs and the Cardiothoracic Surgery ICU are housed on a single floor, again providing access to critical care and surgical nurses and to surgeons and anesthesiologists. This floor also has a satellite pharmacy, which serves the CVORs and all ICUs in the heart center and prepares all stat medications for the entire facility. Cardiac catheterization and EP labs and CVORs are challenging and innovative areas for design. The CV labs, which include the cardiac catheterization and EP labs and the CVORs are big, remarkable areas with state-of-the-art equipment and nursedesigned workstations. The layout was planned with significant physician and staff input. To minimize time spent running for an item, some supply storage is inside the CV labs, as well as a larger stock area.
Decentralized Nursing Stations: Allowing nurses to be only steps away from their patients.
Names and titles from left to right: Mike Kaiser - PA, Shirley Verbenec - CV OR, Lynette Patocka - CV OR, Zann Roach - EP Lab, Chris Buckley - CTS ICU, Lynn Smith - Cath Lab, Annie Burger - CTS PCU, Kathy Carson - CTS ICU, Gail Schuman - CV Pre/ Post, Kate Jones - CTS Nurse Clinician, Andy Hawthorne - CTS ICU, Anna Werner - CTS PCU
Equipment selection, a tricky endeavor, could be described in an article of its own. Again, physician input is critical, as is having team members who are well versed or researched in the various equipment and options. It is also important to have someone who is very comfortable with negotiations and contracts. Many questions must be asked to make wise, cost-conscious decisions.
The University of Kansas Hospital’s Center for Advanced Heart Care opened in October 2006. The major project required the help of hundreds of people – design team, staff, community members, patients and families. We are very proud of our facility. It is a place where excellent, quality care continues to be delivered by a dedicated, committed and caring team. And the quality of care will remain at the heart of its existence.
Opening the Heart Center Design and construction soon were completed. The task of moving in, occupying and opening units, and making them operational soon became the focus of the clinical team. That successful accomplishment is also a story unto itself, for another day.
The University of Kansas Hospital Center for Advanced Heart Care 3901 Rainbow Blvd. Kansas City, KS 66160 United States of America CORONARY HEART ™ 15
Anti-coagulation Clinic’s A Patients Newest Best Friend
Dennis Holloway, MBA, CVT Director Invasive/Non-Invasive Cardiology Sarasota Memorial Hospital Sarasota, Florida
Anti-Coagulation Clinics have begun a new era in aiding patients in therapeutic maintenance and initial treatment for diseases requiring short or long term drug therapy. Consistent monitoring of INR’s, medication adjustments, patient education, and knowledge of blood lab values has been an uphill battle; until now!
ocated in the “heart” of downtown Sarasota stands “Sarasota Memorial Hospital’s” “Heart Vascular Institute (HVI)”. One of the major services located here is their “AntiCoagulation Clinic”. The clinic is staffed with 1 ARNP, 2 RN’s, 1 LPN, 2 Patient Representative III’s, 1 Ancillary Representative III, a department Manager, Department Director and Medical Director. Janet Delany, ARNP is a Board Certified Anticoagulation Provider. Janet is among an elite group of only 17 within the state of Florida to hold this title. Each nurse is required to take the anticoagulation course provided at the University of Southern Indiana on an annual basis. The Anticoagulation Clinic first opened its doors in 2003 and has demonstrated a remarkable growth each year. For fiscal year 2007 its volume prediction was estimated to be a 12% increase from FY06. The current analysis has them on track at 20%. As more and more physicians become aware of the success and/or value of this service their referrals for anticoagulation therapy in this clinic are ever-growing. Physicians that refer patients to the clinic include, but are not limited to: a. Primary Care
Sarasota Memorial Hospital, Heart Vascular Institute, Anticoagulation Clinic.
b. Internal Medicine c. Cardiologists d. Pain Management e. Pulmonary f.
16 CORONARY HEART ™
g. Orthopedic h. Surgical
What Category of Patient Types are Seen? The Sarasota Memorial Hospital Anticoagulation Clinic sees between 80 to 100 patients a day. These patients range from a variety of clinically diagnosed diseases, some of which include: a. Atria fibrillation b. Pulmonary Emboli (PE) c. Transient Ischemic Attack (TIA) d. Cerebral Vascular Attack (CVA) e. Thrombophilia f.
Vein Thrombosis Emboli (VTE)
g. Heart Disease h. Valve Disease i.
Medications Dependant on the diagnosis, the type(s) of medications necessary for treatment vary. The following list contains the major pharmaceutical listing of medications our patients would receive: a. Coumadin (Warfarin Sodium): An anticoagulant (blood thinner) which acts by inhibition vitamin K-dependent coagulation factors which include Factors II, VII and
X and the anticoagulant proteins C and S. Coumadin is absorbed through oral intake with peak affect in about 4 hours. b. Lovenox: (enoxaparin): Lowmolecular-weight heparin (LMWH) indicated for prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement, or patients with severely restricted mobility during acute illness. It is also used for prophylaxis of ischemic complication so of unstable angina and non-Q-wave myocardial infarction, treatment of acute deep vein thrombosis and treatment of acute ST-segment Elevation Myocardial Infarction (STEMI). c. Vitamin K: (Generic): Made up of 2-methyl-1 & 4naphthoquinone ring structures providing hemostatic traits. Originally found in green leafy vegetables, hemp, seeds, liver and fish meal. Vitamin K resides in certain proteins in the body. These proteins include the vitamin K-dependent coagulation factors II, VII, IX, X, protein C, protein S, protein Zv and a growth arrest-specific factor. Vitamin K is also key element in bone metabolism. Vitamin K is the collective term for a group of vitamin K compounds called menaquinones. Vitamin K is used to treat anticoagulant-induced prothrombin deficiency caused by warfarin, hypoprothrombinemia. d. Jantoven: This is a generic medication substituted for Coumadin by Publix Pharmacy’s. “Point of Care” testing includes
utilizing the “International Technidyne Corporation (ITC)” blood value for “international normalized ratio (INR)” results. According to a study published in the “New England Journal of Medicine by Elaine M. Hylek, MD, Massachusetts General Hospital, Boston Massachusetts, and colleagues showed that an INR >/=2.0 at the time of stroke reduced the incidence and severity of ischemic stroke, as well as the risk of 30-day mortality from stroke patients with nonvalvular AF, compared with an INR < 2.0, aspirin therapy, or no therapy at all (5).” Therapeutic measures used at this clinic follow the “American College of Surgical Chest Physicians, Jack Ansell’s Publications on Anticoagulation Forum, the Davis Health Center, and Berkley Health Center.
What to Expect on a Patients Initial Visit Once a referral has been faxed into the Anticoagulation Clinic, it is picked up by the Patient Representative. She then contacts the patient and schedules him/her for their initial visit with the ARNP. Once the patient arrives, he/she will check in at the front desk with one of the Patient Relations Representatives. Patients arriving for their initial visit will meet with the ARNP to compete a thorough History and Physical. All patients arriving for their initial visit will watch an instructional video, review prepared educational material, and take and exam which will assess the patient’s knowledge of outpatient anticoagulation. During this visit the patient will undergo a capillary blood test to determine their INR. Once the INR results are processed (this is a Point of Care test; therefore, whereas the results are close to
immediate) the ARNP can clinically diagnose if the patient is within therapeutic range of their particular disease guidelines. The patient will then be given a written dosage regimen, review their exam, clarify their education and have any questions answered. Patients are also provided with information on how to maintain a healthy lifestyle, when to notify the ACC and what to do should an adverse event occur. They are also provided with local and internet resources for education and services. As the initial visit process continues, the patient will be contacted by the Patient Relations Representatives to schedule concurrent visits. The immediate follow-up visit will be weekly for a period of 4 weeks. This is to ensure that the patient is monitored closely for INR levels, change of medicine (if appropriate) and new dosing adjustments if necessary. Blood tests are taken on each visit. This is probably the part most patients don’t like, but is vital in perfecting their therapy. Upon completion of these 4 weeks, the patient will be scheduled on a monthly or as-needed basis.
Guidelines/Tools As with any clinical program, regulations, guidelines, programs and/or processes are in place to aide the clinical staff in determining the appropriate ranges or steps necessary to give our patients the best care possible. As a result of her specialized experience in this field, Janet Delaney, ARNP, has developed a guideline of therapy that has been accepted by many physicians or practitioners in our area. This tool is referred to as the Lovenox Decision Making Protocol, and is seen on the following page. CORONARY HEART ™ 17
LOVENOX DECISION MAKING PROTOCOL
PATIENT NAME_____________________________________ DATE___________________________ Risk of thromboembolism LOW VTE > 6 months ago AFIB with CHADS2 of 0-1 Bileaflet/ Mech AVR w/o CVA RF Cerebrovascular disease without TIA/ CVA
MODERATE VTE >3mos. <6mos. AFIB with CHADS2 of 2-3
HIGH VTE/AE within 3 months AFIB with CHADS2 of 4-6 or AFIB with RHD Bileaflet/ Mech AVR + CVA RF older Mech MVR or older Mech AVR (caged Mech AVR w/o CVA RF ball/tilt disk) Cerebrovascular disease with CVA/TIA Cerebrovascular disease with rec. CVA/ (no Afib) TIA +AFIB. Previous VTE post surgery New prosthetic valve/ or w/RF St. Jude Mech MVR Intracardiac Thrombus TE event with Thrombophilia TE event with Active CA
CHADS 2 Score for AFIB CONDITION Congestive Heart Failure (any history) Hypertension (prior history) Age (>75 years) Diabetes Prior ischemic stroke or TIA
CVA risk factors SCORE 1 1 1 1 2
Procedural Bleeding Risk HIGH Heart Valve Replacement/CABG Spinal anesthesia/Epidural analgesia Abdominal/Thoracic Aneurysm repair Neurological /urologic / head & neck/ abdominal / breast cancer surgeries Bilateral knee replacement Laminectomy TURP Kidney Biopsy Polypectomy/variceal repair/biliary sphincterectomy, pneumatic dilation PEG placement Endoscopically guided fine needle aspiration Multiple tooth extractions Vascular and General surgery Any major surgery > 45 minutes in length
18 CORONARY HEART ™
MODERATE/ LOW Cholecystectomy Adbominal hysterectomy Simple dental extractions GI endo w/wo biopsy, enteroscopy, biliary/pancreatic stent Carpel tunnel repair D&C Skin cancer excision Abdominal hernia repair Knee/ hip /shoulder/ foot/ hand surgery or arthroscopy Hip and Shoulder replacement Hemorrhoidal surgery Axillary node dissection Hydrocele repair Noncoronary angiography Cataract and noncataract eye surgery Pacer/defibrillator/EP testing
Anti-Coagulation Clinic’s (cont...) Evaluation of Risks THROMBOEMBOLISM Low Risk Moderate Risk
Pre/Post Procedure Prophylactic Pre Post Prophylactic Pre Post or Full dose Full dose Pre Post
Anticoagulation Clinics provides a superior service which enables the highest level of “standard of care” for those patients who develop one of the many disease categories. I can not think of anyone better to treat these patients in collaboration with physicians, than the specialized clinical professionals dedicated to anticoagulation therapy. Anticoagulation Clinics are not only clinically productive, but financially beneficial as well. The best of both worlds for facilities and patients alike.
References 1. PDR Health: Vitamin K; Coumadin 2. Bristol-Myers Squibb Company: Coumadin Tablets; Coumadin for Injection 3. Lovenox.com: About Lovenox 4. International Technidyne Corporation: About ITC 5. Medscape.com: “Study suggests Optimal INR Value for Anticoagulation Therapy to Reduce Stroke Severity and Mortality in Patients with AF”
CORONARY HEART ™ 19
CARDIAC SITE VISIT
UNITED STATES OF AMERICA
The Mayo Clinic
- EP Department
ADDRESS Mayo Clinic 200 First St. S.W. Rochester, MN 90 United States of America
FAST FACTS 1. Arguably the world’s most recognized medical institution 2. Six dedicated EP Labs. 3. Approximately 20 procedures per year. 4. Stereotaxis Niobe (current) & Hansen (coming soon).
“The best interest of the patient is the only interest to be considered.” - Dr Will J. Mayo
he Mayo Clinic is regarded internationally as one of the top medical institutions in the world, and has won countless awards for the high levels of service and care. This care is supported by advanced programs in medical education and research, utilizing the latest technology medical companies have to offer. Patients fly from all over the world to be treated here, however although you would expect to find the Mayo Clinic in the center of a state capital, the reality is vastly different. The Mayo is located in the regional city of Rochester surrounded by Amish farming communities in the southeast of Minnesota, one hour from Minneapolis. Rochester is the third largest city in the state with a population of 94,000, one third of which are employed at the Mayo Clinic. The city is also home to one of IBM’s largest facilities, and has long been a fixture on Money magazine’s “Best Places to Live” index, and was ranked number 67 on the 2006 list. During our visit in September with the sun shining each day, we almost considered moving here.
courtesy of Mayo Clinic
The following pages will provide you with a brief history of how the Mayo Clinic came about, followed by a look inside the world class Electrophysiology Department and an interview with the EP Department manager, Mr Douglas Beinborn. In 2008/09 we hope to return to the Mayo to perform a site visit on the interventional and non-invasive sides. 20
CORONARY HEART ™
CARDIAC SITE VISIT
“The injured are picked up, and at once taken to the hospital. Truly this is quite as astonishing as any of the fairy tales.”
n 1846, Dr William Worrall Mayo emigrated from England where he was born, to the United States, training to become a doctor in 1850. In 1864 his family moved to Rochester, after being appointed as a civil war examining surgeon for the Union enrollment board the year prior.
Here Dr Mayo trained his two sons, William J. and Charlie in medicine, first by observing, followed by assisting with autopsies. They both then went on to medical school before returning to their father’s practice. It was however a tornado that ravaged Dr William Worrall Mayo, 1907 the town in 1863, killing and injuring As the family practice became bigger many that Nuns from the Sisters of St and medical knowledge was increasing Francis (who acted as nurses), and the rapidly, others joined the group. Mayo Doctors combined to build the Eventually the team created a new first general hospital in southeastern system of health care, with the creation Minnesota - the 27-bed Saint Marys of the USA’s first medical specialities. Hospital which opened in 1889. Dr William Mayo and his sons
courtesy of Mayo Clinic
Right from the beginning the Mayo was at the forefront of patient care. In 1969 on a trip to New York, Dr W.W. Mayo saw for the first time civilian ambulances transporting patients in the city, amazed that doctors no longer did house calls. He later wrote, “When an accident occurs in any part of the city, there is a dispatch sent ... and the ambulance is on the ground a few minutes after. The injured are picked up, and at once taken to the hospital. Truly this is quite as astonishing as any of the fairy tales.”
The Mayo Brothers Dr. Charlie (left) and Dr. Will
Sure enough, once St Marys Hospital was built the Mayo Drs purchased a horse-drawn ambulance from the Studebaker Company. 1.
once said, “no one is big enough to be independent of others.” In other words, medicine has become so complex that it requires a team of physicians, specialists, medical professionals and scientists all working together to provide the absolutely best medical care. 2. Since those days more than eight million people have been treated at Mayo Clinic, and staying true to their word, the patient always comes first.
1 http://www.mayoclinic.org/news2007-rst/3897. html 2 http://www.mayoclinic.org/tradition-heritage/ model-care.html
CORONARY HEART ™ 21
courtesy of Mayo Clinic
CARDIAC SITE VISIT
Mayo Clinic (cont...) MAYO CLINIC ELECTROPHYSIOLOGY DEPARTMENT
ith the Mayo Clinic in Rochester, MN due to its size and international interest we have to break away from our traditional site visit articles and separate it into two parts: EP and Cath. In this edition we will look at the EP department which we visited in mid September 2007. The following questions have been answered by Mr Douglas Beinborn, the EP Department Manager.
Inserting a Pacemaker
Size of the EP Department: We operate six procedure rooms on a daily basis.
Staff numbers • • • • • •
18 technical staff 21 physicians 35 RN’s 3 mid-level providers 4 secretaries 4 schedulers
• • • • • • •
We cross-train within the lab. We share a prep/recovery with the cath lab.
Carto ESI ICE Laser extraction Prucka recording Cryo-ablation Stereotaxis
Variety of inpatient and outpatient procedures
We utilize RCIS and CVT’s who perform the same role. We have CRNA’s in four of our procedure rooms who provide deep sedation to general anesthesia. RN’s are crosstrained to work in the procedure rooms, our clinic, and hospital service.
Procedures performed per year:
New procedures implemented:
• • • •
Day Procedures: Procedures: • • • • • • •
Ablation, Diagnostic EP, Tilt table studies, Long QT testing, ICD implants including biventricular, PM implants including biventricular, lead extraction, Implantable loop recorders
22 CORONARY HEART ™
900 ablations, 1200 device implants, 350 tilts/long QT tests. 200 EP diagnostic studies.
Epicardial ablation, Tandem heart for complex VT ablation, Carto Sound.
CARDIAC SITE VISIT
Inventory Management: We work cooperatively with Mayo Materials Management and a number of our own internal staff to manage our inventories and charging in relation to usage
Hemostasis Management: Complex to cover here. Some cases heparin is reversed, most of the time we wait for ACT to be <180 prior to sheath removal
Measures implemented to cut costs: Extensive work has been done on materials management. Topics include consignment, utilization rates, automation with reordering, cost negotiation. Currently working on lab efficiencies.
Training for new employees: Formal orientation process has been developed. Staff are assigned a preceptor with outlines and goals set of the orientee and preceptor.
Siemens EP Lab with Stereotaxis Niobe The entire EP department will soon be comprised of all new Siemens imaging equipment.
EP training facility for cardiac fellows: We have four senior fellows each year.
Continuing education programs for staff: • •
We have core curriculum every Monday that are EP in origin. Ability of staff to attend conferences outside of Mayo.
Competency checks for staff: •
• • • • •
ACLS, Infection control, Safety, Equipment competency, Procedural competencies (recording system, stimulator, device programmers, etc)
What is the best part of working at your facility? Highly dedicated staff, teamwork, innovation, access to the latest technology, challenging but rewarding work environment.
BLS, CORONARY HEART ™ 23
We’re shedding more New evidence confirms what we’ve known all along.
The CARE study found no statistically significant difference between Isovue® and Visipaque™ in the rate of CIN in high-risk patients undergoing cardiac angiography or PCI. The CARE study is the largest, prospective, randomized, double-blind comparison of iso-osmolar iodixanol-320 with low-osmolar iopamidol-370 in high-risk patients.1
Read the CARE study today. Visit CARECIN.com Call Bracco Sales Center at 1-866-282-2895 or call Bracco Professional Services at 1-800-257-5181 option #2 Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. As with all injectable contrast agents, the possibility of severe reactions should be borne in mind, regardless of the patient’s pre-existing medical history. Please see brief summary of Prescribing Information on the following page. Reference: 1. Solomon RJ, Natarajan MK, Doucet S, et al, and the Investigators of the CARE study. The CARE (Cardiac Angiography in REnally Impaired Patients) study: a randomized, double-blind trial of contrast-induced nephropathy in high-risk patients. Circulation. 2007;115:3189-3196.
Visipaque is a trademark of GE Healthcare. ©BDI 2007
light on CIN.
CARE study: CIN* incidence in at-risk patients 1a.
Isovue®-370 Visipaque 320
Isovue®-370 Visipaque 320
• There was no statistical difference in the incidence of CIN (SCr r0.5 mg/dL) following iopamidol-370 and iodixanol-320 (see Figure 1a)1 • The rates of SCr increases r25% were not significantly different (see Figure 1b)1 • The rates of eGFR decreases r25% were not significantly different (see Figure 1c)1 * CIN defined as a) an absolute increase r0.5 mg/dL, b) a relative increase r25% in serum creatinine or c) a r25% decrease in eGFR from baseline to 45-120 hours postcontrast. †
% Patients With Decrease in eGFR ≥25%
% Patients With Increase in SCr ≥25%
% Patients With Increase in SCr ≥0.5 mg/dL
P value is not statistically significant.
Isovue®-370 Visipaque 320 TM
BRACCO DIAGNOSTICS Rx only Rx only
0LEASE SEE FULL PRESCRIBING INFORMATION ! BRIEF SUMMARY FOLLOWS 0LEASE SEE FULL PRESCRIBING INFORMATION ! BRIEF SUMMARY FOLLOWS
Iopamidol Injection 41%
Iopamidol Injection 61%
ISOVUE -250 Injection ISOVUE -370 Iopamidol 76% Iopamidol Injection 51% Iopamidol Injection 76% Â®
NOT FOR INTRATHECAL USE
)3/65% AND ARE ./4 &/2 ).42!4(%#!, 53% 3EE )NDICATIONS AND $OSAGE AND !DMINISTRATION SECTIONS FOR FURTHER DETAILS ON PROPER USE $)!'./34)# ./.)/.)# 2!$)/0!15% #/.42!34 -%$)! &OR !NGIOGRAPHY 4HROUGHOUT THE #ARDIOVASCULAR 3YSTEM )NCLUDING #EREBRAL AND 0ERIPHERAL !RTERIOGRAPHY #ORONARY !RTERIOGRAPHY AND 6ENTRICULOGRAPHY 0EDIATRIC !NGIOCARDIOGRAPHY 3ELECTIVE 6ISCERAL !RTERIOGRAPHY AND !ORTOGRAPHY 0ERIPHERAL 6ENOGRAPHY 0HLEBOGRAPHY AND !DULT AND 0EDIATRIC )NTRAVENOUS %XCRETORY 5ROGRAPHY AND )NTRAVENOUS !DULT AND 0EDIATRIC #ONTRAST %NHANCEMENT OF #OMPUTED 4OMOGRAPHIC #%#4 (EAD AND "ODY )MAGING #/.42!).$)#!4)/.3 .ONE 7!2.).'3 3EVERE !DVERSE %VENTS LNADVERTENT )NTRATHECAL !DMINISTRATION 3ERIOUS ADVERSE REACTIONS HAVE BEEN REPORTED DUE TO THE INADVERTENT INTRATHECAL ADMINISTRATION OF IODINATED CONTRAST MEDIA THAT ARE NOT INDICATED FOR INTRATHECAL USE 4HESE SERIOUS ADVERSE REACTIONS INCLUDE DEATH CONVULSIONS CEREBRAL HEMORRHAGE COMA PARALYSIS ARACHNOIDITIS ACUTE RENAL FAILURE CARDIAC ARREST SEIZURES RHABDOMYOLYSIS HYPERTHERMIA AND BRAIN EDEMA 3PECIAL ATTENTION MUST BE GIVEN TO INSURE THAT THIS DRUG PRODUCT IS NOT INADVERTENTLY ADMINISTERED INTRATHECALLY 'ENERAL .ONIONIC IODINATED CONTRAST MEDIA INHIBIT BLOOD COAGULATION IN VITRO LESS THAN IONIC CONTRAST MEDIA #LOTTING HAS BEEN REPORTED WHEN BLOOD REMAINS IN CONTACT WITH SYRINGES CONTAINING NONIONIC CONTRAST MEDIA 3ERIOUS RARELY FATAL THROMBOEMBOLIC EVENTS CAUSING MYOCARDIAL INFARCTION AND STROKE HAVE BEEN REPORTED DURING ANGIOGRAPHIC PROCEDURES WITH BOTH IONIC AND NONIONIC CONTRAST MEDIA 4HEREFORE METICULOUS INTRAVASCULAR ADMINISTRATION TECHNIQUE IS NECESSARY PARTICULARLY DURING ANGIOGRAPHIC PROCEDURES TO MINIMIZE THROMBOEMBOLIC EVENTS .UMEROUS FACTORS INCLUDING LENGTH OF PROCEDURE CATHETER AND SYRINGE MATERIAL UNDERLYING DISEASE STATE AND CONCOMITANT MEDICATIONS MAY CONTRIBUTE TO THE DEVELOPMENT OF THROMBOEMBOLIC EVENTS &OR THESE REASONS METICULOUS ANGIOGRAPHIC TECHNIQUES ARE RECOMMENDED INCLUDING CLOSE ATTENTION TO GUIDEWIRE AND CATHETER MANIPULATION USE OF MANIFOLD SYSTEMS ANDOR THREE WAY STOPCOCKS FREQUENT CATHETER mUSHING WITH HEPARINIZED SALINE SOLUTIONS AND MINIMIZING THE LENGTH OF THE PROCEDURE 4HE USE OF PLASTIC SYRINGES IN PLACE OF GLASS SYRINGES HAS BEEN REPORTED TO DECREASE BUT NOT ELIMINATE THE LIKELIHOOD OF IN VITRO CLOTTING #AUTION MUST BE EXERCISED IN PATIENTS WITH SEVERELY IMPAIRED RENAL FUNCTION THOSE WITH COMBINED RENAL AND HEPATIC DISEASE OR ANURIA PARTICULARLY WHEN LARGER OR REPEAT DOSES ARE ADMINISTERED 2ADIOPAQUE DIAGNOSTIC CONTRAST AGENTS ARE POTENTIALLY HAZARDOUS IN PATIENTS WITH MULTIPLE MYELOMA OR OTHER PARAPROTEINEMIA PARTICULARLY IN THOSE WITH THERAPEUTICALLY RESISTANT ANURIA -YELOMA OCCURS MOST COMMONLY IN PERSONS OVER AGE !LTHOUGH NEITHER THE CONTRAST AGENT NOR DEHYDRATION HAS BEEN PROVED SEPARATELY TO BE THE CAUSE OF ANURIA IN MYELOMATOUS PATIENTS IT HAS BEEN SPECULATED THAT THE COMBINATION OF BOTH MAY BE CAUSATIVE 4HE RISK IN MYELOMATOUS PATIENTS IS NOT A CONTRAINDICATION HOWEVER SPECIAL PRECAUTIONS ARE REQUIRED #ONTRAST MEDIA MAY PROMOTE SICKLING IN INDIVIDUALS WHO ARE HOMOZYGOUS FOR SICKLE CELL DISEASE WHEN INJECTED INTRAVENOUSLY OR INTRAARTERIALLY !DMINISTRATION OF RADIOPAQUE MATERIALS TO PATIENTS KNOWN OR SUSPECTED OF HAVING PHEOCHROMOCYTOMA SHOULD BE PERFORMED WITH EXTREME CAUTION )F IN THE OPINION OF THE PHYSICIAN THE POSSIBLE BENElTS OF SUCH PROCEDURES OUTWEIGH THE CONSIDERED RISKS THE PROCEDURES MAY BE PERFORMED HOWEVER THE AMOUNT OF RADIOPAQUE MEDIUM INJECTED SHOULD BE KEPT TO AN ABSOLUTE MINIMUM 4HE BLOOD PRESSURE SHOULD BE ASSESSED THROUGHOUT THE PROCEDURE AND MEASURES FOR TREATMENT OF A HYPERTENSIVE CRISIS SHOULD BE AVAILABLE 4HESE PATIENTS SHOULD BE MONITORED VERY CLOSELY DURING CONTRAST ENHANCED PROCEDURES 2EPORTS OF THYROID STORM FOLLOWING THE USE OF IODINATED RADIOPAQUE DIAGNOSTIC AGENTS IN PATIENTS WITH HYPERTHYROIDISM OR WITH AN AUTONOMOUSLY FUNCTIONING THYROID NODULE SUGGEST THAT THIS ADDITIONAL RISK BE EVALUATED IN SUCH PATIENTS BEFORE USE OF ANY CONTRAST MEDIUM
3ELECTIVE CORONARY ARTERIOGRAPHY SHOULD BE PERFORMED ONLY IN SELECTED PATIENTS AND THOSE IN WHOM THE EXPECTED BENElTS OUTWEIGH THE PROCEDURAL RISK 4HE INHERENT RISKS OF ANGIOCARDIOGRAPHY IN PATIENTS WITH PULMONARY HYPERTENSION MUST BE WEIGHED AGAINST THE NECESSITY FOR PERFORMING THIS PROCEDURE !NGIOGRAPHY SHOULD BE AVOIDED WHENEVER POSSIBLE IN PATIENTS WITH HOMOCYSTINURIA BECAUSE OF THE RISK OF INDUCING THROMBOSIS AND EMBOLISM 3EE ALSO 0EDIATRIC 5SE )N ADDITION TO THE GENERAL PRECAUTIONS PREVIOUSLY DESCRIBED SPECIAL CARE IS REQUIRED WHEN VENOGRAPHY IS PERFORMED IN PATIENTS WITH SUSPECTED THROMBOSIS PHLEBITIS SEVERE ISCHEMIC DISEASE LOCAL INFECTION OR A TOTALLY OBSTRUCTED VENOUS SYSTEM %XTREME CAUTION DURING INJECTION OF CONTRAST MEDIA IS NECESSARY TO AVOID EXTRAVASATION AND mUOROSCOPY IS RECOMMENDED 4HIS IS ESPECIALLY IMPORTANT IN PATIENTS WITH SEVERE ARTERIAL OR VENOUS DISEASE )NFORMATION FOR 0ATIENTS 0ATIENTS RECEIVING INJECTABLE RADIOPAQUE DIAGNOSTIC AGENTS SHOULD BE INSTRUCTED TO )NFORM YOUR PHYSICIAN IF YOU ARE PREGNANT )NFORM YOUR PHYSICIAN IF YOU ARE DIABETIC OR IF YOU HAVE MULTIPLE MYELOMA PHEOCHROMOCYTOMA HOMOZYGOUS SICKLE CELL DISEASE OR KNOWN THYROID DISORDER SEE 7!2.).'3 )NFORM YOUR PHYSICIAN IF YOU ARE ALLERGIC TO ANY DRUGS FOOD OR IF YOU HAD ANY REACTIONS TO PREVIOUS INJECTIONS OF SUBSTANCES USED FOR X RAY PROCEDURES SEE 02%#!54)/.3 'ENERAL )NFORM YOUR PHYSICIAN ABOUT ANY OTHER MEDICATIONS YOU ARE CURRENTLY TAKING INCLUDING NONPRESCRIPTION DRUGS BEFORE YOU HAVE THIS PROCEDURE $RUG )NTERACTIONS 2ENAL TOXICITY HAS BEEN REPORTED IN A FEW PATIENTS WITH LIVER DYSFUNCTION WHO WERE GIVEN ORAL CHOLECYSTOGRAPHIC AGENTS FOLLOWED BY INTRAVASCULAR CONTRAST AGENTS !DMINISTRATION OF INTRAVASCULAR AGENTS SHOULD THEREFORE BE POSTPONED IN ANY PATIENT WITH A KNOWN OR SUSPECTED HEPATIC OR BILIARY DISORDER WHO HAS RECENTLY RECEIVED A CHOLECYSTOGRAPHIC CONTRAST AGENT /THER DRUGS SHOULD NOT BE ADMIXED WITH IOPAMIDOL $RUG,ABORATORY 4EST )NTERACTIONS 4HE RESULTS OF 0") AND RADIOACTIVE IODINE UPTAKE STUDIES WHICH DEPEND ON IODINE ESTIMATIONS WILL NOT ACCURATELY REmECT THYROID FUNCTION FOR UP TO DAYS FOLLOWING ADMINISTRATION OF IODINATED CONTRAST MEDIA (OWEVER THYROID FUNCTION TESTS NOT DEPENDING ON IODINE ESTIMATIONS EG 4 RESIN UPTAKE AND TOTAL OR FREE THYROXINE 4 ASSAYS ARE NOT AFFECTED !NY TEST WHICH MIGHT BE AFFECTED BY CONTRAST MEDIA SHOULD BE PERFORMED PRIOR TO ADMINISTRATION OF THE CONTRAST MEDIUM ,ABORATORY 4EST &INDINGS )N VITRO STUDIES WITH ANIMAL BLOOD SHOWED THAT MANY RADIOPAQUE CONTRAST AGENTS INCLUDING IOPAMIDOL PRODUCED A SLIGHT DEPRESSION OF PLASMA COAGULATION FACTORS INCLUDING PROTHROMBIN TIME PARTIAL THROMBOPLASTIN TIME AND lBRINOGEN AS WELL AS A SLIGHT TENDENCY TO CAUSE PLATELET ANDOR RED BLOOD CELL AGGREGATION SEE 02%#!54)/.3 'ENERAL 4RANSITORY CHANGES MAY OCCUR IN RED CELL AND LEUCOCYTE COUNTS SERUM CALCIUM SERUM CREATININE SERUM GLUTAMIC OXALOACETIC TRANSAMINASE 3'/4 AND URIC ACID IN URINE TRANSIENT ALBUMINURIA MAY OCCUR 4HESE lNDINGS HAVE NOT BEEN ASSOCIATED WITH CLINICAL MANIFESTATIONS #ARCINOGENESIS -UTAGENESIS )MPAIRMENT OF &ERTILITY ,ONG TERM STUDIES IN ANIMALS HAVE NOT BEEN PERFORMED TO EVALUATE CARCINOGENIC POTENTIAL .O EVIDENCE OF GENETIC TOXICITY WAS OBTAINED IN IN VITRO TESTS 0REGNANCY 4ERATOGENIC %FFECTS 0REGNANCY #ATEGORY "