A World Class Program. . .

This year’s SCA&I annual meeting will be trulyspecial, with an incredible array of renownedspeakers and gifted teachers. Thanks to theSeattle Program Committee, the “Best of the Bestin Interventional Cardiology” will be the themeof this not-to-be-missed meeting.

Much more than a catchphrase, “the Best ofthe Best” is the benchmark used by the ProgramCommittee to design this year’s program. TheScientific Sessions will provide you the latestabout new technologies, best practices, latebreaking trials and more in a field that is chang-ing at breathtaking speed.

Hearing all the excitement about coated stentsand other new interventions? Learn the latest fromresearchers designing these new approaches. Uniqueamong interventional meetings, SCA&I’s 25thAnnual Scientific Sessions will give you close inter-action with world-class faculty in “an intellectualfeast” of learning venues.

The Society for Cardiac Angiography and Interventions March 2002

SCA&I News & Highlightswww.scai.org

. . . In a World Class Location!

This year’s Program Committee has designed an exciting social calendar to complement the 25thAnnual Scientific Sessions. At the Annual Banquet,a record number of new Fellows will be formally wel-comed into SCA&I. The President’s Reception, anInternational Reception and other events will addeven more to the camaraderie.

A wide range of sightseeing tours and day tripshave been arranged for your family’s enjoyment. Alsonew this year: Alaska! A spectacular seven-day cruiseto Alaska immediately follows the meeting (specialprice for attendees). Call 1 800 992-7224 for details.

Experience the Pacific Northwest inSpringtime! Lush greenery, glimpses of water every-where—Puget Sound, bays, lakes, rivers, canals andsnow-capped Mount Rainier in the distance emergingfrom the clouds. A visitor soon learns why Seattle isknown as "The Emerald City, " a special place wherepeople sense that their own efforts had better be worthy of this remarkable gift.

Seattle is a welcoming place: the natural bound-aries of hills and water produce a city of neighborhoodsthat feel like small towns, vibrant and intriguing.Quirky or classic, there are limitless opportunities fordiscovery, and endless entertainment for your family.

Rumors of rain in Seattle are greatly exaggerated,with annual rainfall less than New York or Atlanta.When it does rain here (mostly in the winter), it sel-dom pours. The Seattle rain is usually passing showersor a gentle mist, moderate like the climate itself, aunique element of life in "The Emerald City."

We’ll see you there!

SCA&I’s 25th AnnualScientific SessionsSeattle, May 15-18, 2002The Best of the Best in Interventional CardiologyRegistration form page 3

In this issue

1 Seattle Meeting4 President’s Message5 Editor’s Page6 SCA&I News in Brief8 Phantom Benchmark Study9 Important Information from

Industry Sponsors10 SCA&I Advocacy Update11 Hot Topics in Interventional

Cardiology

continued on page 2

2

Highlights of the meet-ing (at the Sheraton Seattle)will include:

� Imaging symposium.The Melvin P. JudkinsCardiac ImagingSymposium (May 15),an intensive full-dayprogram for technolo-gists and physiciansfeaturing the latestimaging technologyand techniques. Featu-red talks: digital imag-ing technology, radia-tion safety, cardiacMRI, image qualityassessment, coronaryflow dynamics andmuch more.

� New technology &techniques. Cuttingedge presentations,late-breaking trials, lectures, interactiveworkshops, cine reviewsessions, manufacturer’s exhibits demonstratingthe latest products and services, and abstractsdescribing original work. Case demonstrationswill illustrate state-of-the-art approaches tochallenging clinical situations.

� Peripheral Vascular Disease Symposium:Intensive half-day course bringing you the latest diagnostic and therapeuticapproaches in this rapidly evolving area.

� Late-breaking findings on coated/drug-eluting stents, brachytherapy, small vesseldisease, distal protection, non-coronaryrevascularization, multi-vessel stenting and dozens of other topics, delivered by theworld’s leading specialists.

� Pediatric interventional cardiology:SCA&I is again proud to offer extensive programming devoted to the interests ofpediatric interventionalists, including core

curriculum (e.g., pul-monary insufficiency,healing response tointravascular devices),oral abstracts, issues incredentialing and manyother topics.� SICP AnnualMeeting: This yearSCA&I is honored that the Society forInvasive CardiovascularProfessionals (SICP) isholding its annual meet-ing in conjunction withSCA&I’s. Technologists,technicians and othermembers of the care teamare urged to participate inall aspects of theScientific Sessions. SICPwill hold its annualreception and committeemeetings at the hotel.� Special events: Awriter’s workshop forprospective scientific

journal authors; Founder’s Lecture (Eric J.Topol, M.D., FSCAI); Hildner Lecture onnew Technologies (Martin Leon, M.D.,FSCAI); demonstrations of medical simula-tion technology for procedures training;industry-sponsored device workshops andsatellite sessions.

The Program Committee extends special grati-tude to Barry F. Uretsky, M.D., FSCAI, FundraisingCommittee Chair, for tireless efforts on behalf ofSCA&I. Dr. Uretsky’s efforts will again ensure thatunrestricted educational grant support will result ina premier educational event for all attendees. Dr.Uretsky, thank you!

FOR MORE INFORMATION:See www.scai.org for the complete program and registration form online, or call 1 (800) 992-7224.

Seattle Program Committee:

Mark Reisman, MD, FSCAISeattle Program Committee ChairSwedish Medical Center, Seattle, WA

Larry S. Dean, MD, FSCAISeattle Program Committee Co-ChairUniversity of Washington, Seattle, WA

Thomas K. Jones, MD, FSCAISeattle Pediatric Program Committee ChairChildrens' Hospital, Seattle, WA

David A. Clark, MD, FSCAISCA&I Program Committee ChairMonterey, CA

Ted E. Feldman, MD, FSCAISatellite Symposia Evanston Hospital, Evanston, IL

Warren K. Laskey, MD, FSCAIMelvin P. Judkins Symposium ChairUniversity of Maryland Hospital, Baltimore, MD

Barry F. Uretsky, MD, FSCAISponsorship SupportThe University of Texas Medical Branch, Galveston, TX

A World Class Program. . . continued from previous page

Joseph D. Babb, M.D., FSCAIPresident

Consider these sobering realities:

� In some states, regulators with no medicalexpertise have written into law policies regard-ing who can practice in cardiac cath labs, andwho cannot;

� Between 1998 to 2002, Medicare-allowedcharges for interventional procedures will havedeclined by an astonishing 23%;

� Regulators are developing privileging criteria,training standards and credentialing rules ininterventional cardiology;

� SCA&I and ACC surveys of U.S. membersidentify declining reimbursement—and itsnegative impact on patient care—as their single greatest concern.

The bad news—these problems threaten toworsen in the future. The good news—we can domuch if we speak with a strong, unified voice.

Why do we need to respond? After all, hasn’tACC done a satisfactory job representing all cardiolo-gists, including invasive/interventional cardiologists? Ibelieve the answer is a qualified yes.

Federally financed programs are a zero sum pool.If one area (gastroenterology, as a hypothetical exam-ple) gains greater reimbursement, other areas (e.g.,cardiology) must give up an offsetting amount to keepthe total pool of money the same. Within the houseof cardiology, the zero sum game is not as preciselyplayed out, but it does have a significant impact. Ifreimbursement in cardiology is reduced in a givenyear, there are immediate pressures to reduce interven-tional cardiology reimbursement.

ACC recognized this when it created theCardiovascular Relative Value Update Committee(CV RUC), representing all cardiovascular subspecialtyareas. The CV RUC resolves situations that might put subspecialties in conflict. As your representative, I can state that the concept is good and the effortshave been substantial thanks to excellent leadership by the College.

However, there remains the concern that we as asubspecialty cannot be sufficiently represented unlesswe have our own advocate, solely devoted to expressing

4

the voice of invasive/interventional cardiologists. This is the role SCA&I now aggressively pursues.

FIRST, we formed a new Advocacy andGovernment Relations Committee. Chaired byImmediate Past President Carl Tommaso, theCommittee coordinates all SCA&I advocacy activities.Its mission: to ensure that SCA&I members have astrong, independent voice advocating on their behalf.

SECOND, we set advocacy priorities and anaction plan. Priority areas for the coming year:

1. Advocating for fair reimbursement. All inva-sive cardiovascular CPT codes are up for Medicarereimbursement review in 2002. ACC and the AMAplay major roles in making reimbursement recommen-dations to the Centers for Medicare and MedicaidServices. Thanks to Carl and his committee’s efforts,we are now working with ACC as an equal partner indeveloping those recommendations.

2. Dealing with “hot spot” issues. Frequently,issues emerge in one state with potential to influenceother states. A revitalized Governors Network will becritical in dealing with those issues.

3. FDA and NRC device approval issues.Federal processes for approving relevant newdrugs/devices dramatically affect interventional cardiology. We must express our views regarding thosemost critical to high-quality patient care.

4. Introducing SCA&I to key players inCongress and the Executive Branch. Policymakersneed to be aware that SCA&I is the voice of theinvasive/interventional cardiologist.

THIRD, to help us turn these plans into reality,SCA&I has retained MARC Associates of Washington,DC to provide advocacy services. MARC is highlyexperienced in representing medical societies.

SCA&I’s new advocacy capability is an importantnew membership benefit. There is much you can do tohelp make SCA&I’s advocacy voice a powerful one:

� Tell a friend to apply for membership. Themore members, the stronger our voice.

� When you receive an e-mail survey fromSCA&I, please respond quickly.

� Become involved in our grassroots network,our “eyes and ears.”

� Make it your 2002 goal to meet personally onepolicymaker in your state.

Together, we are making a difference!

President’s Message

5

Morton J. Kern, M.D., FSCAI

When discussing what SCA&Ican do for interventional cardi-ologists, I’m frequently asked,“What’s in it for me?” We allknow that in times of econom-

ic stress and decreasing reimbursement any actionson behalf of physicians would be a welcome reliefand a positive step toward better practice and caredelivery. One of the most powerful aspects of joiningSCA&I is to put weight behind your complaints andforce to your voice about government reimburse-ment policies. In response, SCA&I has initiated anaggressive advocacy program to lobby Congress onthese important issues affecting all of us.

However, without a substantial membershipour voice is at risk of being thin and high pitched.To increase its force and impact, we need more par-ticipation and members. By adding your name andencouraging your colleagues to join, we can send astrong message to pressure those agencies targetingreimbursement cuts to cardiologists.

The good news: SCA&I is having a growthspurt. Our membership increased by 17% in 2001,and 2002 is starting off strong as well. The betternews: the more members we have, the louderSCA&I’s voice. Working together, we can doublethat growth in 2002. Remember: SCA&I is theprofessional society devoted solely to the interests ofinvasive and interventional cardiologists.

An example: the “Medicare Physician PaymentFairness Act,” H.R. 3351. This bill, a companion tolegislation introduced in the Senate (S. 1707) wasintroduced in the House of Representatives on Nov.27, 2001, designed to minimize drastic cuts in thefees Medicare pays to physicians. That House legisla-tion was introduced by Reps. Billy Tauzin, R-La.,John Dingell, D-Mich., Michael Bilirakis, R-Fla.,and Sherrod Brown, D-Ohio.

The "Medicare Physician Payment FairnessAct" would have stopped the across-the-boardreduction in physician fees scheduled to go intoeffect in 2002. While this legislation was not considered a permanent fix, it was an importantstart. Unfortunately, in spite of extensive bipartisansupport (and hard work from SCA&I, ACC andothers), the bill did not pass. As a result, the newyear begins with cardiology fees dropping 8.4% on

Editor’s Page

average. Cuts will be more drastic for some cardiovas-cular subspecialists, depending on their mix of services.

This year, our work begins anew. SCA&I isworking closely with the ACC and with other associations to secure passage of comparable legislation in 2002.

To secure passage of such legislation, 51cosponsors of a bill in the Senate and 218 in theHouse will be needed. If a majority of lawmakers ineither body demonstrates their support by cospon-soring such a bill, then congressional leaders mayconsider this to be "must-do" legislation.

A list of cosponsors in the House and Senatewill be sent to SCA&I members via the monthly eNews. This list will be updated regularly. If you are aconstituent of any of these officials, you are encour-aged to communicate your appreciation of their support. If you don’t see the names of your Senators orRepresentative, you need to contact them right away.

SCA&I encourages you to contact your congressional lawmakers with personalized letters at: http://www.senate.gov/senators/senator_by_state.cfmand http://www.house.gov/house/ MemberWWW.html.

What more can we as a Society do for eachother? Lobby for legislative needs, educate our colleagues, and improve patient care throughadvancing technology. In other words, let’s make itour goal for 2002 to expand SCA&I into an evengreater force for change in our professional lives and the lives of our patients.

SCA&I’s CAREER CENTER

www.scai.org

Check out the latest position openings at

Looking for a Change?

6

Redesigned SCA&I Website launched. If you haven’tlooked at www.scai.org recently, do so today. SCA&I’swebsite has been completely redesigned to make it easier to use and provide important new members-onlybenefits. New features:

� An online job bank, where you can postopenings or look for new opportunities;

� Online registration for SCA&I’s 25thAnnual Scientific Sessions in Seattle;

� An online SCA&I membership directory;� Listserves and other features for SCA&I

committees;� Online membership renewal/dues

payment features;� An online membership application;� Discounted member rates for ordering

SCA&I publications;� An “electronic exhibit hall” with links to

companies in the medical industry; and� Updates on important advocacy issues

affecting your practices.Thanks go to Bonnie Weiner, M.D., FSCAI

(Registry & Information Committee Chair) andRick Henegar (SCA&I webmaster) for their effortsto produce the new site. Take a look at the NEWwww.scai.org today!

International meetings. SCA&I membersand others internationally are enhancing theimage and presence of SCA&I. We are fortunateto have them and hope their colleagues also joinSCA&I. Thanks to their efforts, SCA&I has beenactive at recent international meetings. Dr. XavierEscudero, immediate past president of SOCIME(The Society for Interventional Cardiology ofMexico) invited our participation at their recentmeeting in Cozumel. SCA&I President Babb alsospoke with the President of SOLACI (The LatinAmerican Society for Interventional Cardiology),Dr. Expedito Ribeiro, about strengthening tieswith that large and important organization.SCA&I Trustee Dr. J.J. Adolfo Cosentino, Chairof the annual meeting Scientific Committee ofCACI (The Argentine College for InterventionalCardiology) arranged for a special SCA&ISymposium at their recent session (see nextstory). Several Argentine members of SCA&Ispoke at the conference and identified themselvesas SCA&I Fellows (FSCAI).

Report from Argentina. SCA&I Trustee J. J.Adolfo Cosentino, M.D., FSCAI reports that theDecember 2001 XI International Symposium of theArgentine College of Cardiovascular Interventions(CACI) was very successful. The meeting was held inBariloche, Province of Rio Negro, Argentina. SCA&Iwas honored that this meeting was in conjunctionbetween CACI and SCA&I, with a Society sympo-sium including SCA&I President Babb, Past PresidentHarry Page, M.D., FSCAI, and Luis de la Fuente,M.D., FSCAI, who was the first Argentine Fellow ofSCA&I. Dr. Cosentino reports that “the seminars andpresentations were all of the highest standard and webenefited from the expertise of Drs. Babb, Page and dela Fuente, plus Dr. Sorin J. Brener from the USA, Dr.Christopher Buller, MD, FSCAI from Canada, andCACI’s own excellent Argentine faculty.”

“The physicians who attended were able toenjoy the beautiful Llao-Llao Hotel and its spectac-ular surroundings, the picturesque lake and moun-tains, one of our most famous golf courses, tours andparticipation in an impromptu soccer match. Everyone enjoyed their time. After such a successful andenjoyable Symposium we sincerely hope we will beable to repeat the experience again next year.”

Training Directors Committee Meeting.During the November 2001 AHA meeting inAnaheim, SCA&I President-Elect Dr. Ted Feldmanled a meeting of fifty interventional cardiologytraining directors. This highly productive, substan-tive session was the second in an ongoing seriesorganized by SCA&I.

At the first Training Directors Committeemeeting (March 2001 in Orlando), the TrainingDirectors requested SCA&I to facilitate closer dia-logue with the Accreditation Council for GraduateMedical Education (ACGME). In response, Dr.Feldman arranged for Thomas A. Blackwell, M.D.,Chair of ACGME’s Residency Review Committeefor Internal Medicine, to address the group inAnaheim. Dr. Blackwell focused on ACGME’straining program accreditation standards, require-ments and processes, issues of vital importance bothto accredited programs (currently 82) and thoseseeking accreditation.

Next Training Directors meeting: Wednesday,May 15, 1:30 PM in Seattle, during SCA&I’s 25thAnnual Scientific Sessions.

SCA&I News in Brief: New Web Site, New Task Force, and Much More

maintaining the complete independence of SCA&I.Dr. Zipes reinforced his belief in closer communica-tion and cooperation during a meeting with SCA&I’sBoard in Anaheim.

Are you receiving SCA&I’s monthly eNews?Fully 70% of SCA&I’s members have given us their e-mail addresses! Those members receive a BRIEFmonthly e-mail that updates you about upcoming dead-lines, advocacy “hot button” issues, international notesand much more. Not receiving SCA&I eNews? Sendan e-mail to rhenegar@scai.org Note: we never shareyour e-mail address with outside organizations.

Make your voice heard. Have an issue you’d liketo discuss with SCA&I’s President, Dr. Joe Babb? Sendan e-mail to president@scai.org. Let him know howSCA&I can better serve your needs. He wants to hearfrom you!

7

Core Curricula Slide Library Going Online atwww.scai.org ACGME now requires interventionaltraining programs to offer at least one hour of class-room instruction weekly to interventional fellows,addressing core curricula. Many training directorshave noted that finding the time to prepare a newlecture each week can be difficult, and encouragedSCA&I to provide an instructional resource.

In response, SCA&I has developed an elec-tronic library of slide presentations addressing corecurricula topics. This new resource will be online(in the “members only” section of www.scai.org)early in 2002, available to SCA&I members as anew membership benefit.

SCA&I forms Membership Task Force. SCA&IPresident Babb recently formed a new MembershipGrowth and Enhancement (MGE) Task Force. Goal ofthe Task Force: to increase the value of SCA&I mem-bership and develop a tactical plan for attracting newmembers. SCA&I’s membership roster increased by ahealthy 17% in 2001, but we want to double that pacein 2002. Leading the Task Force is Past PresidentSpencer King, M.D., FSCAI (Chair) and JeffreyMarshall, M.D., FSCAI (Co-Chair). Additional mem-bers of the committee include Drs. Skip Minisi, PhilMaxwell, Peter Ferrehi, Samer Garras, Lloyd Klein andMark Steiner. Sandra Baxter, Ph.D., President ofApplied Research Analysts of McLean, Virginia, is providing research support.

Unlike traditional task forces, this one is movingfast. In its first six weeks, the Task Force (a) quicklyestablished a timeline, (b) conducted intensive researchinvolving several hundred interventionalists and (c)presented preliminary recommendations to the Board.Those recommendations included ways to streamlinethe application process, reach out to interventional fellows, and broaden SCA&I’s appeal to non-memberpracticing interventionalists. Watch for next quarter’snewsletter for an update.

SCA&I/ACC leadership meeting. Leadershipfrom SCA&I and ACC met in Anaheim at therecent AHA meeting. Stressing that equal partnershipin key areas (clinical guidelines, advocacy, educationand others) will best serve the needs of members andtheir patients, Dr. Babb observed that this meetingshould be the first of many. All present concurred that SCA&I’s physical relocation to Heart House hasstrengthened ties between both organizations, while

FROM LEFT SCA&I President Joseph Babb, M.D., ACC CEO ChrisMcEntee, ACC President-Elect Bruce Fye, M.D., ACC PresidentDouglas Zipes, M.D., SCA&I President-Elect Ted Feldman, M.D.

8

SCA&I Launches Cardiac Image Standard (“Phantom”)Benchmark Study

Background. Cardiac angiographers now performmore than two million diagnostic and interventionalprocedures annually in the U.S. No standardizedmethod is available to evaluate performance of radi-ographic equipment used for these procedures. Thanksto years of hard work by several SCA&I members, thatproblem is about to be solved.

Recognizing the need for a cath lab testing system, SCA&I’s Laboratory Performance StandardsCommittee (Chair:Michael Cowley, M.D.,Medical College ofVirginia; Co-Chair, CharlesChambers, M.D., HersheyMedical Center) has advo-cated for a nationally stan-dardized method to evalu-ate image quality and radi-ation dose. SCA&I askedNEMA (National ElectricalManufacturers Association)to form a working group of industry and SCA&Irepresentatives.

Extensive effort resulted in the NEMA XR212000 standard, which describes the construction of a Fluoro Benchmarking Phantom. This Phantomand a standardized testing format are now commer-cially available from Nuclear Associates, Inc. andother sources.

The Phantom is a device used to test systemsunder conditions simulating normal clinical use forfluoroscopically-guided invasive and interventionalprocedures. The Phantom is constructed of Plexiglaswith iodine and aluminum test objects. This materialhas x-ray absorption and scatter properties similar tohuman soft tissue. Configuring the Phantom simu-lates the entire range of patient sizes and imagingprojection angles.

To obtain consistent data collection for aBenchmark Study, the Laboratory PerformanceStandards Committee has arranged for training of thoseparticipating in the study, to be provided by ClarteImaging Solutions, Inc., (1-866-620-7828) of Elk

Phantom Benchmark Study

continued on page 15

Grove CA. This organization, an independentprovider of image quality assessment, will also be a primary provider of testing services.

Benchmark study. SCA&I seeks participantsfor the Benchmark Study, who wish to utilize theNEMA/SCA&I Phantom testing system to evaluateand compare performance of their adult cardiac cathlabs. The Study’s goal is to collect data that willenable each lab to compare image quality and radiation dose to:

� trends of a single lab over time; � other labs in the same institution; and� labs in other institutions.

Application of thistesting system should eventually result in: � early recognition of deteriorating acquisition & display equipment;� improved image quality; � reduced radiation expo-sure to the patient andangiographer; and � standardized image quality for labs involved in multicenter studies.

For the BenchmarkStudy, a data set has been

devised that will answer the following questions:� How good are the major image quality char-

acteristics in a laboratory? � How do Phantom measurements of image qual-

ity compare to subjective clinical estimation ofimage quality?

� What is the radiation dosage needed to achievethe observed level of performance?

SCA&I will maintain a Benchmarking StudyRegistry, to collect, organize and report test resultsfrom each institution in a confidential manner tothat institution only, supervised by the SCA&ILaboratory Performance Standards Committee.Each participating institution will receive its ownresults and the pooled (not individualized) resultsof all participants for comparison.

Tests. The basic tests of the NEMA/SCA&I testing system include: spatial resolution; low contrastdetectability; working thickness range; temporal resolution; and entrance exposure rates.

FROM LEFT Merrill Wondrow and Marv Alley demonstratingPhantom to SCA&I President Joseph Babb, M.D.

continued on page 12

9

Important Information from Industry Sponsors

SCA&I greatly appreciates the generous unrestricted edu-cational grant support provided by many industry sponsors.This sponsorship makes possible high quality educationalprograms such as SCA&I’s Annual Scientific Sessions.The following has been provided for your information byseveral of those sponsors; the content below is solely theirown, and does not represent the viewpoint of SCA&I.Please contact these firms directly for further information.

Unrestricted Educational GrantSponsorship for Seattle Meeting

Thanks to the tireless efforts of Barry F.Uretsky, M.D., FSCAI and the FundraisingCommittee, educational grants from many industrypartners will again ensure that SCA&I’s AnnualScientific Sessions provides the highest quality edu-cational venue anywhere. As of press time, generoussupport has been committed by the following firms:

� Trustee Level: Guidant Corporation� President Level: Boston Scientific; Cordis

Endovascular/Cordis Cardiology� Sustainer Level: Bristol-Myers

Squibb/Sanofi Pharmaceuticals Partnership;Millennium Pharmaceuticals, Inc. and KeyPharmaceuticals, Inc.; Philips Medical Systems

� Achiever Level: Amersham Health; Eli LillyCorporation; Kensey Nash Corporation;Medtronic/AVE

� Supporter Level: Pharmacia Corporation;John Wiley &Sons, Inc.

� Friends Level: Ceres Medical Systems

Boston Scientific

Boston Scientific Corporation (NYSE:BSX) isthe world's largest medical device company dedicatedto less-invasive therapies. The company's productsand technologies reduce risk, trauma, cost, proce-dure time and the need for aftercare.

These products and technologies are generallyused for enlarging narrowed blood vessels to preventheart attack and stroke, clearing passages blocked byplaque to alleviate pain, opening obstructions andbringing relief to patients suffering from variousforms of cancer, conducting biopsies and ultrasounds,treating renal disease, mapping electrical problems inthe heart, treating gastrointestinal disease, placingfilters to prevent blood clots from reaching thelungs, and treating brain aneurysms. These less-inva-sive therapies result in improved outcomes, whichhelp patients return to fuller lives sooner.

For more information, visit Boston Scientific atwww.bsci.com

Cordis Endovascular

Cordis Endovascular is a global leader in thedevelopment and marketing of medical devices suchas stents, angioplasty balloons, guidewires, diagnos-tic catheters, sheaths and vena cava filters for thetreatment of vascular and obstructive diseases.

Cordis Endovascular markets a full line ofstents in a variety of lengths and diameters. Ourself-expanding stents include the S.M.A.R.T.‰Transhepatic Biliary Stent with MicroMarker‰Technology and the new PRECISE‰ TranshepaticBiliary Stent. The PRECISE‰ Stent offers a lowprofile 5.5F delivery system through an .018”guidewire designed to reduce patient trauma.

The newest stent introduced to the balloon-expandable market from Cordis Endovascular is thePALMAZ‚ GENESIS‰ Transhepatic Biliary Stent.This stent is available in two configurations – as apre-mounted stent on three new balloon catheters,as well as unmounted. Additionally, Cordis offers thePALMAZ‚ Stent in expansion sizes of 6-8mm andlengths 10-30mm on OPTA‰ LP and POWER-FLEX‚ PLUS balloon-expandable sizes for iliac use.

PTA Dilatation Catheters are also available in avariety of sizes with low profile design attributes andthe strength of the versatile DURALYN‚ material.

Seattle Program Committee Chair Mark Reisman, M.D., FSCAIreceiving a generous unrestricted educational grant from DavidBian, Guidant Corporation Regional Sales Manager

10

SCA&I Advocacy Update

SCA&I’s new advocacy program is off to an aggressive start, led by the Advocacy Committee(chaired by Carl L. Tommaso, M.D., FSCAI) and supported by MARC Associates, our newWashington advocacy representatives. SCA&I isworking closely with ACC and other societieswhere appropriate – and taking the lead in reim-bursement issues relevant to invasive/interventionalcardiology. Recent highlights:

Practice Expenses reviewed: AMA’s PracticeExpense Advisory Committee (PEAC) is looking atthe clinical practice expenses for interventionalcodes. This is an important “bread and butter” issuewhere SCA&I membership involvement canincrease the potential for fairer Medicare reimburse-ment. SCA&I organized a consensus panel of twentySCA&I members at the November American HeartAssociation meeting, reinforced by subsequent mem-bership e-mail surveys. These data were vital in help-ing SCA&I develop realistic, defensible estimates ofthe clinical (non-M.D.) staff time needed to provideleft heart cath and other diagnostic services.

Some background: As you know, Medicarepayments consist of an allowance for physicianwork, an allowance for physician practice expenseand an allowance for physician liability insurance.Currently, there are no direct practice expensesassigned to the catheterization procedures, CPTCodes 93508-93533, when these services are per-formed in a hospital setting. Direct costs includesuch expenses as clinical staff time, equipment andsupplies provided by office personnel. Indirect costssuch as office overhead and billing costs are assignedbased on a formula approach.

SCA&I recently made a presentation to thePractice Expense Advisory Committee (PEAC), amulti-specialty advisory committee that providesrecommendations to CMS (formerly HCFA) onpractice expense values. We identified clinical staffactivities provided by office staff to support acatheterization procedure in a hospital setting.These include such tasks as obtaining consent,explaining the procedure to the patient and familyand scheduling the cath lab and equipment. Whilewe are prohibited by a confidentiality agreementfrom publicizing the specific results of the PEACmeeting, we are optimistic that this will lead to anincrease in payments for catheterization procedures

continued on page 15

(perhaps as soon as early next year). We will adviseyou further when CMS publishes their final ruling.

Interventional Cardiologist to Join NRCPanel: In an important win for SCA&I members, the Nuclear Regulatory Commission (NRC) agreedto our persistent urging that NRC add a voting inter-ventional cardiologist to the NRC AdvisoryCommittee on the Medical Uses of Isotopes(ACMUI). The ACMUI has a major say in deter-mining which medical specialties are allowed toadminister intravascular radiation therapy for preven-tion of in-stent restenosis (aka brachytherapy). JeffreyBrinker, M.D., FSCAI (Johns Hopkins) is SCA&Inominee (ACC has endorsed this nomination).

Medicare Fee Schedule Cuts Challenged:Despite a massive lobbying effort involving theAMA, SCA&I and 60 other medical societies,Medicare payments for U.S. physicians' servicesdropped 5.4% on January 1, 2002. Payments for cardiologists dropped even more (8.4%) because ofother changes in the cardiology relative values forthe fee schedule. Legislation was introduced (S.1707 and H.R. 3351) that would have limited thedrop in payment to 0.9%. In 2002 SCA&I will continue to work with the AMA, ACC and a broadcoalition of health professions organizations to tryto persuade Congress to act quickly to lift the cutthis year. Thank you to the many SCA&I memberswho responded to our e-mailed "action alert" bywriting or calling their Senators and Representatives.Your letters and call do make a difference! Many ofyour Senators and Representatives cosponsored thelegislation to restore the cut in the conversion factor.

SCA&I Meets with Centers for Medicareand Medicaid Services (CMS): On September 25,SCA&I President Joseph Babb joined colleaguesfrom ACC, the Society of Thoracic Surgeons andthe American Academy of Orthopedic Surgeons ina meeting with CMS chief Tom Scully to discussMedicare’s Centers of Excellence Program. Thisexperimental program arguably is more about pricethan excellence. It designates certain hospitals as“Centers of Excellence” when they agree to com-bine and discount the hospital fee and the physicianfee for selected procedures. SCA&I and the othergroups sought a change in the name, whichCommissioner Scully granted, and the opportunityto work with CMS to develop meaningful quality

11

incidence of death and nonfatal reinfarction by 17percent, the need for percutaneous revascularizationby 12 percent and the combination of death/rein-farction/per-cutaneous revascularization by 25 per-cent. The incidence of any ischemic complica-tionat seven days was reduced from 31.7 percent in thereteplase group to 28.6 percent in the combinationgroup. However, it should also be made clear thatthe trial was not blinded – the investigators knewwho got which therapy – and these same physicianswere the sole adjudicators of the MI endpoint.Reinfarction was defined by ST changes and enzymelevels rather than a clinical definition. In fact, theincidence of Q wave reinfarction was <0.5% in bothgroups, again raising the question of the importanceof preventing minor CK elevations.

Severe bleeding was more common in thegroup receiving the combination therapy (1.1 vs.0.5 percent), as was the overall risk of bleeding(13.7% vs. 24.6%, p=0.001). The need for transfu-sion was also increased (4.0% vs. 5.7%, p<0.001).There was increased intracranial bleeding in theelderly (age >75) in the combination therapy group(1.1% vs. 2.1%, p=0.033 for interaction with age).Most of the excess bleeding in the combinationgroup was in the form of non-life-threateningbleeds. Procedure-related bleeding was not signifi-cantly different between the two groups. Thus, thecombination regimen may be especially valuable inpatients who will proceed to the catheterization lab-oratory, since GPIIb/IIIa blockers have proven bene-fit in this setting.

Patients younger than 75 years, those with ante-rior infarcts and those treated after four hours allshowed trends toward greater benefit from the combi-nation. As such, the new strategy seems best suited toyounger patients with large MIs, for whom the com-bination can be considered advantageous. However,elderly patients over age 75 with large MIs may alsobe considered because the reduction of reinfarctionwas largest in this subgroup. However, where 12 rein-farctions are prevented per 100 patients treated, thiscomes at a cost of nearly 100 bleeds.

Much has been made of the finding that therewas an unusually low 30-day mortality rate in bothgroups compared to previous trials. Undoubtedly,this factor played a role in the disappointing resultsobserved in regard to the primary outcome.

GUSTO V (Lancet 2001; 357:1905-1914)

by Lloyd W. Klein, M.D., FSCAIProfessor of Medicine, Rush Heart Institute, Chicago IL

Thrombolytic therapy for acute myocardialinfarction (MI) has been limited by its lack ofachieving rapid, sustained and complete vesselpatency in over 20% of patients. The GUSTO Vtrial is the first large-scale study in which the com-bination of a GPIIb/IIIa inhibitor (abciximab) witha reduced dose of fibrinolytic agent (reteplase) hasbeen evaluated for the treatment of patients withMI. The study enrolled 16,588 patients with ST ele-vation MI who were randomized within six hours ofsymptom onset. All patients were treated withaspirin and then treated with either heparin (5000 ubolus + 1500 u/hr) and standard dose (two 10 uboluses, 30 minutes apart) reteplase or weight--adjusted heparin and half dose (two 5 u boluses, 30minutes apart) reteplase plus a full dose of abcix-imab (0.25mg/kg bolus and 0.125mg/kg/min. infu-sion up to 10 ig/min. for 12 hours).

The new combination of rete-plase and theGPIIb/IIIa inhibitor abciximab failed to improve 30-day mortality - the primary endpoint of thestudy. Death at 30 days was 5.9 percent in the groupthat received full-dose reteplase and 5.6 percent inthe group that received reduced-dose reteplase plusabciximab (OR 0.95, CI 0.83, 1.08, p=0.43). Whilecombination therapy was not superior to reteplasealone, it was also not inferior. This somewhat con-ceptual conclusion occurred because, statistically, apenalty was paid for multiple interim analyses forthe test of superiority – the required p value wasmade more stringent (p<0.025). However, no penal-ty was required for the non-inferiority analysis.Additionally, most major nonfatal ischemic compli-cations were significantly reduced with the combi-nation compared with the standard regimen. Therewas a 33 percent reduction in re-infarction at sevendays with the combination regimen, and in previoustrials, reinfarction at seven days is often a significantpredictor of mortality at one year.

Several composite endpoints were reduced inthe combination therapy arm, but these were notpre-specified endpoints. The reteplase/abciximabcombination significantly reduced the seven-day

Hot Topics in Interventional Cardiology

continued on next page

12

Hot Topics in Interventional Cardiology...continued from previous page

Industry Sponsors...continued from page 9

However, it should also be recognized that this wasa lower risk population than in previous throm-bolytic therapy trials – there were fewer anteriorwall MIs, and patients with a single elevated bloodpressure were excluded.

The authors conclude by asking whether com-bination therapy should be incorporated into clini-cal practice on the basis of this trial. Their answer isthat it depends on cost, because while this studyshows fewer complications and reinfarction, thesmall net incremental benefit requires both clinicaland economic judgments. Additionally, the one-

year outcome data, when available, may also pro-vide further information. Nevertheless, the conceptof a combination regimen as reflected by theimprovement in some outcomes seems to be sound,but the results are disappointing in that it alsoincreased bleeding complications. Perhaps furtherstudies evaluating the correct dosing combination,and maybe other agents, will provide the real break-through. For example, the results of ASSENT-3,combining enoxaparin, ReoPro and tenecteplase,will also be relevant to the final denouement, par-ticularly in the elderly.

The .035” diameter balloons include the OPTA‰PRO, POWERFLEX‚ P3, POWERFLEX‚EXTREME‰ and MAXI‰LD. The .018” diameterballoons include SAVVY‰ and the new SLALOM‰.

Diagnostic catheters are available in a varietyof types, lengths and French sizes. They include the TEMPO‚, NYLEX‰ SUPERTORQUE‚ andSUPERTORQUE‚ MB Catheters. Guiding cathetersare available in a variety of shapes, lengths andFrench sizes. They include the VISTA BRITE TIP‚and the VISTA BRITE TIP‚ IG Catheters.

Cordis Endovascular recently launched theTRAPEASE‰ Permanent Vena Cava Filter to its Thrombus Management line of products.Included in that line is the HYDROLYSER‰Thrombectomy Catheter used for the removal ofthrombus in dialysis grafts.

The STORQ‚, SV, JINDO‰ and EMER-ALD‰ Guidewire product line is obtainable in var-ious lengths, diameters, tip shapes (straight, angled,double-ended and J-shaped) and tip flexibilities(standard, soft and supersoft).

Cordis Sheath Introducers are available in vari-ous French sizes and cannula lengths and includethe BRITE TIP‚ and AVANTI‚+.

Cordis Endovascular’s focus has always been onits customers and ensuring that their clinical and

productivity needs are understood. Equally impor-tant to Cordis Endovasclar is the ability to delivernew products and technologies that are specificallycalibrated to work together to complement inter-ventional skills and maximize performance.

Medtronic AVE

Medtronic AVE is the Vascular Division ofMedtronic, Inc., the world’s leading medical technolo-gy company, providing lifelong solutions for peoplewith chronic disease.

Medtronic AVE designs, engineers and manufac-tures innovative technologies for coronary, peripheraland neurovascular indications. Medtronic AVE isknown for its passion and drive to deliver productsthat are easy to use, safe and effective. Recentadvancements include:

� The S7 with Discrete Technology™ CoronaryStent System, featuring Medtronic AVE’sunique modular stent design, with enhanceddeliverability plus unmatched scaffolding.

� The GuardWire Plus Temporary Occlusion &Aspiration System, which facilitates distal pro-tection by preventing particulate debris frommoving distally. This simple, elegant solution

continued on page 15

addresses specific payment problems that may requirechanges in coding and claims processing and relativevalue adjustments or other technical solutions.

MARC Associates’ Principals: RandolphFenninger, President, has 30 years of legal and leg-islative expertise in health care legislative and regu-latory issues. His background includes work withthe AMA and numerous specialty societies. He hasextensive experience representing clients before theHouse Ways and Means and Senate FinanceCommittees. Bernard Patashnik joined the firmafter a distinguished career at the Health CareFinancing Administration and the Social SecurityAdministration. He advises clients on a wide spec-trum of health care financing issues and managesstrategies seeking coverage and improved paymentfor a range of products and provider services.

standards and measures (also granted). This was an important step in getting concerns ofinvasive/interventional cardiologists at the top levels of CMS’s radar screen.

A Note About MARC Associates. MARCAssociates, Inc., a Washington, DC-based govern-ment relations firm, represents corporate and non-profit associations. MARC is bipartisan firm withstrong working relationships with House and Senateleadership and key Committee Members, togetherwith top Administration, Departmental and regula-tory officials. MARC provides legislative and regula-tory advocacy and expertise in health economics,finance and administration. The firm’s health carework covers product and provider payment coverage,drug and device approval, health care system reformand coverage for chronic diseases. MARC also

15

SCA&I Advocacy Update... continued from page 10

Phantom Benchmark Study... continued from page 8

Study Participation. Study participants mayobtain from SCA&I information about how to pur-chase a Phantom and services from an approved testingservice. Data will be forwarded to the Registry, and hos-pital technical personnel will be trained on-site by thetesting service. This provides the opportunity for thedepartment to perform subsequent testing independent-ly with no major additional service or hardware costs.

Special thanks go to Frederick Heupler, M.D.,FSCAI, who prepared much of the background for this

article, and to Charles Chambers, M.D., FSCAI, who is spearheading the SCA&I Phantom effort. OtherSCA&I members key to this project: Stephen Balter,Ph.D., Michael Cowley, M.D., FSCAI, Warren Laskey,M.D., FSCAI, Merrill Wondrow, and David Holmes,M.D., FSCAI

To sign up for the study or for more information, contact Norm Linsky, SCA&I Executive Director, at 1 (800) 992-7224.

Industry Sponsors...continued from page 12

has been clinically proven to reduce cumula-tive MACE rates by 42 percent.

� The AneuRx® Stent Graft System forendovascular repair of abdominal aorticaneurysms. This easy-to-use system offers a lowprofile and superb delivery for controlled, accu-rate placement.

� The Bridge SE Self-Expanding PeripheralStent for Biliary Indication, featuring an

advanced laser-cut stent design made of crush-resistant Nitinol for high radial strength andresistance to compression.

For more information about these and other innovative vascular solutions from Medtronic AVE, visitwww.MedtronicAVE.com or contact your local sales rep-resentative.