B Y R O B I N S E AT O N

J E F F E R S O N

Else vier Global Medical Ne ws

S T. L O U I S — A review of 250consecutive patients who un-derwent bilateral lung volumereduction surgery for emphyse-ma showed improvement in res-piratory mechanics associatedwith reduction in hyperinflation,producing significant palliativebenefit for patients, according toDr. Joel D. Cooper at a thoracicsurgery meeting sponsored byWashington University.

Dr. Cooper reported that the90-day and complete hospitalmortality was 4% in the series ofpatients treated at Barnes-JewishHospital in St. Louis betweenJanuary 1993 and June 2000.There were no intraoperativedeaths. Follow-up ranged from2 years to 9 years, with a medi-

an of 4 years. Only one patientwas lost to follow-up; 96 of the250 patients died, most of themfrom respiratory failure.

The forced expiratory volumein 1 second (FEV1) and the resid-ual volume (RV) “showed a sta-tistically significant improve-ment between preoperativevalues and each time point offollow-up. There was no statisti-cal significance between initialevaluation and postrehabilitation

FEV1 and RV,” he said. The re-sults from gas exchange and oxy-gen showed a mean oxygen pres-sure (PaO2) increase of 8 mmHg at the 6-month, 1-year, and 3-year follow-ups and of 5 mm Hgat 5 years. Also, 79% of patientshad improved at 3 years and 66%at 5 years, he said.

Dr. Cooper said supplementaloxygen requirements at rest de-

T H E O F F I C I A L N E W S P A P E R O F T H E A M E R I C A N A S S O C I A T I O N F O R T H O R A C I C S U R G E R Y

VOL. 2 • NO. 2 • MARCH/APRIL 2006

Lung VolumeReduction Surgery

Benefits BODE

B Y B R U C E K . D I X O N

Else vier Global Medical Ne ws

M O N T R E A L — Lung volumereduction surgery improves theBODE index, a composite prog-nostic model that denotes dis-ease severity in patients withchronic obstructive pulmonarydisease, as shown by a smallstudy presented at the annualmeeting of the American Col-lege of Chest Physicians.

This means that changes inthe BODE (body mass index,airflow obstruction, dyspnea,and exercise capacity) indexmight be promising as markersfor predicting surgical out-come in chronic obstructivepulmonary disease (COPD)patients, according to Dr.David J. Lederer of NewYork–Presbyterian Hospital inNew York.

If the appropriate factors thatpredict change in the BODE in-dex could be identified, in thefuture, measurements might bedone on a patient to determineif surgery was appropriate

based upon BODE, Dr. Leder-er said in an interview. “That re-search is two or three studiesaway and we have to [first] seethat changes in BODE predictoutcomes, and then we have tofind the baseline characteristicsthat predict the change inBODE.”

This approach is an out-growth of the National Em-physema Treatment Trial(NETT), which found that lungvolume reduction surgery(LVRS) improved survival, aswell as exercise capacity andquality of life in a subset of pa-tients who have severe emphy-sema.

The data showed that:� Participants with mostly up-per-lobe emphysema and lowexercise capacity were morelikely to live longer and morelikely to function better afterLVRS than after medical treat-ment. � Those with mostly upper-lobe emphysema and high ex-

Endovascular Skills AreBecoming Essential

B Y B R U C E K . D I X O N

Else vier Global Medical Ne ws

C H I C A G O — P ercutaneous in-terventions continue to replaceconventional surgical repair, andthe future for cardiothoracic sur-geons lies in catheter-based train-ing and intervention, said Dr.Tomas A. Salerno at the annualmeeting of the Society of Tho-racic Surgeons.

His remarks echo those by Dr.Grayson H. Wheatley III, whosaid that if cardiothoracic sur-geons don’t learn interventionalskills, those skills would be lost toother specialties that already havethe upper hand.

Procedures such as patent duc-tus, coarctation, atrial septal defectand various congenital defects,peripheral vascular surgery, and

pacemakers have slipped betweenthe fingers of cardiothoracic sur-geons “just because of our lack ofcatheter and interventional skills,”said Dr. Wheatley, a cardiovascu-lar surgeon with the ArizonaHeart Institute in Phoenix.

“For cardiac surgeons, en-dovascular skills represent ‘theroad less traveled,’” he said. “Justimagine if, early on, we had in-corporated endovascular skillsinto our practices and in thetraining programs of cardiacsurgery residents; I think endo-luminal stenting would now bean integral part of most of ourcardiothoracic practices, and wewould be doing a whole lot ofstenting throughout the body.”

The situation is compounded

CO

UR

TE

SY

DR

. T

OM

AS

A.

SA

LE

RN

O

Dr. Tomas A. Salerno moderated a symposium on the key role ofstenting held at the Society of Thoracic Surgeons annual meeting.

LVRS for Emphysema Shows Promise

See LVRS • page 7

News

Residents’ EvilSTS panel discusses finding

graduates the right jobs. • 3

At OddsSurgeons think the quality of

teamwork in the OR is good,

but other staff disagree. • 6

Congenital Heart

Migraine BlockerSome migraine patients may

benefit from closure of their

patent foramen ovale. • 1 1

Adult Cardiac

Guideline Hitch Aortic diameter is not always

the best predictor of the risk

of dissection. • 1 6

Devices & Trials

Kids’ StuffDefining the regulatory

process for pediatric

devices. • 1 8

I N S I D E

See Essential Skills • page 6

Index may be marker for improvement.

Presorted StandardU.S. Postage

PAIDPermit No. 384Lebanon Jct. KY

THORACIC SURGERY NEWS

12230 Wilkins AvenueRockville, MD 20852CHANGE SERVICE REQUESTED

See Emphysema • page 9

Men Still Outnumber Women in Thoracic Surgery

16167

1,106

1,438

1,183

856

69 62 17 2

Note: Based on 4,750 male thoracic surgeons and 166 female thoracicsurgeons in the United States in 2004.Source: American Medical Association

Women

Men

�65 years55-64years

45-54years

35-44years

<35 years

V I T A L S I G N S

RIC

HA

RD

FR

AN

KI/E

LS

EV

IER

GL

OB

AL

ME

DIC

AL

NE

WS

MARCH/APRIL 2006 • T H O R AC I C S U R G E R Y N E W S NEWS 3

THORACIC SURGERY NEWSAMERICAN ASSOCIATION FOR THORACIC SURGERY

Editor Joel D. Cooper, M.D.

Associate Editor, General Thoracic

Yolonda L. Colson, M.D., Ph.D.

Associate Editor, Adult Cardiac

Carlos M.G. Duran, M.D., Ph.D.

Associate Editor, Cardiopulmonary Transplant O. Howard Frazier, M.D.

Associate Editor, Congenital Heart William G. Williams, M.D.

Executive Director Robert P. Jones Jr., Ed.D.

Director of Administration Cindy VerColen

THORACIC SURGERY NEWS is the official newspaper of the American Associationfor Thoracic Surgery and provides the thoracic surgeon with timely andrelevant news and commentary about clinical developments and aboutthe impact of health care policy on the profession and on surgical practicetoday. Content for THORACIC SURGERY NEWS is provided by the ElsevierSociety News Group and Elsevier Global Medical News. Content for theNews From the Association is provided by the American Association forThoracic Surgery.

The ideas and opinions expressed in THORACIC SURGERY NEWS do notnecessarily reflect those of the Association or the Publisher. The AmericanAssociation for Thoracic Surgery and Elsevier Inc. will not assumeresponsibility for damages, loss, or claims of any kind arising from orrelated to the information contained in this publication, including anyclaims related to the products, drugs, or services mentioned herein.

POSTMASTER: Send changes of address (with old mailing label) toCirculation, THORACIC SURGERY NEWS, 12230 Wilkins Ave., Rockville,MD 20852.

The American Association for Thoracic Surgery headquarters is locatedat 900 Cummings Center, Suite 221-U, Beverly, MA 01915.

THORACIC SURGERY NEWS (ISSN 1558-0156) is published bimonthly for theAmerican Association for Thoracic Surgery by Elsevier Inc., 60Columbia Rd., Bldg. B, Morristown, NJ 07960, 973-290-8200, fax973-290-8250.

ELSEVIER SOCIETY NEWS GROUP

President, IMNG Alan J. Imhoff

Director, ESNG Mark Branca

Executive Director, Editorial Mary Jo M. DalesExecutive Editor, IMNG Denise FultonExecutive Editor, EGMN Kathy Scarbeck

Publication Editor Mark S. Lesney

Publication Associate Editor Renée Matthews

VP, Medical Education Sylvia H. Reitman

Senior Director, Marketing and Research Janice Theobald

Executive Director, Operations Jim Chicca

Director, Production and Manufacturing Yvonne Evans

Executive Director, Business Operations Bari Edwards

Production Manager Judi Sheffer

Art Director Louise A. Koenig

EDITORIAL OFFICES 12230 Wilkins Ave., Rockville, MD 20852, 301-816-8700, fax 301-816-8738, aats@prri.com

©Copyright 2006, by the American Association for Thoracic Surgery

Display Advertising Manager Steve Everly, 267-893-5686, fax267-893-5682, severly@ki-lipton.com

Classified Sales Manager Robin Cryan, 800-379-8785, fax212-633-3820, r.cryan@elsevier.com

Address Changes Fax change of address (with old mailing label)to 301-816-8736 or e-mail change to subs@elsevier.com

Advertising Offices 60 Columbia Rd., Bldg. B, Morristown, NJ07960, 973-290-8200, fax 973-290-8250

Classified Advertising Offices 360 Park Ave. South, 9th Floor,New York, NY 10010, 800-379-8785

B Y M A R K S. L E S N E Y

Else vier Global Medical Ne ws

C H I C A G O — Lack of quality job oppor-tunities is the primary concern for thoracicsurgery residents, according to exit surveysfrom last year’s Society of Thoracic Sur-geons annual meeting, said Dr. John R.Mehall, president of the Thoracic SurgeryResidents Association.

For this reason, the residents met at this

year’s STS meeting to discuss “Today’s JobMarket: How to Look and What’s in De-mand.”

“The effects of declining cardiac casevolumes, declining reimbursements, and adeclining stock market combined to createa situation where hiring was scarce and re-tirements were postponed,” Dr. Mehallsaid in an interview.

“As a result, many graduating cardio-thoracic residents could not find quality

Employment Remains a Key Issue for Residentspractice opportunities, or in somecases, any opportunities at all,”added Dr. Mehall, who is a cardio-thoracic surgery resident at the Uni-versity of Cincinnati.

To help residents have better in-sight into the job process, a panel ofsurgeons who recently hired newgraduates was assembled to discusswhy they hired new residents, whatthey were looking for, and how theywent about the process. Panel mem-bers included Dr. A. MichaelBorkon, the MidAmerica Heart In-stitute, Kansas City, Mo.; Dr. John H.Calhoon, the University of TexasHealth Science Center, Houston;Dr. W. Randolph Chitwood Jr., EastCarolina University, Greenville,N.C.; Dr. Joseph N. Cunningham,Maimonides Medical Center, Brook-lyn, N.Y.; Dr. Kim F. Duncan, theUniversity of Nebraska MedicalCenter, Omaha; and Dr. Joseph F.Sabik III, the Cleveland Clinic Founda-tion.

In response to tales of unemploymentand underemployment presented by resi-dents in the audience, the panel empha-sized networking to find new jobs, notmerely answering classified ads. Almost allhiring, the panelists agreed, was done onthe basis of recommendations from peo-ple who were known and respected by theemploying surgeon. Specialized trainingwas also emphasized by several of the pan-el members, who pointed out that theytended to hire surgeons to fill specificroles and selected individuals with the de-sired expertise.

There is another reason for the currentpoor job market. According to one pan-elist, the eligible pool not only includesresidents but also midlevel cardiac sur-geons let go for financial reasons in prac-tices across the United States, who arelooking for jobs.

There does appear to be hope for the fu-ture, however, according to Dr. Mehall,echoing the view of many of the panelists.

“The expanding scope of cardiothoracicsurgery into new areas such as arrhythmiasurgery, the reality of a steadily increasingpopulation of aging patients, and an in-crease in retiring surgeons should signifi-cantly improve the overall situation foryoung surgeons,” he said.

“As these trends continue, some areeven predicting a shortage of cardiotho-racic surgeons in 5-10 years. Currently,however, most residents compete in a dif-ficult job market,” Dr. Mehall stated.

The Thoracic Surgery Residents Asso-ciation represents more than 400 residentstraining in programs throughout NorthAmerica. The association has representa-tives working with all major professionalorganizations within thoracic surgery toimprove surgical education and training.In addition to the residents’ luncheon atthe annual STS meeting, TSRA is planninga residents-only Cardiothoracic Technol-ogy Symposium in May, Dr. Mehall said.

For more information, visit www.ctsymposium.org or see page 12 of thisnewspaper. ■

Dr. John R. Mehall is the current president ofthe Thoracic Surgery Residents Association.

CO

UR

TE

SY

DR

. J

OH

NR

. M

EH

AL

L

Panel discussion at the STS annual meeting sees

mixture of hope and gloom in resident hiring.

NEWS • 3

The new SPECT guidelines couldextend beyond quality to includecost-effectiveness and efficiency, 4

GENERAL THORACIC • 7

Adding acetylcysteine to the stan-dard treatment for pulmonary fibro-sis slows its progression, 8Endoscopic ultrasound beats PET instaging lymph nodes, 8

CARDIOPULMONARYTRANSPLANT • 1 0

Cardiac interventions do notincrease lung transplant risks.GERD surgery may lower rejectionrisk rates in lung transplant patients.

CONGENITAL HEART • 11

Pregnancy in women with isolatedcongenital pulmonary valve stenosisis associated with obstetric and fetalcomplications.

ADULT CARDIAC • 1 5

Using NSAIDs in patients who’vehad an acute MI raises the risk ofmortality, says a Danish study.BASKET trial researchers say rou-tine use of drug-eluting stents is notcost effective, 17

DEVICES & TRIALS • 1 8

Development of pediatric circulato-ry support devices could guide theregulatory process of other high-risk pediatric devices, 19

I N T H I S I S S U E

NEWS FROM THE ASSOCIATION • 1 2

The Thoracic Surgery Residents Association plans a symposium for training

in new technologies and minimally invasive techniques.

Some highlights of the upcoming AATS annual meeting in Philadelphia.

4 NEWS T H O R AC I C S U R G E R Y N E W S • MARCH/APRIL 2006

0

2%

4%

6%

8%

10%

Consumer price index

Per capita national health expenditures

2003200220012000199919981997199619951994

Rise in National Health Expenditures Slows

Source: The Henry J. Kaiser Family Foundation

Annual percent change

D A T A W A T C H

KE

VIN

FO

LE

Y/E

LS

EV

IER

GL

OB

AL

ME

DIC

AL

NE

WS

Cultures Fail to Predict PostsurgicalMediastinitis in Heart Patients

WA S H I N G T O N — Sternalwound and mediastinal tissuecultures are not effective predic-tors of postsurgical mediastinitisin heart surgery patients, wroteDr. Emilio Bouza in a poster pre-sented at the annual InterscienceConference on AntimicrobialAgents and Chemotherapy.

Dr. Bouza and his colleaguesat the Hospital General Univer-sitario Gregorio Marañón inMadrid conducted a prospectivestudy of 227 patients undergo-ing 229 sternotomies for heartsurgery in order to assess the va-

lidity of postsurgical cultures inpredicting mediastinitis. Medi-astinitis—defined in this study aspurulent discharge associatedwith either partial or completesternal dehiscence—has been as-sociated with prolonged hospi-tal stays and mortality ratesranging from 6% to 19%.

A total of seven patients de-veloped postsurgical mediastini-tis 11 days after surgery. In thesepatients, five of the semiquanti-tative mediastinal fluid culturesand three of the quantitative cul-tures were sterile, and the re-

maining cultures contained mi-croorganisms different fromthose that caused the infections.In the 220 patients (222 proce-dures) who did not develop post-surgical mediastinitis, 31% ofsemiquantitative mediastinal cul-tures and 34% of quantitativecultures were positive. Conse-quently, the investigators do notrecommend intraoperative cul-tures for heart surgery patients.

The meeting was sponsoredby the American Society for Mi-crobiology.

—Heidi Splete

B Y R O B E R T F I N N

Else vier Global Medical Ne ws

Driven by concerns over the rising costof cardiovascular care and loomingpay-for-performance rules, a techni-

cal panel convened by the American Col-lege of Cardiology Foundation and theAmerican Society of Nuclear Cardiologyhas released the first set of appropriatenesscriteria for a cardiac-imaging modality.

The panel considered which of 52 clin-ical scenarios were appropriate indicationsfor single-photon emission computed to-mography myocardial perfusion imaging(SPECT MPI), which were inappropriateindications for SPECT, and which were un-certain indications ( J. Am. Coll. Cardiol.2005;46:1587-605).

The criteria have been endorsed by theAmerican Heart Association.

The panel judged SPECT to be a gener-ally acceptable and reasonable approach in27 of the clinical scenarios. These includedevaluation of asymptomatic patients withhigh Framingham risk of coronary heartdisease (CHD), asymptomatic patients withcoronary calcium scores of 400 or greater,and patients with chest-pain syndrome anda high pretest probability of coronaryartery disease who are unable to exercise orwho have an unreadable ECG.

The panel found SPECT to be general-ly unacceptable and an unreasonable ap-proach in 13 of the scenarios. These in-cluded the evaluation of asymptomaticpatients with low Framingham risk ofCHD and asymptomatic patients with car-diac calcium scores less than 100; it wasalso unacceptable for preoperative risk as-sessment of noncardiac surgery patients.

The remaining 12 scenarios were thosethat may be generally acceptable and maybe a reasonable approach, but for which ad-ditional data are necessary. These includedevaluations of asymptomatic patients withmoderate Framingham risk of CHD,asymptomatic patients diagnosed withstenosis of unclear significance after CTangiography, and asymptomatic patientsfor the first 5 years post revascularization.

The authors of the criteria recom-mended that third-party payers should def-initely reimburse for the appropriate anduncertain indications, but that reimburse-ment for indications judged inappropriateshould require a documented exceptionfrom the physician ordering the study.

“These new technologies are terrific,”said Dr. Ralph G. Brindis, chair of theACCF appropriateness criteria workinggroup. “They offer new advances in diag-nosis and treatment. But we need to beable to use them in the appropriate set-tings, [with] the right patient at the righttime and for the right indication.”

Dr. Brindis, a cardiologist from Oakland(Calif.) Kaiser Medical Center, said that thecost of care was one of the main motiva-tions for considering appropriateness cri-

teria for SPECT. “I think we owe it to ourpatients and to the cardiovascular com-munity as a whole to better get our handson the burgeoning costs of cardiovascularcare,” he said in an interview with thisnewspaper.

Funded by almost $1 million fromACCF, future panels will consider otherimaging modalities, including CT, MRI,and echocardiography.

Dr. Brindis said that he cast a wide netwhen recruiting the 12 members of thetechnical panel. In addition to specialists innuclear cardiology, the panel included gen-eral cardiologists, experts in echocardiog-raphy, an outcomes researcher, and thechief medical officer of a health insuranceprovider.

Although the American College of Ra-diology (ACR) was invited to send a pan-elist, they declined, Dr. Brindis said.

“The ACR made a vigorous effort toidentify a member of the college to rep-resent us in this effort,” said ACR presi-dent, Dr. Milton J. Guiberteau, in an in-terview. “But we were unable to do so ina time frame to fit the already-begunprocess. It certainly wasn’t a snub of theprocess, because we applaud these effortseven though we have some differences inthe way we approach them. I think over-all it was a well-constructed document.”

The ACR has developed appropriatenesscriteria for 170 clinical indications sincetheir first in 1993. Their approach is to takea clinical indication, such as chest pain, andrank the available tests in terms of whatwould be the most appropriate. “Whenyou just do it from a modality approach,it doesn’t tell you whether SPECT my-ocardial perfusion imaging is preferable toechocardiography or to a simple stresstest, which is a lot cheaper,” Dr. Guib-erteau said.

The ACC has already provided such aranking in its clinical practice guidelines,countered Dr. George A. Beller, the RuthC. Heede Professor of Cardiology andprofessor of internal medicine at the Uni-versity of Virginia, Charlottesville, whowas not involved in developing the ap-propriateness criteria.

Dr. Beller said he found few surprises inhis reading of the SPECT appropriatenesscriteria. “Where I think it might be usefulis for reinforcing the clinical practice guide-lines for primary care physicians so theywould have a better feeling for who theymight refer for testing,” he said.

Dr. Brindis said the appropriateness cri-teria may eventually affect pay-for-perfor-mance criteria, which are now based ex-clusively on quality.

“I expect over time that pay-for-per-formance criteria will extend outside ofthe quality arena and will include areassuch as cost-effectiveness and efficiency,”he said.

And he’s pleased with the reception thenew appropriateness criteria have received.“I’ve had nuclear cardiologists tell us thisis too restrictive, and I’ve had some acad-emic nonnuclear cardiologists saying wedidn’t go far enough,” he said. “If we [failedto make] both sides happy, that means wemust be pretty close to the truth.” ■

Appropriateness criteria may eventually go beyond

quality to include cost-effectiveness and efficiency.

Panel Releases Criteria for SPECT

WE NEED TO BE ABLE TO USECARDIAC IMAGING WITH ‘THERIGHT PATIENT AT THE RIGHT

TIME AND FOR THE RIGHTINDICATION.’

B Y E L I Z A B E T H M E C H C AT I E

Else vier Global Medical Ne ws

The potential for interactions withcyclosporine was one of the mainsafety concerns expressed by a

federal advisory panel supporting ap-proval of nonprescription availability ofthe weight loss drug orlistat.

At a joint meeting of the Food andDrug Administration’s nonprescriptiondrugs advisory committee and the en-docrinologic and metabolic drugs advi-sory committee in January, panel mem-bers voted 11-3 in favor of making60-mg capsules of orlistat available overthe counter for weight loss. Since 1999,120-mg orlistat has been available by pre-scription as Xenical in the United States.The label of the prescription drug in-cludes a warning about not co-adminis-tering orlistat with cyclosporine, al-though cyclosporine use is not listed asa contraindication in the current label.

Orlistat works locally in the GI tractto prevent absorption of up to 30% ofdietary fat. However, cyclosporine ab-sorption is decreased when taken withorlistat, and the FDA has postmarket-ing reports of subtherapeutic concen-trations in transplant recipients, in-cluding two reports of organ rejection,one mild case and another moderate.

The proposed label and package fornonprescription orlistat warns not touse orlistat if taking cyclosporine, or “adrug given after organ transplant.”

GlaxoSmithKline officials referred to44 reports of people on cyclosporinewho took orlistat, which included 38cases with low cyclosporine serum lev-els. Of these cases, 2 patients had issueswith their grafts, but were treated suc-cessfully.

In several cases reviewed by the FDA,serum cyclosporine levels droppedrapidly when orlistat therapy was start-ed and fell to subtherapeutic levels. ■

CyclosporineInteracts

With WeightLoss Drug

6 NEWS T H O R AC I C S U R G E R Y N E W S • MARCH/APRIL 2006

by weaknesses in cardiothoracic surgerytraining programs and parallel declines inapplications to those programs, said Dr.Wheatley in an address at an Internation-al Symposium on Endovascular Treat-ment of Thoracic Aorta Disease.

“If you look at the training programs inthe United States, you see that there is awhole bunch of lung, esophagus, con-genital heart disease, adult cardiac andeven pacemakers, and bronchoscopy andesophagoscopy; but the number of en-dovascular procedures currently requiredby the American Board of ThoracicSurgery is zero, and I think that needs tochange, both for our specialty and our abil-ity to offer our best to patients,” he said.

Between 1993 and 2006, applications tothoracic surgery resident programsdropped from more than 180 to about 120.In addition, 2005 was the first year that thenumber of applicants was lower than thenumber of available slots, which Dr.

Wheatley calls a “virtual crisis situation.”Dr. Salerno, who is chief of the division

of cardiothoracic surgery at the Universi-ty of Miami’s Jackson Memorial MedicalCenter, said cardiothoracic surgeons atthe University of Miami “no longer openthe chest for thoracic aortic diseases, andwe use stents for most diseases of the aor-ta. We as a specialty need to look at en-dovascular skills as a means for our futuredevelopment.” He warned that failure todevelop stenting expertise will hasten thetransfer of thoracic aneurysm treatmentfrom cardiothoracic surgeons to cardiac in-terventionalists, a situation that already isevident in coronary artery stenting.

“One of the important aspects of this in-ternational symposium ... is discussingthe new role that cardiothoracic surgeonsare playing in the treatment of aortic dis-eases utilizing the percutaneous approach.Rather than delegating this procedure tointerventional cardiologists, cardiac sur-

geons are recognizing that the time hascome to lay their hands on catheters andto make them part of their armamentar-ium,” said Dr. Salerno, who is also a pro-fessor of surgery at the university.

Collaborative training is critical to thefuture of cardiovascular surgery, he added.“At our center, fellows have been fortunateto have an opportunity to work with bothcardiologists and surgeons in the en-dovascular treatment of thoracic diseases.”

The number of formal endovascularfellowships must be expanded and publi-cized, added Dr. Wheatley. “And as a spe-cialty, we need to get more involved in en-dovascular-oriented symposia andresearch and we need to have more hands-on catheter and guidewire courses. If youhave the catheter and guidewire skills todo thoracic endografting, then you will bea prime candidate for getting involved inpercutaneous valve technology.”

Because most patients with thoracicaortic disease will have peripheral vascu-lar disease, “we need to be able to do stent-ing or balloon angioplasty to becomecomplete cardiovascular specialists,” he

said, explaining that carotid stenting alsois an opportunity for thoracic surgeons al-ready working on the aortic arch.

“A lot of our patients have combinedcarotid/CABG procedures, so why not bethe ones doing the carotid stenting? Whyyield that to our colleagues?” said Dr.Wheatley.

“[Almost all] current cardiovascularpathology will be treated by endovascularprocedures in the future. But it’s not go-ing to be by the classic cardiac surgeon ...it’s going to be vascular specialists or thecardiovascular specialists who have inte-grated catheter and wire skills into theirpractices,” said Dr. Wheatley.

The current direction of medical tech-nology was foreseen by Dr. Charles Dotter,who was considered the father of en-dovascular interventions. Even before heperformed his first endovascular procedurein 1964, Dr. Dotter made what Dr. Wheat-ley considers a prescient remark: “The an-giographic catheter can be more than a toolfor passive means for diagnostic observa-tion; used with imagination, it can becomean important surgical instrument.” ■

Endovascular Training NeededEssential Skills • from page 1

B Y B E T S Y B AT E S

Else vier Global Medical Ne ws

S A N F R A N C I S C O — Surgeonsview collaboration, communica-tion, and teamwork in their oper-ating rooms through rose-coloredglasses, in sharp contrast to theperspective of nurses and techni-cians working alongside them, ac-cording to survey results present-ed by Dr. Martin Makary at theannual clinical congress of theAmerican College of Surgeons.

“We think we’re doing a greatjob.” But the nurses, anesthesiol-ogists, and technicians “see someproblems that we don’t see,” saidDr. Makary, who serves on thefaculty of the departments ofsurgery and public health at JohnsHopkins University in Baltimore.

Dr. Makary surveyed 2,135 sur-gical team members, includingsurgeons, anesthesiologists, certi-fied registered nurse-anesthetists,scrub nurses, and technicians,about social dynamics in the op-erating room that have beenproven to affect surgical out-comes. Surgical team memberswho were surveyed worked in 60hospitals across 16 states, said Dr.Makary, who also represents thesurgery department in the uni-versity’s center for innovation inquality patient care.

He found that surgeons ratedthe quality of their colleagues’collaboration and communica-tion skills in the operating room(OR) much higher than their col-leagues rated them. On a 100-point scale, surgeons rated fellowsurgeons at 85, anesthesiologistsat 84, and nurses at 87.

Nurses rated surgeons at 48,and anesthesiologists rated sur-geons at 70.

Furthermore, Dr. Makaryfound significant discrepanciesamong surgeons, anesthesiolo-gists, and others in the OR in howthey responded to statementssuch as “I have the support I needfrom other personnel in caringfor patients,” “It is easy to askquestions,” and “We work well to-gether as a coordinated team.”

Surgeons generally thought allwas well, whereas other teammembers disagreed.

“This is a topic that speaks to theissue of a nurse in the OR know-ing that a sponge is retained in theabdomen but not saying anythingbecause of the hierarchy that wehave espoused” throughout thehistory of our profession, Dr.Makary said. “It speaks to thenurse in the OR realizing that a pa-tient is receiving an organ with thewrong blood type but not sayinganything because the last time shedid she was criticized.” The stakesare high, he emphasized.

A study by the Joint Commis-sion on Accreditation of Health-care Organizations found thatcommunication was the rootcause of more than 60% of “sen-

tinel events” in hospitals, Dr.Makary said. For example, com-munication failures can be tracedto almost 80% of wrong-site surg-eries, he noted.

The formal discussant for Dr.Makary’s paper, Dr. Edward J.Dunn, said the commission’s studycontained a “pretty serious mes-sage . . . about the communicationdisconnect in operating rooms.”

A cardiothoracic surgeon whonow works with the Veterans Af-fairs national center for publicsafety, Dr. Dunn said a first step inmaking improvements is for sur-geons to realize how others feel.

If nurses don’t feel respected,don’t believe they have the pow-er to speak up, and don’t feel theirinput has value, then they alsodon’t believe they’re members ofa team and won’t participate assuch, he said.

After a study of 7,000 adverseincidents in the VA revealed that78% were due to failed commu-nication, the VA decided to takecommunication seriously.

The VA has been closing ORsfor 1 day to conduct a peer-to-peerteam training program in whichcolleagues interactively discussnine filmed clinical vignettes thatdepict various barriers to collabo-ration and communication. Thetraining is being administered inoperating rooms throughoutmuch of the VA system.

Studies of the effectiveness ofthe training program are ongo-ing, but they seem to indicatethat establishing rules of conductand talking as a team are centralelements for improved commu-nication, Dr. Dunn said. ■

Perceptions of Teamwork in theOperating Room Differ Sharply

Heart Patient Gets $5 Million in Fraud Case

B Y J OY C E F R I E D E N

Else vier Global Medical Ne ws

AMaryland jury has awarded$5 million to a heart

surgery patient who claimedthat a cardiology group misledhim into believing that hisheart surgeon—who was not amember of the group—wasunavailable to perform bypasssurgery. As a result, the patientwas operated on by a differentsurgeon and experienced com-plications that required him toundergo additional procedures.

The Baltimore County juryfound that two physicians withMidatlantic Cardiovascular As-sociates—cardiac surgeon Dr.Jeffrey E. Sell and Dr. MarkMidei, cardiologist and directorof the cardiac catheterizationlaboratory at St. Joseph Med-ical Center, Towson, Md.—committed fraud by steeringthe patient, Harry Bargar, toDr. Sell, who was employedby the practice, rather than toDr. Peter Horneffer, who hadpreviously operated on Mr.Bargar.

The jury also found Dr. Sellguilty of battery for operatingon Mr. Bargar without havingvalid consent to do so.

The jury awarded Mr. Bargarand his wife $2.25 million incompensatory damages, to bepaid by the two doctors andMidatlantic. It also awarded thecouple another $2.75 million inpunitive damages, to be paidby Midatlantic.

Dr. Horneffer is a memberof Cardiac Surgery Associates(CSA), Towson, a rival cardiac

surgery practice. When Midat-lantic was adding cardiac sur-geons to its roster as part of itstransformation into a multi-specialty cardiology group,CSA was invited to merge withMidatlantic. CSA declined, andits referrals from Midatlanticdropped precipitously onceMidatlantic recruited other car-diac surgeons.

William F. Gately, attorneyfor the Bargars, said the verdictwas “thoroughly and entirelyappropriate. For any physiciansto do to a patient what this juryfound that these two physi-cians did to Harry Bargar is ob-scene,” he said.

Mr. Gately is also the attor-ney in a lawsuit that CSA hasfiled against Midatlantic, charg-ing it with “unfair bargainingpower over health careproviders” and accusing it ofviolating federal antikickbacklaws in connection with de-mands it made of CSA duringmerger negotiations. That suitis still pending.

Linda Harder, spokeswomanfor Midatlantic, said the com-pany plans to appeal the ver-dict in the Bargar case.

“Our physicians would nev-er, ever mislead a patient, andthey didn’t in this case,” shesaid. “Midatlantic has referredabout 10,000 patients for car-diac surgery in the last 5 years.Only about 75% were referredto Midatlantic surgeons, andthe other 25% were referred toother surgeons. They wouldalways strive to honor a pa-tient’s wishes in terms of heartsurgery.” ■

ESTABLISHING RULES OFCONDUCT AND TALKING AS

A TEAM ARE CENTRALELEMENTS FOR IMPROVED

COMMUNICATION.

MARCH/APRIL 2006 • T H O R AC I C S U R G E R Y N E W S GENERAL THORACIC 7

ercise capacity had no difference in sur-vival between the LVRS and medicalgroups, but those in the surgical groupwere more likely to function better thanwere those who received medical treat-ment.� Patients with mostly non–upper-lobeemphysema and low exercise capacity hadsimilar survival and exercise ability after

LVRS as after medical treatment, but hadless shortness of breath.� Participants with mostly non–upper-lobe emphysema and high exercise capac-ity had poorer survival after LVRS than af-ter medical treatment, and LVRS andmedical participants had similar lowchance of functioning better (N. Engl. J.Med. 2003;348:2059-73).

The following year, Spanish researcherspublished a study suggesting that theBODE index predicts survival, with pa-tients in the first quartile (BODE index 0-2) having a 20% 4-year mortality and

those in the fourth quartile (BODE 7-10)having an 80% mortality at 4 years (N.Engl. J. Med. 2004;350:1005-12).

Based upon these studies, Dr. Ledererand his colleagues launched their study,asking, “Since LVRS may improve sur-vival and BODE may predict survival,does LVRS improve the BODE index?”Of all patients evaluated for LVRS over15 months, only 23, or 20%, were ap-proved.

Their average age was 63 years and 65%were women. All had upper-lobe pre-dominant emphysema and met NETT in-clusion criteria. Seven had upper-lobe em-physema with low exercise capacity, while16 had upper-lobe emphysema and highexercise capacity, as defined by NETT.The group underwent LVRS after com-pleting pulmonary rehabilitation.

“The vast majority were using inhaledcorticosteroids and long-acting bron-chodilators. About half were usingtiotropium and the rest were using ipra-tropium. Oxygen was used by 57% and themedian modified Medical Research Coun-cil dyspnea score was 3,” said Dr. Leder-er. He added that 14 patients underwentbilateral thoracoscopic LVRS, while 9 un-derwent median sternotomy.

“Our median length of stay was 8 daysin the hospital and 2 days in the ICU.There were no deaths perioperatively or atfollow-up. Prolonged air leak, which was

not unexpected, occurred in 39% of pa-tients. There was one episode each ofpneumonia, infected pleural space, ar-rhythmia, and excessive transfusion,” Dr.Lederer said.

Among the 12 patients forwhich 6-month data are avail-able, forced vital capacity in-creased from 54% to 71% pre-dicted; forced expiratoryvolume in 1 second (FEV1) in-creased from 26% to 35% pre-dicted; and total lung capacityimproved from 121% to 106%,”Dr. Lederer said.

“The total lung capacity ra-tio, which recently was shownto be a prognostic indicator inpatients with COPD, improvedfrom 22% to 33%. And it’s im-portant to note that diffusioncapacity of carbon monoxide,though it did not increase sig-nificantly, did not go down either. Maxi-mum exercise capacity increased from 36to 48 watts.

There was a clinically meaningful in-crease in 6-minute walk of around 50 me-ters, but it didn’t reach statistical signifi-cance. And the [Medical Research Council]dyspnea score improved from a median of3 to a median of 1,” he said, adding thatthese findings are consistent with those ofNETT.

“LVRS works in the real world, not justin a randomized trial, and it sets the stagefor our finding that LVRS improved theBODE index. The median BODE index

prior to surgery was 5, placing the patientsin the third quartile with a predicted 4-yearmortality of 40%. Six months aftersurgery, the BODE index decreased to amedian of 2.5, which placed them some-

where between the first andsecond quartiles” (20%-30%predicted 4-year mortality),Dr. Lederer said.

“If we break the BODE in-dex into its four components,it’s clear ... that the improve-ments were due to improve-ments in FEV1 from a medianof 3 to a median of 2, and im-provements in dyspnea from amedian of 2 to 0.”

Allowing for the study’s lim-itations, including its “smallsample size and only 6-monthfollow-up,” Dr. Lederer con-cluded that it did show thatLVRS improves BODE index,

“and from the NETT study we know thatLVRS improves survival, but what weneed to determine with more research iswhether changes in the BODE index arepredictive of the magnitude of benefitdown the road.”

If that proves to be the case, Dr. Leder-er sees enormous potential for the index,predicting that, in addition to helpingphysicians select COPD patients forsurgery, it will facilitate research into newinterventions for COPD. By trackingchanges in BODE scores, investigatorswould be able to predict outcomes with-out enrolling thousands of patients. ■

BODE Index ImprovementLVRS • from page 1

We need todetermine if

changes in BODEpredict the

amount of benefitdown the road.

DR. LEDERER

B Y B R U C E K . D I X O N

Else vier Global Medical Ne ws

M O N T R E A L — Physiciansshould not exclude a diagnosis ofpulmonary embolism based onarterial blood gas analysis, ac-cording to a study presented atthe annual meeting of the Amer-ican College of ChestPhysicians.

“Instead, theyshould continue torely on D-dimer andclinical predictionmodels, such as theWells criteria, or goon to diagnosticimaging,” said Dr.Tara Keays of theUniversity of OttawaHospital.

Researchers havetried to come upwith bedside investi-gation tools to ruleout this commonand lethal disease without theneed for more invasive and ex-pensive diagnostic imaging priorto the initiation of anticoagula-tion therapy.

The most successful results in-volve blood testing for D-dimer, afibrin degradation product that isproduced only after a clot hasformed and is in the process ofbeing broken down, in combina-

tion with a clinical algorithm.(See box.)

Recently, initial studies com-bining D-dimer with arterialblood gas (ABG) values as a di-agnostic method showed im-pressive negative predictive val-ues, but efforts to validate thoseresults have been unsuccessful.

In the retrospectivestudy presented byDr. Keays, her teaminvestigated the roleof ABG and D-dimervalues using datafrom a double-blind,randomized con-trolled trial compar-ing bedside diagnos-tic tests withventilation/perfusion(V/Q) scanning in theexclusion of suspect-ed pulmonary em-bolism (PE).

“In the derivationstudy, PE was exclud-

ed if two of the three bedsidestudies were negative; the V/Qscan was normal or near normal;or the patient was not started onanticoagulation at the end of theinvestigation.

PE was confirmed by a high-probability V/Q; by low or in-termediate probability V/Qalong with another diagnosticmodality being positive; on au-

topsy; or if anticoagulation wasstarted by the end of the investi-gation,” Dr. Keays said.

Patients were excluded fromthe study if they were agedyounger than 18 years, had a sus-pected survival of less than 3months, were ventilated, hadknown chronic PE, were on an-ticoagulation, or had vena cavalinterruption.

Of the 824 patients screened,458 were eligible and 399 con-sented, and 278 had ABG drawninitially. Of the total cohort of399 patients, 14% were diag-nosed with PE.

“Looking at the continuousABG values, there was no signif-icant difference in the meanPaCO2, PaO2 or Aa gradient be-tween the two groups. However,when we looked at the propor-tion of abnormal ABGs and D-dimer values, there was a signif-icant difference,” Dr. Keaysexplained.

“Our clinical prediction rulesimply states that PE is possible ifD-dimer is positive or if the D-dimer is negative and there’s anabnormal PaCO2 and an abnor-mal Aa gradient,” she said.

The negative predictive valueand sensitivity of the rule were100%, she noted, with a true neg-ative proportion of 38%, mean-ing that, in this population, “38%

of patients could be correctly ex-cluded as not having PE.”

However, a subsequent at-tempt to validate these findingsin a retrospective secondaryanalysis of 246 patients was notas clear-cut. This study produceda negative predictive value of91%, a sensitivity of 89%, and atrue negative proportion of30%.

“In the derivation study, it didappear that normal PaCO2 and

normal Aa gradient, combinedwith a negative D-dimer, couldexclude PE without the need fordiagnostic imaging. However, inthe validation group this clinicalprediction rule did not appear tovalidate.

“Therefore, normal ABG datain combination with negative D-dimer does not allow safe exclu-sion of PE without going on todiagnostic imaging,” Dr. Keaysconcluded. ■

Arterial Blood Gas Values Cannot Rule Out PE

Astudy of D-dimer in com-bination with a clinical al-

gorithm revealed a negativepredictive value of 99.5% inpatients designated as havinga low probability of embolism(Ann. Intern. Med. 2001;135:98-107).

What has become known asthe Wells clinical model as-signs probability points to thefollowing seven clinical signsand symptoms:1. Evidence of deep vein

thrombosis (3.0).2. Heart rate higher than 100

beats per minute (1.5).3. Previous objectively diag-

nosed deep vein thrombo-sis or pulmonary embolism(1.5).

4. Immobilization for three ormore consecutive days orsurgery in the previous fourweeks (1.5).

5. Hemoptysis (1.0).6. Malignancy (1.0).7. Pulmonary embolism as a

highly likely diagnosis (3.0).“Managing patients for sus-

pected pulmonary embolismon the basis of pretest proba-bility and D-dimer result issafe and decreases the needfor diagnostic imaging,” theinvestigators concluded.

Wells Criteria for PulmonaryEmbolism Diagnosis

‘Normal ABG datain combinationwith negative

D-dimer does notallow safe

exclusion of PE.’DR. KEAYS

‘LVRS WORKS IN THE REAL WORLD,NOT JUST IN A RANDOMIZED

TRIAL, AND IT SETS THE STAGEFOR OUR FINDING THAT LVRSIMPROVED THE BODE INDEX.’

8 GENERAL THORACIC T H O R AC I C S U R G E R Y N E W S • MARCH/APRIL 2006

B Y S H A R O N W O R C E S T E R

Else vier Global Medical Ne ws

The addition of the antioxidant acetyl-cysteine to the standard treatmentfor idiopathic pulmonary fibrosis sig-

nificantly slowed disease progression in pa-tients in a randomized, controlled study.

A total of 182 patients with usual in-terstitial pneumonia were randomizedto receive standard treatment with pred-nisone and azathioprine plus placebo orthe standard treatment plus 600 mgacetylcysteine given three times daily.The absolute difference in the changefrom baseline among the 71 patients inthe acetylcysteine group and the 68 in theplacebo group for whom data were ana-lyzed was 0.18 liters (relative difference of

9%) for vital capacity, and 0.75mmol/min per kilopascal (relative differ-ence of 24%) for single-breath carbonmonoxide diffusing capacity (N. Engl. J.Med. 2005;353:2229-41).

The number and type of adverse eventswere similar in the two groups, exceptthose in the acetylcysteine group had a sig-nificantly lower rate of bone marrow tox-icity. Mortality at up to 1 month aftertreatment completion was also similar at9% for the acetylcysteine group and 11%for the placebo group, Dr. MauritsDemedts of Katholieke Universiteit Leu-ven (Belgium) and colleagues reported.

Although the beneficial effects ofacetylcysteine did not translate into asignificant survival benefit, the results ofthis multinational, double-blind study

have clinical relevance, according to theinvestigators.

The addition of acetylcysteine—whichwas previously shown to restore depletedpulmonary glutathione levels and improvelung function in patients with fibrosing

alveoli when given at the same high doseused in the present study—is rational inthose with idiopathic pulmonary fibrosis(IPF). Larger studies are needed to deter-mine the effects of acetylcysteine on sur-vival, they said.

Dr. Demedts and his colleagues alsonoted that the present study “does notpermit firm conclusions regarding theeffects and side effects of treatment withprednisone plus azathioprine given thatthere was no placebo group for thesedrugs.”

In an accompanying editorial, Dr. GaryW. Hunninghake, director of the pul-monary, critical care, and occupationalmedicine division at the University ofIowa, Iowa City, elaborated on this point.

He stated that it is plausible that acetyl-cysteine is directly beneficial as a therapyfor IPF, but it is also possible that theprednisone and azathioprine combinationis toxic to IPF patients, and that acetyl-cysteine prevents the toxicity (N. Engl. J.Med. 2005;353:2285-7).

“A prospective study comparing pred-nisone and azathioprine with placebo isneeded to address this issue,” Dr. Hun-ninghake wrote. ■

Although there was no significant survival benefit

for IPF, the findings are deemed clinically relevant.

Adding Acetylcysteine May Slow Fibrosis Progression

THE NUMBER AND TYPE OFADVERSE EVENTS WERE SIMILARIN THE TWO GROUPS, BUT BONEMARROW TOXICITY WAS LOWERIN THE ACETYLCYSTEINE GROUP.

B Y B R U C E K . D I X O N

Else vier Global Meidcal Ne ws

M O N T R E A L — Endoscopic ul-trasound-guided fine-needle as-piration appears to be more ac-curate than PET withradiolabeled 2-fluoro-deoxy-D-glucose for staging mediastinallymph nodes in non–small celllung cancer, according to re-search presented at the annualmeeting of the American Collegeof Chest Physicians.

Mediastinal lymph node stag-ing determines surgical re-sectability in patients withnon–small cell lung cancer(NSCLC), said Dr. Rosemary F.Kelly of the Veterans AffairsMedical Center in Minneapolis.“Ideally, a surgical candidate hasa disease process that is limitedto the lung or parenchymallymph nodes only. Parenchymalnodes are considered N1 nodes,and in N0 or N1 disease the roleof surgery is clear. N2 disease in-volves metastasis to the ipsilat-eral mediastinal lymph nodes.”Resection here is potentially cur-ative, she noted, especially whenthere is a positive response toneoadjuvant therapy.

Dr. Kelly stressed that “this isthe patient population that iscritical to accurately identify pre-operatively.”

The Minneapolis team con-ducted a prospective, nonran-domized study during May2003–May 2005 of 65 patientssuspected or proven to haveNSCLC who were operative can-didates and were not suspected ofhaving metastatic disease. Con-ventional clinical staging wasdone preoperatively with CT. Inaddition, FDG-PET scan and en-doscopic ultrasound (EUS) were

done on every patient preopera-tively, explained Dr. Kelly.

Pathologic staging was donefor all patients by medi-astinoscopy and/or nodal dissec-tion at the time of thoracotomyin any patient not already diag-nosed by EUS with malignancyor definitive benign diagnosis.“Patients with a definitive benigndiagnosis were still followed for 1year to confirm the accuracy ofthe diagnosis,” she said.

A PET scan was consideredpositive when the me-diastinal uptake wasdistinctly separatefrom the primarymass. Positive PETusually is defined ashaving a standard up-take value greaterthan 2.5. “Any inter-mediate or indeter-minate uptake in themediastinum wasconsidered negativefor this study, Dr. Kel-ly said. To optimizethis study, “the nu-clear medicine physi-cian was not blindedto the CT scan results.”

In all nodal stations except sta-tion 7, “all identified nodes werebiopsied. In the subcarinal area,only nodes [larger than 5 mm],with distinct margins, round oroval, or with a hypoechoic echo-texture were biopsied. [Fine-nee-dle aspiration] passes were doneuntil a diagnosis of malignancywas made, or until the cy-topathologist was convinced ofthe accuracy of the sample. Forbenign disease, at least four pass-es were made for each node iden-tified. A staff cytopathologist waspresent for each procedure andconfirmed the diagnosis or ade-

quacy of the sample,” she said.Within the cohort, 41 patients

were known to have NSCLC,whereas 24 did not have a diag-nosis prior to EUS. These pa-tients were divided into two sub-groups: those with normallymph nodes on CT scan (31 pa-tients with clinical stage I dis-ease) and those with enlargednodes (3 patients with clinicalstage IIIA disease).

In the stage I group, three offour positive PET scans were

shown by EUS to betrue malignancy. Ofthe 27 negative PETscans, 6 turned up pos-itive on EUS. These sixpatients with unex-pected malignancywere restaged to IIIA.EUS determined thefourth tumor to be be-nign, and there was noevidence of malignan-cy in the mediastinumin 21 patients. The al-gorithm “demonstrat-ed that while EUS was100% accurate in stageI NSCLC, PET imag-

ing had false-positive and [false-]negative results,” said Dr. Kelly.

“The most concerning wouldbe the false negatives, where theoptimal treatment with neoadju-vant therapy would not be of-fered unless routine medi-astinoscopy was being done.Hopefully, the false-positive PETwould have been identified accu-rately by mediastinoscopy if EUSwas not available.”

In the clinical stage IIIA group,PET identified 16 patients as be-ing negative and 18 patients ashaving potential disease.EUS–fine-needle aspiration con-firmed 14 of those 18 positives.

Of the remaining four, “two hadmalignancy, but these were inpatients [in whom] station 4Rnodes were known to be en-larged and positive on PET butinaccessible by EUS. These pa-tients . . . were accurately diag-nosed” with mediastinoscopy,Dr. Kelly said.

Among those deemed nega-tive on PET scan, four were ini-tially reversed by EUS, but EUSmissed two that were actuallymalignant. “These two patientshad malignancy diagnosed bymediastinoscopy [in which] itwas evident that the node wasnot entirely involved by cancerand was a sampling error ofEUS,” Dr. Kelly explained, con-cluding that PET had ratherhigh false negative and false pos-itive rates.

In the overall analysis, PET hada sensitivity of 61%, a specificityof 91%, and an accuracy of 77%,compared with 87%, 100%, and94%, respectively, for EUS. Innormal-sized lymph nodes, EUSscored 100% across the board,including positive and negativepredictive values.

“PET is an interesting modali-ty in that it clearly picks up un-suspected areas of malignancyand can improve the specificity ofthe CT scan, especially in themediastinum. However, it thenstill requires tissue confirmationin PET-positive and PET-nega-tive scans. So you are still stuckusing EUS or mediastinoscopy.

“The role of PET in directingEUS may be helpful, but we didnot blind the endoscopist to thePET and CT results, so we arenot able to comment on the roleof PET in this situation. Also,PET may be helpful in identify-ing unsuspected extrathoracic

metastatic sites, but I have notstudied this question,” Dr. Kellysaid in an interview.

Advantages of EUS includethe ability to diagnose tissue aswell as the procedure’s low com-plication rate compared withvideo-assisted thoracic surgery,mediastinoscopy, transthoracicbiopsy, and transbronchial biop-sy, Dr. Kelly said.

“It is also able to reach nodalareas not within reach of a me-diastinoscope. Finally, EUS isable to biopsy the adrenal glandsand the liver when there arequestions of metastasis. Overall,EUS is an excellent second stepin staging after CT scan becauseit is able to pursue abnormalitiesnoted on CT and give tissue con-firmation, and it is able to detectmetastasis in normal-sizedlymph nodes,” she said.

The downsides of the proce-dure, she added, are that it re-quires an experienced endo-scopist and an experiencedcytopathologist to be present atthe time of the procedure toconfirm adequate sampling, andit is unable to reach the anteriorparatracheal nodes, particularlyon the right at the tracheo-bronchial angle.

“For this reason, medi-astinoscopy following EUS—where a tissue diagnosis was notpossible—may be more thor-ough and complementary to theareas accessible by EUS,” shesaid.

With these limitations in mind,Dr. Kelly strongly recommendsEUS over PET, noting that endo-scopists and cytologists often areavailable at major institutions be-cause the same techniques are be-ing applied to esophageal, gastric,and pancreatic cancers. ■

Endoscopic Ultrasound Trumps PET in Staging Lymph Nodes

‘While EUS was100% accurate instage I NSCLC, PETimaging had false-positive and [false-]negative results.’

DR. KELLY

Focused righton cardiac surgery.

Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. All rights reserved. ©2005 ATS Medical, Inc. 2527-000

A company that knows what it means to be passionateabout cardiac surgery. ATS Medical. www.atsmedical.com.

clined after lung volume reduction surgery(LVRS). Preoperatively, 92% of patients re-quired supplemental oxygen with maxi-mum exertion. At 6 months, 1 year, and 5years after surgery, the percentages were50%, 56%, and 80%, respectively.

“There was a significant improvementin physical ability during the preoperativerehabilitation period. There was a furtherincrease in performance after the opera-tion,” he said. “This improvement wasmaintained for 3 years, followed by a grad-ual decline. Exercise tolerance after 5 yearswas not worse than preoperative scores.”

In the 250 patients at Barnes-JewishHospital, the mean follow-up was 5 yearswith a minimum time interval of 18months. Follow-up was complete for allpatients but one. Patients judged suitablefor surgery were enrolled in a 3-monthpreoperative pulmonary rehabilitationprogram, said Dr. Cooper, chief of the di-vision of thoracic surgery at the Universi-ty of Pennsylvania, Philadelphia.

The postrehabilitation, preoperativedata were used as the baseline for com-parisons with postoperative data.

After surgery, health-related quality oflife, according to the Short Form 36 Phys-ical Functioning Scale scores, showedmarked improvement over that reportedby the same patients following rehabili-tation but prior to surgery. Of the pa-tients, 96% felt better at 6 months aftersurgery, and almost 88% felt better at 1year, he reported.

“Thus, experience with LVRS in well-se-lected patients has confirmed that reduc-tion of hyperinflation in patients withend-stage emphysema can provide verysignificant benefit to the patient. Basedupon this principle, several endoscopicapproaches to reduce hyperinflation inpatients with severe emphysema are beinginvestigated,” Dr. Cooper said.

Emphysema affects about 3 million in-dividuals in the United States and, to-gether with other forms of chronic ob-structive pulmonary disease, is the fourthleading cause of death. As emphysema-tous destruction of the lung progresses,gas exchange is progressively impaired bythe loss of alveolar surface area, whichleads to progressive limitation of exercisetolerance and the need for supplementaloxygen administration, said Dr. Cooper.

A second consequence of the parenchy-mal destruction is the loss of lung elasticrecoil, which leads to progressive hyper-inflation, he said.

The crippling effects of emphysema arerelated in large measure to the adverse ef-fects of hyperinflation on respiratory me-chanics, which is associated with an in-crease in the work of breathing.

The medical management of end-stageemphysema includes bronchodilators, an-tibiotics, and inhaled or systemic steroids—all directed at improving expiratory airflowto reduce hyperinflation, improve respira-tory mechanics, increase exercise toler-ance, and reduce dyspnea, Dr. Coopersaid. “Once medical therapy, including ex-ercise rehabilitation, has been maximized,therapeutic strategies are limited, and in-clude lung transplantation and LVRS.”

Lung volume reduction surgery is de-

Respiratory Mechanics Improved Emphysema • from page 1

signed to reduce hyperinflation and im-prove respiratory mechanics in patientswith end-stage emphysema, but the pro-cedure is appropriate only when the pat-tern of destruction is heterogeneous, al-lowing essentially nonfunctional, grosslyoverinflated portions of the lung to be re-moved, said Dr. Cooper.

“The benefits of LVRS have been wellestablished and include objective im-provements in FEV1 and forced vital ca-pacity, and reduction in total lung capaci-

ty and residual volume,” Dr. Cooper said.“Clinically, this is associated with a less-ened sense of dyspnea and improved ex-ercise tolerance, as well as a significant im-provement in quality of life.”

Many patients with end-stage emphyse-ma are not suitable candidates for LVRS be-cause of a homogeneous pattern of de-struction. In these patients, there are no“target areas” that could be excised forLVRS or that can undergo volume reduc-tion by means of endobronchial valves.Nonetheless, these patients are subject tothe same crippling effects of hyperinflationas are other end-stage emphysema patients.

“To reduce hyperinflation in these pa-

tients, we are developing a procedure, re-ferred to as airway bypass, by which directcommunication is provided between seg-mental bronchi and adjacent lungparenchyma by means of stents placedthrough the bronchial wall with one endin the airway and the other in the lungparenchyma,” Dr. Cooper said. Because ofthe extensive collateral ventilation in suchpatients, several airway bypass stents candeflate an entire lung. The feasibility of ap-plying this procedure to emphysema pa-tients has been demonstrated. “Phase Iclinical trials have confirmed the safety andefficacy of this approach in a small seriesof patients,” he said. ■

MARCH/APRIL 2006 • T H O R AC I C S U R G E R Y N E W S GENERAL THORACIC 9

10 CARDIOPULMONARY TRANSPLANT T H O R AC I C S U R G E R Y N E W S • MARCH/APRIL 2006

Operative mortality and intubation rate were

similar in the repair and nonrepair groups.

Cardiac Repair Doesn’tRaise Transplant Risks

B Y D I A N A M A H O N E Y

Else vier Global Medical Ne ws

O R L A N D O — Cardiac interven-tions performed as a prerequisite toor concurrent with lung transplan-tation do not increase operativemorbidity or mortality, comparedwith lung transplantation in pa-tients who do not need cardiac in-tervention, a retrospective studyhas shown.

The findings suggest that thepresence of cardiac disease, if itcan be addressed, should not pre-clude lung transplantation, said Dr.Scott B. Johnson at the annualmeeting of the Southern ThoracicSurgical Association.

“Given the relative scarcity ofdonor organs, especially for lungs,recipient selection criteria must becontinuously reevaluated so that or-gan allocation remains appropriate,”said Dr. Johnson.

Toward this end, he and col-leagues at the University of TexasHealth Science Center in San An-tonio “began to ask ourselveswhether we were doing the rightthing by performing lung trans-plantation in patients who alsoneeded cardiac interventions.”

The thoracic surgeons reviewedthe charts of all the patients whounderwent lung transplantation attheir institution between the years1994 and 2004.

During the 10-year period, 132lung transplantations were per-formed in 130 patients. Of the fullcohort, 13 of the patients had asso-ciated cardiac procedures. In 6 ofthe 13 patients, the cardiac inter-ventions were performed in antici-pation of the transplant and in-cluded three angioplasty/stentplacements, two coronary arterybypass surgeries, and one mitralvalve replacement. The remainingseven patients had concomitant car-diac procedures, including fivepatent foramen ovale (PFO) clo-sures, one coronary artery bypasssurgery, and one ventricular septaldefect closure.

The primary indication for lungtransplantation for the cardiac in-tervention group was fibrotic re-strictive lung disease. For the non-

cardiac group, chronic obstructivelung disease was the most commonindication for the surgery, said Dr.Johnson.

Mean age, gender, and number ofpostoperative days on the ventilatorwere similar for both groups. “Ofnote is the fact that 47% of the non-cardiac group and 46% of the car-diac group were intubated for lessthan 24 hours,” said Dr. Johnson.And although the median length ofhospital stay tended to be longer inthe cardiac group, the differenceswere not statistically significant, headded.

There was a statistically signifi-cant increase in the number of bi-lateral transplants performed in thecardiac group, but this differencedid not have an impact on outcome,according to Dr. Johnson.

“The operative mortality in bothgroups was similar, with a rate of7.7% [one death] in the cardiacgroup and 7.5% [nine deaths] in thenoncardiac group,” he said. The pre-dominant cause of death in all pa-tients was primary graft failure andsepsis. The one death in the cardiacgroup occurred in a patient whohad a bilateral transplant with con-current PFO closure.

With respect to morbidity, 51 ofthe 111 survivors in the noncardiacgroup developed a total of 101 com-plications, for an overall morbidityrate of 46%.

By comparison, 7 of the 12 sur-vivors in the cardiac group devel-oped a total of 12 complications, foran overall morbidity rate of 58%—representing a non–statistically sig-nificant increase, according to Dr.Johnson. The most common com-plications in both groups werereperfusion injuries after take-backsto the operating room for any rea-sons, he said.

The Kaplan-Meier survival curvesfor both groups showed no statisti-cally significant differences. Howev-er, “most of our survivors from thecardiac group are not yet out past 3years from surgery, while some fromthe cardiac group are much fartherout,” noted Dr. Johnson.

Nonetheless, he said, “our con-clusion from this investigation isthat patients who are otherwisedeemed good candidates for lungtransplantation but who are foundto have associated cardiac abnor-malities should still be consideredfor transplantation if the cardiaccondition can be addressed success-fully before the transplant, or con-comitant with the transplant. Doingso does not appear to increase op-erative mortality or adversely affectlong-term survival.” ■

THE PRESENCE OF CARDIACDISEASE, IF IT CAN BE

ADDRESSED, SHOULD NOTPRECLUDE LUNG

TRANSPLANTATION.

B Y M A RY E L L E N

S C H N E I D E R

Else vier Global Medical Ne ws

N E W Y O R K — Surgeons atColumbia University in NewYork are performing laparo-scopic Nissen fundoplicationin many lung transplant re-cipients who show evidenceof significant gastroe-sophageal reflux and chronicrejection, Dr. Joshua R.Sonett said at a conference onpulmonary and critical caremedicine sponsored by Co-lumbia University.

The theory behind thesurgery is that gastroe-sophageal reflux disease(GERD) contributes to lunginjury and the developmentof bronchiolitis obliterans syn-drome (BOS), an Achilles heelfor long-term survival of lungtransplant patients. Hence,preventing GERD will im-prove lung function and pre-vent chronic rejection aftertransplant, said Dr. Sonett,surgical director of the Co-lumbia University lung trans-plant program.

In a study published in 2003,researchers from Duke Uni-versity, Durham, N.C., foundthat performing fundoplica-

tion in lung transplant recipi-ents with GERD improvedlung function ( J. Thorac. Car-diovasc. Surg. 2003;125:533-42). The researchers used anesophageal pH probe to assessreflux, and found abnormal pHvalues in 93 of 128 patients(73%) who had undergone alung transplant. Patients whounderwent fundoplication had

improved bronchiolitis obliter-ans syndrome scores, andsome no longer met the crite-ria for BOS.

Researchers at the Universi-ty of Toronto obtained similarresults, said Dr. Sonett.

The improvement in scoresexhibited by those who re-ceived fundoplication is key,because for most lung trans-plant recipients who begin tohave bronchiolitis obliterans

syndrome, there is no turningback, Dr. Sonett said.

In addition to contributingto BOS, reflux disease causesbronchospasm and aspiration,and exacerbates asthma, headded.

Thus far, there have beenvirtually no effective thera-pies to stop chronic rejection,he said.

“We now know that chron-ic reflux can lead to chronicrejection in the lung,” Dr.Sonett said. “It’s not thewhole story, but there’s cer-tainly a population of patientspost transplant who have re-flux that go on to chronic re-jection, and if you stop thatreflux, they will stop havingchronic rejection.”

Researchers also have be-gun to consider the role thatreflux disease plays in patientswith interstitial lung diseaseand other lung diseases pre-operatively.

Clearly, physicians shouldnot perform reflux proceduresin patients just because theyhave GERD and interstitiallung disease, he said, but re-searchers need to continue tolook at what subset of patientscould benefit from antirefluxprocedures. ■

GERD Surgery Can BenefitLung Transplant Patients

Clinical Need, Likely Survival WillDictate Lung Allocation

B Y M A RY E L L E N

S C H N E I D E R

Else vier Global Medical Ne ws

N E W Y O R K — The newneed-based lung allocationsystem that went into effectlast May has the potential toreduce the number of deathsof patients on the waiting listfor a transplant, Dr. Joshua R.Sonett said at a conference onpulmonary and critical caremedicine sponsored by Co-lumbia University.

The new system allocateslungs on the basis of clinicalneed and likely survival aftertransplant rather than on thesole basis of time spent on thewaiting list. The United Net-work for Organ Sharing giveseach patient a score from 0 to100 based on an algorithm thatincludes the patient’s diagnosisand other factors that affectsurvival both on the waitinglist and post transplant.

The new design could helppatients in later stages of dis-ease who, under the old sys-

tem, might not have survivedthe 1-3 years on the waitinglist, said Dr. Sonett, surgicaldirector of the ColumbiaUniversity lung transplanta-tion program.

The old system also wastedtime when a lung becameavailable because physicianshad to sort through hundredsof patients who were high onthe waiting list but weren’tready for a transplant. Underthe new system, patientsmove up or down the list onthe basis of clinical changes,so they should be given a highscore only when they areready for a transplant, he said.

But the system has potentialdrawbacks, Dr. Sonett said.For starters, the new design iscomplex and has not beenprospectively evaluated. In ad-dition, because patients nolonger spend years accruingtime on the waiting list, theymay be less physically and psy-chologically prepared for theirtransplant.

A lung transplant is com-

plex, and patients’ conditioningis critical to their 5- and 10-yearsurvival, Dr. Sonett said. It’skey for physicians to make ear-ly referrals to a transplant teamso patients can begin to pre-pare for a transplant, he said.

Officials at the Departmentof Health and Human Ser-vices published a final rule in1999 that required the UnitedNetwork for Organ Sharingto amend organ distributionalgorithms to direct organs tothose most in need—thosemost at risk of death withouta transplant. This was to bebalanced with utility to avoidfutile transplants.

The problem under the oldsystem was that too many pa-tients on the list were dying asthey waited for a transplant.But the challenge in revisingthe system to reflect a need-based approach is that pul-monary diseases are so differ-ent from most other diseasesthat it’s difficult to figure outwhich patients are sicker, Dr.Sonett said. ■

‘CHRONIC REFLUX CANLEAD TO CHRONIC

REJECTION.’ IF THATREFLUX CAN BE

STOPPED, REJECTIONCOULD BE STOPPED.

MARCH/APRIL 2006 • T H O R AC I C S U R G E R Y N E W S CONGENITAL HEART 11

B Y B R U C E J A N C I N

Else vier Global Medical Ne ws

S T O C K H O L M — Pregnancy inwomen with isolated congenitalpulmonary valve stenosis is associ-ated with an extremely high rate ofobstetric and fetal complications,Dr. Willem Drenthen reported atthe annual congress of the Euro-pean Society of Cardiology.

The specific nature ofthese complications variesdepending on whether thecongenital heart defectwas surgically correctedbefore pregnancy, said Dr.Drenthen of UniversityMedical Center, Gronin-gen, the Netherlands.

Researchers assumedthat pregnancy in womenwith isolated congenitalpulmonary valve stenosisis well tolerated, but datafrom a Dutch national reg-istry indicate otherwise.The registry has thus fardocumented 81 complet-ed pregnancies in womenwith this congenital heart

defect. Of those, 44 cases involvedwomen whose valvular anomalywas surgically corrected beforepregnancy. Women who had notundergone surgery had only a mildpulmonary valve gradient.

About 60% of the pregnancies in-volved at least one obstetric and/orneonatal complication. There was ahigh incidence of pregnancy-in-duced hypertension in women with

uncorrected congenital pulmonaryvalve stenosis, as well as markedlyelevated rates of preterm labor anddelivery and postpartum hemor-rhage in patients with a correctedheart defect (see chart). Of the new-borns, 4% had congenital heart dis-ease. Neonatal mortality was 5%,with deaths due to immaturity,meningitis, and hydrocephalus com-bined with prematurity. ■

Pulmonary Stenosis Ups Obstetric Risks

Corrected (n = 44) Uncorrected (n = 37)Mean birth weight 2,883 g 3,346 gPregnancy duration 38 weeks 40 weeksComplications

Pregnancy-induced hypertension 5 (11%) 11 (30%)Infection requiring antibiotics 8 (18%) 6 (16%)Premature rupture of membranes 5 (11%) 0Preterm labor 9 (21%) 2 (5%)Preterm delivery 11 (25%) 2 (5%)Postpartum hemorrhage 9 (21%) 4 (11%)Thromboembolic complications 3 (7%) 0

Note: Patients may have multiple complications.Source: Dr. Drenthen

Pregnancy Complications With Congenital Pulmonary Valve Stenosis

Data Awaited on PFOClosure for Migraines

B Y D A M I A N

M C N A M A R A

Else vier Global Medical Ne ws

S C O T T S D A L E , A R I Z . —A subset of migraine pa-tients may benefit from clo-sure of their patent foramenovale, Dr. David W. Dodicksaid at a symposium spon-sored by the AmericanHeadache Society.

“We have a responsibility toknow the data and give pa-tients proper and appropriateadvice,” said Dr. Dodick, pro-fessor of neurology at MayoClinic Arizona.

Some research indicatesan association between aPFO and migraines withaura, particularly in patientswith a large left-to-rightshunt. In one study, patientswith migraine with aurawere three times more like-ly to have a PFO than thosewho experienced migraineswithout aura.

A left-to-right shunt is alsomore common among mi-graine-with-aura patients.

In the Migraine Interven-tion with STARFlex Tech-nology (MIST) study, patientswith migraine with aura areassessed by a cardiologistthen randomized to closureor no closure. In preliminaryresults, enrollment data show60% of 370 participants hav-ing a right-to-left shunt (ver-sus 27% of the general pop-ulation) and 38% having alarge PFO (versus 7% of thegeneral population).

Studies suggest that clo-sure eliminates migraines inabout one-third of mi-graineurs, reduces frequen-cy in another third, anddoes not alter attacks in an-other third of patients.Many headache specialistsstill take a conservativestance. There is a reportedperiinterventional adverse-event rate of about 6%. ■

N E W S F R O M T H E A S S O C I A T I O N

12 T H O R AC I C S U R G E R Y N E W S • MARCH/APRIL 2006

Registration and Housing is now openand can be accessed online atwww.aats.org until March 24, 2006.

The Preliminary Program for the 86thAnnual Meeting of the American Asso-ciation for Thoracic Surgery is nowavailable online at www.aats.org. Log on to view the Program.

The Developing the Academic Sur-geon Symposium, chaired by Drs.

Mark J. Krasna and John G. Byrne,will kick off the AATS annual meetingon Saturday afternoon and features dis-cussions on the future of academicpractice and training programs anddealing with conflicts of interest.

Sunday will feature three concurrentPostgraduate Course Symposia pre-sented by Dr. Stephen J. Mentzer asChairman of General Thoracic SurgerySymposium, Dr. Gus. J. Vlahakes asChairman of Adult Cardiac SurgerySymposium, and Dr. Erle. H. Austin

III as Chairman of Congenital HeartDisease Symposium.

On Wednesday, Dr. Philip Corcoran,chief of cardiothoracic surgery at Wal-

ter Reed Army Medical Center, will or-ganize the Global Thoracic SurgerySession entitled International Disaster

Relief and Bioterrorism Crisis Response.Dr Corcoran has put together a sessionthat will feature information regardinghow we as physicians might be calledupon to respond to a bioterrorismthreat. In addition, several speakerswill talk about the emergency medicalresponses that were organized for trainbombings in London and Madrid aswell as the U.S. Gulf Coast hurricane.

Concluding this year’s annual meetingare the popular Wednesday morningControversies in CardiothoracicSurgery, including a debate onwhether the decline in cardiothoracicsurgery applications is good for thespecialty. Other discussions include:

• Thoracic Aortic Stent GraftsShould Only Be Performed by CTSurgeons.

• Robotics Are the Future of Cardiac.• Esophagectomies Should Only Be

Performed in High-Volume Centers.• VATS Lobectomy Is the Best Oper-

ation for Clinical Stage 1 NSCLC.• Congenital Cardiac Surgeons.

Should Be Trained in an Accredited

Two-Year Fellowship.• Biological vs. Mechanical Valve Re-

placement of the Pulmonary ValveAfter Multiple Reconstructions ofthe RVOT Tract.

Invited SpeakersPresident, Dr. Richard A. Jonas, hasannounced his invited speakers for the2006 annual meeting. This year’s basicscience lecturer will be Dr. Robert

Horvitz of MIT. Dr. Horvitz is a 2002Nobel Laureate in physiology/medi-cine, which was awarded for his role indiscovering and characterizing thegenes involved in apoptosis and pro-grammed cell death. Apoptotic celldeath is of great importance in bothmyocardial and cerebral ischemic in-jury and is of great relevance to all car-diothoracic surgeons.The honoredguest lecturer will be Dr. John Howe,who is the President of Project Hope,a major philanthropic organizationcommitted to medical education ef-forts throughout the world. ProjectHope helped form the backbone ofU.S. medical relief efforts for severalnatural disasters including the Indone-sian tsunami as well as Hurricane Kat-rina in New Orleans.

This year’s Attendee Reception onTuesday evening will be held at theFranklin Institute. Come and experi-ence hands-on exhibits and explore science in disciplines ranging fromsports to space, including the SportsChallenge, which uses virtual realitytechnology to illustrate the physics ofsports; the Train Factory’s climb-aboard steam engine; the Space Com-mand’s simulated earth-orbit researchstation; a fully equipped weather sta-tion; and exhibits on electricity.

Additionally, spouses and guests mayparticipate in a selection of tours, in-cluding the Historic Philadelphia Walk-ing Tour; the Longwood GardensTour; and a Day in the Country: EastBank/West Bank. New this year will bea Financial Planning Seminar and Fit-ness Forum. ■

You must register for these activities.

Please visit our website at www.aats.org.

Annual Meeting News and EventsApril 29–May 3, 2006 • Pennsylvania Convention Center, Philadelphia, PA

The Thoracic Surgery Resi-dents Association (TSRA)

has recognized the need for resi-dents to be exposed to and totrain in new technologies andminimally invasive techniques.The TSRA, together with theThoracic Surgery Directors As-sociation (TSDA), and in collab-oration with the CTSnet.orgResidents Section, has developedthe Cardiothoracic Technology

Symposium. The Cardiotho-racic Technology Symposiumwill expose residents to newtechnologies and techniques incardiothoracic surgery, will dis-cuss the status and changes inthoracic surgery training, andwill enable residents to pursuefurther training in areas of inter-est. The strong alliance betweenthoracic surgery residents, pro-gram directors, and the CTS-net.org Residents Section willcreate an educationally sound,diverse curriculum highlightingnovel therapies, minimally inva-sive techniques, and new tech-nology in cardiothoracic surgery.The Cardiothoracic Technolo-

gy Symposium is designed ex-

clusively for thoracic surgery

residents in accredited pro-

grams and will be held May 19-

21, 2006 at the University of

Cincinnati Center for Surgical

Innovation and Marriott

Kingsgate Conference Center.

The Cardiothoracic Technolo-gy Symposium will consist of di-dactic sessions, a unique hands-on cadaver and animallaboratory experience, and aneducational session with leadersin thoracic surgery education.Didactic components will fea-ture speakers who are acknowl-edged experts in their fields.Unique to the Symposium willbe an opportunity to performnew surgical techniques and usenew technologies and productsin a cadaver/animal lab setting.The opportunity to perform dif-ferent techniques, exposures,and use new technologies underthe tutelage of faculty expertsseparates the CardiothoracicTechnology Symposium fromother resident courses. In addi-tion, there will be an educationalsession designed to promote dis-cussion between thoracic resi-

dents and leaders in thoracicsurgery education about evolv-ing changes and the future ofthoracic surgery education. Thissession is designed to provide di-rect information from the lead-ership of the major thoracicsurgery educational organiza-tions (American Board of Tho-racic Surgery/Thoracic SurgeryDirectors Association) to resi-dents regarding proposed andongoing changes in training pro-grams and manpower issues.The emerging need for surgicaldiversification and how to trainin emerging fields will also beaddressed.

The Cardiothoracic Technolo-gy Symposium is offered free toall thoracic surgery residents.Residents are encouraged to reg-ister at www.CTSymposium.org,as registration is limited to thefirst 80 residents on a first-comefirst-serve basis. All residentsmust be supported by a letterfrom their program director.Registration, lodging, and travelcosts will be paid by theTSRA/TSDA through the sup-port of industry sponsors. ■

Cardiothoracic Technology

Symposium for Residents

CME Activities Now

Available Using JTCVS

Future AATS Meeting

Dates and LocationsApril 29–May 3, 2006PennsylvaniaConvention CenterPhiladelphia, PA

May 5-9, 2007Washington DCConvention CenterWashington, DC

May 10-14, 2008San Diego ConventionCenterSan Diego, CA

May 9-13, 2009Hynes ConventionCenterBoston, MA

May 1-5, 2010Metro TorontoConvention CentreToronto, Ontario

More information canbe accessed at

www.aats.org

Keep up with thenewest developments

in cardiothoracic surgery.Earn journal-based contin-uing medical education(CME) credits from read-ing The Journal of Thoracic

and Cardiovascular

Surgery! Choose a CMEactivity in your area of in-terest at a time that is con-venient for you:• Surgery for Acquired

Cardiovascular Disease. • General Thoracic

Surgery. • Surgery for Congenital

Heart Disease.Go to http://cme.ctsnetjournals.org to ac-cess CME activities. Read a CME-designatedarticle; take the CME ac-tivity test and evaluationquiz; print your own cer-tificate. ■

Archived issues of the ThoracicSurgery News are available onlineat www.aats.org.

October 20 - 22, 2006 InterContinental Hotel and MBNA Conference Center

Cleveland, Ohio

The Cleveland Clinic Kaufman Center for Heart Failure

andThe American Association for Thoracic Surgery

present

www.clevelandclinicmeded.com/heartfailure06or www.aats.org

Synchronizing SURGICALand MEDICAL Therapies

for Better Outcomes

21st CENTURYTREATMENT of

HEARTFAILURE:

14 T H O R AC I C S U R G E R Y N E W S • MARCH/APRIL 2006

N E W S F R O M T H E

A S S O C I A T I O N

2005-2006

Officers and

CouncilorsPresident

Richard A Jonas, M.D.

Washington, DCPresident-Elect

Bruce W Lytle, M.D.

Cleveland, OhioVice President

D. Craig Miller, M.D.

Stanford, CaliforniaSecretary

Irving L Kron, M.D.

Charlottesville, VirginiaTreasurer

Alec Patterson, M.D.

St. Louis, MissouriEditor

Andrew S Wechsler, M.D.

Philadelphia, PennsylvaniaCouncilors

Tirone E David, M.D.

Toronto, OntarioCharles D Fraser, Jr, M.D.

Houston, TexasHartzell V Schaff, M.D.

Rochester, Minnesota Craig R Smith, M.D.

New York, New YorkDavid J Sugarbaker, M.D.

Boston, MassachusettsMarko I Turina, M.D.

Zurich, Switzerland

New NIH Policy

On Multiple PI

Grant Submissions

All Federal research agencies arepreparing to implement poli-

cies and procedures to formally al-low more than one Principal Inves-tigator (PI) on individual researchawards. This presents a new andimportant opportunity for investi-gators seeking support for projectsor activities that clearly require“team science.” The multiple-PIoption is targeted specifically toprojects that do not fit the single-PI model, and thus is intended tosupplement, not replace, the tradi-tional single PI model. The goal isto maximize the potential of teamscience efforts, responsive to thechallenges and opportunities ofthe 21st century. To view the back-ground information and featuresof the multiple-PI policy as well asthe major issues to be consideredin its implementation, go tohttp://grants2.nih.gov/grants/multi_pi.

B Y B R U C E J A N C I N

Else vier Global Medical Ne ws

D A L L A S — The use of NSAIDs—whether cyclooxygenase-2–selective ornot—in patients who’ve had an acute MIincreases their risk of mortality, especial-ly in higher doses, according to data fromthe Danish National Patient Registry.

To patients with ischemic heart disease,

“I would say that you should try to avoidthese drugs, but if you need to take them,use lower doses,” Dr. Gunnar H. Gislasonsaid at the annual scientific sessions of theAmerican Heart Association.

The widely publicized prior studies thatrevealed the increased risks of MI anddeath associated with NSAID use—andthat resulted in some COX-2-selectiveagents being taken off the market as well

as an across-the-board black box la-bel warning for allN S A I D s — w e r ebased largely on pa-tient populationswith an averagebackground cardio-vascular risk. Dr.Gislason and hisc o i nve s t i g a t o r ssought to learnwhether the in-creased cardiovas-cular risk associatedwith NSAID usealso applied to pa-tients at very highcardiovascular risk:

namely, those who’ve already had an MI.Funding for their study was provided bythe Danish Heart Foundation.

Dr. Gislason reported on all 58,432 pa-tients discharged from Danish hospitalsfollowing a first acute MI during 1995-2002. A centralized national prescriptiondatabase revealed that more than 40% ofthese first-MI survivors subsequently filledat least one prescription for an NSAID.Nearly 10% of all patients used a COX-2inhibitor after having their MI.

The two most widely used, older, non-selective NSAIDs in Denmark are ibupro-fen (used by 17.5% of the post-MI pa-tients), and diclofenac (used by 10.6%).Rofecoxib was taken by 5.2% of the pa-tients, whereas celecoxib was used by 4.3%.

The use of a COX-2 inhibitor in high dos-es—that is, more than 25 mg/day for rofe-coxib or 200 mg of celecoxib—was associat-ed with a four- to fivefold increased mortalityrisk during the time a patient was on the drug,compared with NSAID nonusers. Lower-dose therapy with a COX-2 inhibitor was as-sociated with a lesser—albeit significantly in-creased—mortality risk. (See box.) The riskcalculations were adjusted for comorbid ill-nesses, age, gender, and socioeconomic sta-

tus, according to Dr. Gislason of BispebjergUniversity Hospital, Copenhagen. High-dosetherapy with nonselective NSAIDs was alsoassociated with increased mortality risk.

The rate of out-of-hospital deaths wasunusually high in the NSAID users, and thecauses are being examined using deathcertificate data. One possibility is thatNSAID users had an excess of arrhythmicdeaths outside the hospital. In addition,hospitalization for heart failure after an MIwas more common among users of COX-2 inhibitors. ■

MARCH/APRIL 2006 • T H O R AC I C S U R G E R Y N E W S ADULT CARDIAC 15

INDEX OF ADVERTISERS

ATS MedicalCorporate 9

Bayer Pharmaceuticals CorporationCorporate 20

Cook IncorporatedAAA Endovascular Graft 2

ETHICON ENDO-SURGERY, Inc.Echelon 60 5

Vitalcor, Inc.Applied Fiberoptics 11

NSAID Use After Acute MI Increases Mortality Risk

Low dosageHigh dosage

IbuprofenDiclofenacCelecoxibRofecoxib

Adjusted Risk of Mortality of Post-MI Users of NSAIDs, Compared With Nonusers

Note: Based on all 58,432 patients discharged from Danish hospitals after their first acute MI during 1995-2002.Source: Dr. Gislason

5.0

2.2

4.2

1.7

3.8

0.7

2.0

0.7

B Y M I T C H E L L . Z O L E R

Else vier Global Medical Ne ws

D A L L A S — Infusion of bone-mar-row progenitor cells into a coronaryartery after a myocardial infarctionled to significantly improved left ven-tricular function in a controlledstudy with almost 200 patients.

“This is the first large, proof-of-concept trial to clearly show thebenefit of progenitor cells inpost–myocardial infarction pa-tients,” Dr. Volker Schächinger saidat the annual scientific sessions ofthe American Heart Association.

“Large-scale clinical–end point tri-als are now needed to assess the ef-fect of intracoronary infusion ofbone-marrow cells on morbidity andmortality in patients,” said Dr.Schächinger, professor of medicine atJ.W. Goethe University in Frankfurt.

“The data give compelling evi-dence of the treatment’s benefit,”but the new findings conflict with aprior report from Belgian researchersthat failed to show increased ven-tricular function following similartreatment, commented Dr. PhilippeMenasche, a cardiovascular surgeonat the Georges Pompidou EuropeanHospital in Paris. Because of theseconflicting findings, “additional,large-scale trials are warranted toclarify the efficacy issue,” he said.

The study enrolled 204 patientswho had an ST-segment elevationMI and who were successfully reper-fused with either a percutaneouscoronary intervention or a throm-

bolytic drug. The study was done at16 medical centers in Germany and1 in Switzerland. At 3-6 days fol-lowing the MI, 50 mL of bone mar-row was aspirated from each pa-tient and filtered through a ficollgradient to enrich for progenitorcells, which takes about 90 minutes.

Patients then received an infusioninto their infarct-related artery of ei-ther the progenitor cells in growthmedium, or the medium with nocells, as a control. An average of 236million cells were infused into eachpatient who received bone-marrowcells. They were introduced with astop-flow catheter that briefly haltedblood flow within the treated artery.Left ventricular ejection fraction(LVEF) was measured at the time oftreatment and 4 months later, usingleft-ventricular angiography.

During follow-up, LVEF increasedby an average of 3.0% over baselinein 92 evaluable control patients andby an average of 5.5% in 95 evalu-able patients who received bonemarrow cells, a statistically signifi-cant effect for the study’s primaryend point, Dr. Schächinger said.

Two additional analyses weredone to identify conditions thatwere linked to the best outcomes.One divided the patients into the 93evaluable patients who had an LVEFof less than 49% at baseline and the94 evaluable patients with LVEF of49% or greater at baseline.

In the patients with LVEF of lessthan 49%, treatment with bone-mar-row cells led to an average 7.5%

boost in LVEF, compared with an av-erage 2.5% improvement in controlpatients, a statistically significant dif-ference. In patients who had LVEF of49% or greater at baseline, cell treat-ment led to no significant improve-ment, compared with the controls.

The other exploratory analysis di-vided patients based on when theywere treated after their MI. Patientswho received cell treatment 5 ormore days after their infarction hadan average 7.0% increase in LVEF,compared with an average 1.9% in-crease among control patients, a sig-nificant difference. Patients treatedless than 5 days after their infarctiondid not have a significant improve-ment, compared with the controls.

The researchers aren’t sure whypatients responded better if treat-ment was delayed a few days. “Ear-ly after a myocardial infarction, themyocardium is a hostile environ-ment, with inflammation and ox-idative stress. That may be why it’sbetter to delay treatment,” Dr.Schächinger said. “We can’t drawconclusions regarding the mecha-nism ... [but] we clearly showed abenefit that’s better than placebo.”

The Frankfurt researchers plan todo a study with about 1,200 patientsthat will focus on treating patientswith an LVEF of less than 50%, andwith marrow-cell treatment delayeduntil at least 6 days after an MI, Dr.Andreas M. Zeiher, professor andchief of cardiology at Goethe Uni-versity and senior investigator forthe study, said in an interview. ■

Bone-Marrow Cells Boost LeftVentricular Function After MI

CVD, ErectileDysfunction Link

B Y R O B I N S E AT O N

J E F F E R S O N

Else vier Global Medical Ne ws

Erectile dysfunctionshould be considered a

red flag that a man is at in-creased risk for cardiovas-cular events and deservesevaluation, according to Dr.Ian M. Thompson of theUniversity of Texas, San An-tonio, and his associates.

They prospectively as-sessed a cohort of 9,457men for both of these dis-eases over the course of 7years ( JAMA 2005;294:2996-3002). The men in thisstudy were the subset ofparticipants enrolled in theProstate Cancer PreventionTrial who were randomizedto placebo. As part of thatstudy, they were evaluatedevery 3 months for cardio-vascular disease and erectiledysfunction.

Of the 9,457 men ran-domized to placebo, 8,063(85%) had no cardiovascu-lar disease (CVD) at base-line; of these, 3,816 (47%)had erectile dysfunction atstudy entry. Of the 4,247men without erectile dys-function at study entry,2,420 (57%) reported inci-dent erectile dysfunctionafter 5 years.

Risk factors of CVD and

erectile dysfunction aresimilar, judging from find-ings from proportionalhazards regression models.

Incident erectile dys-function signaled an in-creased risk for subsequentcardiovascular events (haz-ard ratio of 1.25). For menwith either incident orprevalent erectile dysfunc-tion, the risk was greater(hazard ratio 1.45). For sub-sequent cardiovascularevents, the unadjusted riskof an incident cardiovascu-lar event was 0.015 per per-son-year in men withouterectile dysfunction atstudy entry and was 0.024per person-year for menwith erectile dysfunctionat study entry. This associ-ation was in the range ofrisk associated with currentsmoking or a family histo-ry of myocardial infarction,the authors reported.

An increasing number ofmen aged 40-69 years havebeen seeking care for erec-tile dysfunction since theadvent of effective drugtherapy. That office visitgives physicians an oppor-tunity to screen such menfor standard cardiovascularrisk factors, “and, as ap-propriate, initiate cardio-protective interventions,”Dr. Thompson wrote. ■

16 ADULT CARDIAC T H O R AC I C S U R G E R Y N E W S • MARCH/APRIL 2006

B Y B R U C E J A N C I N

Else vier Global Medical Ne ws

D A L L A S — Most patients whopresent with type A acute aorticdissection have an aortic diame-ter below the threshold at whichpreventive aneurysm surgery isrecommended in current surgi-cal guidelines, Dr. Linda A. Papesaid at the annual scientific ses-sions of the American Heart As-sociation.“We have the problem of diam-eter not appearing to be a verygood predictor of dissectionrisk,” observed Dr. Pape of theUniversity of Massachusetts,Worcester.

She reported on 591 patientswith type A acute aortic dissec-tion enrolled in the Internation-al Registry of Acute Aortic Dis-section. The registry, founded inthe mid-1990s, includes 21 cen-ters in 11 countries that havepooled resources to learn moreabout this disorder. All patientshad measurements of their aor-tic diameter at dissection viaMRI, transesophageal echo, CT,and/or angiography.

Current guidelines recom-mend preventive surgery whenthe maximum ascending aorticdiameter reaches 5.5 cm in pa-tients without Marfan syndromeand 5 cm in those with Marfan.

That’s the threshold at which therisk of dissection or rupture be-comes sufficient to outweigh themorbidity of major surgery.

But in the first-ever study of itskind to examine the issue in alarge unselected patient popula-tion, Dr. Pape found fully 59% ofpatients had a maximum ascend-ing aortic diameter less than the5.5-cm cutoff.

“A surprisingly high 40% of pa-tients dissected at diameters lessthan 5 cm,” the cardiologistadded.

Patients who dissected at lessthan 5.5 cm had higher rates ofreported back pain, radiatingpain, abrupt onset of pain, and

more neurologic deficits than didpatients with an aortic diameterof 5.5 cm or greater at dissection,but rates of such complaints

were high in both groups. Inter-estingly, the 5% of patients withMarfan syndrome were more

likely to present with a diametergreater than 5.5 cm.

Overall, mortality in the studywas 27%.

“Aortic size is not a sufficientmarker of risk for dissection. Inorder to prevent aortic dissectionand its potentially catastrophicoutcome, we need better meth-ods—genetic, biomarkers, or aor-tic functional studies—to identi-fy patients at risk,” Dr. Pape said.

These findings boost the rapid-ly evolving field of endovascularaneurysm repair. Percutaneousprocedures entail much less mor-bidity than does open surgery,making it reasonable to repairsmaller aneurysms. ■

Guidelines Fail to Prevent Most Type A Aortic Dissections

B Y B R U C E J A N C I N

Else vier Global Medical Ne ws

D A L L A S — Newly updated joint na-tional percutaneous coronary interven-tion guidelines have some cardiologistsseeing red.

The major point of contention regard-ing the first update of the guidelines since2001 concerns the use of PCI in centerswithout on-site surgical backup.

“Of all the areas we covered in theguidelines, this is the area that’s going toraise the most controversyand interest,” Dr. William W.O’Neill predicted at a pressconference announcing re-lease of the guidelines duringthe annual scientific sessionsof the American Heart Asso-ciation.

As in the 2001 guidelines,the new version nixes electivePCI at centers without on-sitesurgical backup. Primary PCIfor patients with ST-segmentelevation MI, when done inexperienced centers lackingon-site surgical backup, gets aclass IIb recommendation—the weakest possible endorse-ment—meaning there is divergent expertopinion and “less well established” sup-porting evidence.

Dr. Sidney C. Smith Jr., who headed theguideline writing committee, said thegroup was persuaded to retain the rec-ommendation against elective PCI in theabsence of on-site surgical backup chieflyby a large study of the Medicare databasethat showed worse outcomes in such set-tings.

“That carried the weight,” according toDr. Smith, professor of medicine and di-rector of the Center for CardiovascularScience and Medicine at the University ofNorth Carolina, Chapel Hill.

“There is no access-to-care issue in theU.S. about angioplasty. We have minimalwaiting times,” added Dr. O’Neill, corpo-rate chairman of cardiology for theWilliam Beaumont Hospital System, Roy-al Oak, Mich. “There really is no proofthat we could see right now that doing

these procedures [without on-site backup]enhances the value to the patient or makesit safer—if anything, it could make itworse.”

But Dr. Thomas P. Wharton Jr. said inan interview that since the 2001 guide-lines there have been 15 new studies ofPCI at hospitals without on-site backup;the committee failed to cite or apparent-ly consider 12 of them, all of which werepositive, a deficiency he termed “notfathomable.”

Collectively these studies, he said, boostprimary PCI with-out on-site backupinto a legitimateclass IIa procedureand make a strongcase for elective PCIas a class IIb recom-mendation.

Among thesestudies was one pre-sented at the sameAHA meeting thatinvolved more than660,000 consecutivePCIs included in theAmerican College ofCardiology’s rigor-ous prospective Na-

tional Cardiovascular Data Registry. In-hospital mortality in the 6,530 patientswho underwent primary or nonemergentPCI without on-site backup was compa-rable to that in patients who had PCI withon-site backup. The guidelines task forcewas provided with the results of this andthe other studies, said Dr. Wharton of Ex-eter (N.H.) Hospital.

PCI is underutilized both for acute MIand for high-risk acute coronary syn-dromes. Providing PCI without on-sitebackup will improve access and therebylower mortality rates. This far outweighsthe downside risk of 1-2 patients per1,000 experiencing a PCI complication re-quiring emergency bypass surgery with-in 2 hours, which with good transferplanning in place can be accomplishedoff-site, he added.

“Performance of PCI at qualified hos-pitals with off-site surgical backup is agrowing grassroots movement. It’s being

done in 36 states. More states are chang-ing their regulations to allow it. The ACCshould recognize it and set standards,”Dr. Wharton said.

Other key recommendations in the newguidelines are as follows:�� Volume requirements. As in 2001, the2005 guidelines recommend that electivePCI be performed by physicians who do atleast 75 PCI procedures per year, and incenters where more than 400 per year aredone.

But the institutional volume require-ment may be head-ed for the scrapheap. In another re-port from the ACCNational Cardiovas-cular Data Registrypresented at theAHA meeting, Dr.William S. Wein-traub and his coin-vestigators foundno evidence of a re-lationship betweeninstitutional PCIvolume and in-hos-pital mortality in aseries of nearly668,000 patients

who underwent PCI in the contemporaryera of improved stents and antiplatelet reg-imens.

“The task force is aware of our data,”Dr. Weintraub said in an interview. “Ithink before they change their recom-mendations, they’re going to want to seeour final results in print.

“The next version of the guidelineswill probably get away from the institu-tional volume requirement,” predictedDr. Weintraub, director of outcomes forthe Christiana Care Health System,Newark, Del.�� Left main coronary artery disease—

a new PCI target. Considered the exclu-sive domain of surgeons since the incep-tion of bypass surgery, left main disease isfor the first time deemed reasonably ad-dressed via PCI provided the patient is apoor surgical candidate.

The guidelines go on to state that com-pletion of ongoing clinical trials will be re-

quired before it’s known whether PCI isalso appropriate for left main disease ingood candidates for coronary artery by-pass graft, according to Dr. Ted Feldman,professor of medicine at NorthwesternUniversity, Chicago, and past president ofthe Society for Cardiovascular Angiogra-phy and Interventions, which developedthe new PCI guidelines together with theAHA and ACC.�� Distal embolic protection devices.

These devices have been declared essentialwhenever technically feasible in patients

undergoing PCI of saphenousvein grafts. However, the de-vices haven’t as yet beenshown to be beneficial in pa-tients undergoing primary PCIfor acute MI.�� An expanded role for in-

terventionalists in postpro-

cedural patient management.

Aggressive LDL-cholesterollowering to a target below 70mg/dL is recommended invery high risk patients. Theguidelines also emphasize therole of specific antiplatelet reg-imens involving aspirin plusclopidogrel, as well as the useof ACE inhibitor and β-block-

er therapy. And all diabetic patients needto have a hemoglobin A1c below 7%.

“Interventional cardiologists are alreadyawfully busy, and we don’t expect them totake on the management of diabetes. ButHb A1c is a pretty good indicator of dia-betic control, and it’s an easy test for theinterventional cardiologist to draw in thehospital,” Dr. Smith said.

“If better control is needed, they can re-fer the patient back to the primary carephysician. We really think it’s an oppor-tunity for the interventionalist to get thepatient off in the right direction,” headded.

The full 122-page guidelines with their109 recommendations are available on theWeb sites of the ACC (www.acc.org),AHA (www.my.americanheart.org), andSociety for Cardiovascular Angiographyand Interventions (www.scai.org).

The guidelines will be published in printform in January. ■

On-Site Surgical Backup Requirement for PCI Debated

There is no proofthat proceduresdone without on-

site backupenhance the value

to the patient.DR. O’NEILL

Trial results areneeded before

deciding if PCI isappropriate for left

main disease inbypass patients.

DR. FELDMAN

Interventionalcardiologists are

busy, and we don’texpect them to

take on diabetesmanagement.

DR. SMITH

‘WE HAVE THE PROBLEMOF DIAMETER NOT

APPEARING TO BE A VERYGOOD PREDICTOR OFDISSECTION RISK.’

Doctors of the World • 375 West Broadway, 4th Floor • New York, NY 10012, USA • info@dowusa.org

MAKING HEALTH A HUMAN RIGHT

We’re Doctors of the World-USA: an American nonprofit,humanitarian organization dedicated to providing essential medicalcare to those most in need. No matter who they are, or wherethey live. Our volunteers are American healthcare professionalswho believe that health is a human right for all people.

To make a donation or volunteer, call our toll-free number today.

1.888.817.HELPwww.doctorsoftheworld.org

WANTING TO HELP IS ONLY HUMAN DOING SOMETHING ABOUT IT IS ONLY RIGHT

WANTING TO HELP IS ONLY HUMAN DOING SOMETHING ABOUT IT IS ONLY RIGHT

B Y B R U C E J A N C I N

Else vier Global Medical Ne ws

S T O C K H O L M — Routine use of drug-eluting stents in a real-world patient set-ting is not good value for money, accord-ing to the findings of the first-everrandomized trial that compared drug-elut-ing stents with bare-metal stents in unse-lected patients in a study free of industrysponsorship.

The results of the Basel Stent Cost Ef-fectiveness Trial (BASKET) suggest thatthe use of drug-eluting stents (DESs)could reasonably be restricted to selectedhigh-risk patient subgroups, Dr. MatthiasPfisterer said at the annual congress of theEuropean Society of Cardiology.

“Based on these data, we can definesome subgroups where these stents aremore attractive. They are more cost effec-tive in patients older than 65 years withthree-vessel disease, more than one treat-ed segment, longer lesions, and small treat-ed vessels. This will hold true until the

price of drug-elut-ing stents falls sig-nificantly,” said Dr.Pfisterer of the Uni-versity of Basel(Switzerland). In atypical catheteriza-tion laboratory, per-haps two-thirds ofpatients fit that de-scription, he added.“Turning the dataaround,we can saythat younger pa-tients with single-or double-vessel dis-ease, short lesions,and large stent sizes

fare very well with bare-metal stents.”BASKET involved 826 consecutive pa-

tients treated at University Hospital ofBasel with angioplasty and stenting for1,281 de novo coronary lesions. They wererandomized to the sirolimus-coatedCypher stent, the paclitaxel-coated Taxusstent, or the cobalt-chromium–based Vi-sion third-generation bare-metal stent(BMS). The study was funded by the uni-versity in response to questions from car-diologists and hospital administratorsabout the impact of the growing use ofDESs on the hospital budget.

Unlike previous randomized stent trialsthat were funded by device manufacturersand featured highly selected patient pop-ulations, BASKET was designed to reflecteveryday clinical practice in the catheteri-zation laboratory. Three-fifths of the par-ticipants presented with acute MI or un-stable coronary syndromes. Sixty-ninepercent of enrollees had multivessel dis-ease, and one-half of those had involve-ment of the left anterior descending coro-nary artery. Patients received a mean of1.9 stents with a mean total stent lengthof 34 mm.

The 6-month combined efficacy endpoint of cardiac death, MI, or target ves-sel revascularization occurred in 12.1% ofthe BMS group and in 7.2% of the DESgroup. This difference was driven largelyby the 43% reduction in target-vesselrevascularization in DES-treated patients.

Routine Use of Drug-Eluting Stents Not Cost EffectiveThere was a consistent trend for fewer ma-jor adverse cardiac events with the Cypher,compared with the Taxus DES; however,the sample size was too small to deter-mine statistical significance. The cardiacevent rate in the BMS group was lowerthan might be anticipated in such a rela-tively high-risk population, most likely be-cause the Vision stent is more effectivethan the earlier-generation steel stents,the cardiologist observed.

The mean 6-month total costs were10,544 euros per patient with the DESs

and 9,639 euros per patient with the BMS.It cost a mean of 18,311 euros to avoid onemajor adverse cardiac event through theuse of drug-eluting, rather than bare-met-al, stents.

The estimated cost per quality-adjustedlife year gained through the use of drug-eluting in lieu of bare-metal stents was55,000-73,000 euros, depending on thequality of life measure that was used.Those estimates fall outside the range ofwhat most health economists define ascost-effective therapy.

Dr. Kim M. Fox, professor of clinical car-diology at Royal Brompton Hospital,London, said that although the BASKETtrial provides important information aboutthe limitations of the cost-effectiveness ofDESs, interventional cardiologists willpoint to the devices’ superior efficacy andfind ways to expand their use.

“Patients will ask for drug-eluting stentsmore and more,” agreed Dr. Pfisterer.“It’s a difficult task to tell a patient drug-eluting stents are better—as we haveshown—but you aren’t getting one.” ■

‘It’s a difficult taskto tell a patient

drug-eluting stentsare better ... butyou aren’t getting

one.’DR. PFISTERER

MARCH/APRIL 2006 • T H O R AC I C S U R G E R Y N E W S ADULT CARDIAC 17

18 DEVICES & TRIALS T H O R AC I C S U R G E R Y N E W S • MARCH/APRIL 2006

B Y J E F F E VA N S

Else vier Global Medical Ne ws

R O C K V I L L E , M D. — Investigators whodevelop pediatric circulatory support de-vices will encounter many challenges inthe regulatory process, which should beaddressed early on in the device and trialdesign stages and in discussions with theFood and Drug Administration, said Dr.Christopher Almond at a meeting spon-sored by the FDA.

Most of these investigators will seekagency approval for a humanitarian de-vice exemption (HDE) because of thehigh-risk, groundbreaking nature of theresearch and the small number of chil-dren who would benefit from the devices,said Dr. Almond of the heart failure andtransplant program at Children’s Hospi-tal Boston.

HDEs and premarket approvals are sim-ilar in that each requires that safety stan-dards are met and each grants approval formarketing. However, HDEs only have toshow a probable benefit, whereas pre-market approvals require demonstrationof efficacy.

Pediatric devices bring a unique set of is-sues that have to be addressed in the reg-ulatory process, Dr. Almond said.

For example, the pediatric community

is less familiar with the FDA regulatoryprocess for high-risk medical devices thanis the adult device community. “One ofthe most important things we can do is tolearn as much as we can from the adultregulatory experience from selected cases”involving HDE, he said.

Smaller sample sizes in studies withchildren, the heterogeneity of the pedi-atric patient population in terms of size,anatomy, differences in drug metabolism,acuity, and types of circulatory support de-vices, and the potential for intense mediainterest because of the use of high-risk de-vices in fragile children are other uniqueconsiderations.

A device that is up for final review forHDE approval could be rejected becauseof legitimate concerns about its safetyand benefits. However, problems withthe study’s design or implementation alsocould render the data questionable, es-pecially if there are no P values to demon-strate the statistical significance of effi-cacy and safety data in the trials. Theseproblems would preclude “an accurate as-sessment of the probable benefit and rea-sonable safety of the device,” Dr. Al-mond said. “The goal is to make sure thatthe studies are well designed so that thereisn’t a problem with interpretability.”

When investigators seek an HDE for

their device as a bridge-to-transplant ther-apy in a clinical trial, they should focus onthe main end point of the trial, Dr. Al-mond advised. For HDE trials of pediatriccirculatory support devices, an end pointsuch as survival to transplant or recoveryor a surrogate end point such as survivalfor a fixed amountof time may givethe best evidence ofprobable benefit;less rigorous endpoints may not beas acceptable in suchtrials, he said.

Quality of lifedata can enhancethe interpretation ofoverall survival because it is possible for apatient to have a major intraoperativestroke but still survive in a comatose statefor several months after the surgery.

Most HDE trials have a single arm of10-50 patients who are enrolled at two ormore centers to increase the generaliz-ability of the results. The trial should in-clude reasonable stopping rules for pa-tient safety.

HDE trial investigators should use ob-jective inclusion and exclusion criteria toselect for the subset of patients in whomthe device will have the most benefit andbest safety. This is important because “anyfuture regulatory label will depend on theselection criteria for the device,” Dr. Al-mond said.

Careful documentation of how the pa-tients fulfill the selection criteria will alsohelp reviewers judge the device’s safety andrelative efficacy. For example, an HDE trialin which 10 of 20 patients survive at six cen-ters may raise reviewers’ concerns about theprobable benefit of the device. Their dis-

cussion would thenlikely focus on thetrial’s selection crite-ria. If the severity ofthe patients’ illness isnot evident, thenthey may not see anybenefit of the device,he said.

To make it easierto determine

whether a device is reasonably safe, it isprobably best to use commonly accepteddefinitions for adverse events, such as theNIH stroke scale, Dr. Almond said.

“This has been a problem in some ofthe adult regulatory trials where peoplehave shaved the definition to perhapsmake the device look a little safer,” hecommented.

Investigators can take several steps toensure that the results of an HDE trial aregeneralizable, he said. One center shouldnot dominate patient enrollment becauseit will be harder to conclude that the find-ings are generalizable to other centers. Itwould be easier to know the true risk ofadverse events such as stroke if the pro-tocols for the device—for example, anti-coagulation—do not vary substantiallyfrom center to center.

Dr. Almond suggested that much couldbe learned from the public record of theFDA’s Circulatory Systems Devices Panelmeeting in June 2005, in which the panelvoted not to recommend HDE approval ofthe AbioCor total artificial heart. TheAbioCor HDE trial, which included 14adult patients at 6 centers, assessed patientsurvival 60 days after implantation.

The trial investigators used conservativerules for stopping the trial for safety rea-sons—if the first 5 patients didn’t live forat least 30 days or if 2 of the first 10 pa-tients did not live for at least 60 days afterthe total artificial heart was implanted. ButFDA experts and panel members at themeeting did not approve the device be-cause of concerns about a high rate ofstroke and postoperative bleeding, unde-fined anticoagulation treatment protocols,and a lack of validated quality of life andfunctional data. ■

Defining the regulatory process for these devices will

entail the consideration of a unique set of issues.

Challenges Await Pediatric Circulatory Device Trials

Companies that are devel-oping a pediatric circula-

tory support device may notbe able to seek humanitariandevice exemptions if anoth-er company has already re-ceived an HDE for a similardevice and then supplantsthe HDE with a premarketapproval, Dr. Robert Jarviksaid during a discussion ses-sion at the FDA workshop.

Investigators of pediatriccirculatory support devicescould find themselves won-dering what kind of regula-tory approval to seek if a re-search group actually carriesout such an action, said Dr.

Jarvik, president and chiefexecutive officer of JarvikHeart Inc., New York.

Currently, HDE applicantsmust demonstrate that nocomparable device, otherthan another [humanitarianuse device] approved underthe HDE regulation or a de-vice being studied under anapproved [investigational de-vice exemption], is availableto treat or diagnose the dis-ease or condition,” accord-ing to the FDA. A device’smove from HDE to premar-ket approval (PMA) statusmeans that other deviceswith the same intended use

may lose or cannot obtainHDE status.

“Everybody’s plans andwhat they can afford isn’t go-ing to affect PMA. All ofthese programs are going tohave to go through HDE, orthey’re never going to beable to get [their device] outthere,” he said.

The decision of whetheror not to rescind a compa-ny’s HDE when a PMAcomes on the market is doneon a case-by-case basis, saidSheila Brown of the investi-gational device exemptionand humanitarian device ex-emption programs at the

Center for Devices and Radi-ological Health (CDRH).

“If we still find thatthere’s value to [an HDE],we have allowed someHDEs to stay on the marketeven though a PMA hasbeen approved,” Ms. Brownsaid.

“Another way to continuewith the HDE process is tohave a slightly different indi-cation for use,” she said.

“We are going to be verysensitive to this key topic inthis development area,” saidDr. Bram Zuckerman, direc-tor of the division of cardio-vascular devices at CDRH.

Premarket Approval Could Threaten Other HDE Requests

S A N F R A N C I S C O — Looks can be deceiving whenevaluating stenoses for treatment with stenting, Dr. JohnM. Hodgson said at a cardiovascular imaging conferencesponsored by the American College of Cardiology.

Not all stenoses detected on angiography are accom-panied by ischemia, and only patients with ischemianeed revascularization and stenting, said Dr. Hodgson ofSt. Joseph’s Hospital, Phoenix.

“Two-thirds of the time, when a patient comes to thecath lab we do not have any functional imaging,” he said.“We do not know for sure that the patient has ischemia.And then we’re left to interpret these fuzzy, two-dimen-sional angiograms.”

The patient could be sent out of the cath lab for func-tional imaging, but that’s inconvenient, and in many cas-es, the decision to attempt revascularization is madewithout the certainty that the anatomic lesion is ac-companied by a functional lesion. Now, the relativelynew technology of measuring fractional flow reserve(FFR) during catheterization could help physicians makebetter informed decisions about revascularization andstenting.

In FFR, a pressure transducer is sent into the coronaryartery, past the anatomic lesion. FFR is the transstenot-ic pressure gradient across a stenosis. It is measured atpeak blood flow after the administration of a vasodila-

tor (such as adenosine) and is indexed for aortic drivingpressure.

The result is a direct measurement of the influence ofa specific lesion on blood flow. Only when the FFR is 0.75or less, indicating a functional blockage of at least 25%,is stenting helpful.

The value of FFR was demonstrated in a prospectiverandomized trial, which indicated that not only is it safeto not revascularize stable lesions that don’t limit bloodflow more than 25%, but also that it provides better 24-month outcomes than does angiography (Circulation2001;103:2928-34).

—Robert Finn

Fractional Flow Reserve Can Inform Stenting Decisions

‘THE GOAL IS TO MAKE SURETHAT THE STUDIES ARE WELL

DESIGNED SO THAT THERE ISN’TA PROBLEM WITH

INTERPRETABILITY.’

MARCH/APRIL 2006 • T H O R AC I C S U R G E R Y N E W S DEVICES & TRIALS 19

CLINICAL TRIAL NEWSSurgery with adjuvant radiation therapy in

treating patients with stage I non–small

cell lung cancer will be evaluated in a ran-domized phase III trial comparing sublo-bar resection alone with resection plus in-traoperative brachytherapy.

The trial will be limited to those pa-tients who are considered to be at in-creased risk for a lobectomy, which is thecurrent standard of care for patients withstage I NSCLC. Sublobar resection is gen-erally considered a compromise opera-tion because of an increased risk of localrecurrence. Preliminary studies suggestthat added brachytherapy can reduce therisk of local recurrence close to that seenafter lobectomy. This phase III trial, co-ordinated by the American College ofSurgeons Oncology Group (ACSOG), isbeing performed to validate the results ofthese earlier studies. Patients in arm I willundergo open or thoracoscopic sublobarresection comprising either a wedge re-section or anatomical segmentectomy.In arm II, sublobar resection will also beperformed, but with the addition of in-traoperative brachytherapy.

In those patients randomized to re-ceive brachytherapy, iodine-125 seeds areimplanted at the wedge resection site.These seeds are available commerciallyand are already packaged and incorpo-rated onto vicryl suture. The seeds maybe implanted separately as paired suturelines or incorporated into a vicryl meshprior to implantation, according to Dr.Hiran C. Fernando, the protocol chair.

The primary objective is to comparetime to local recurrence, defined as re-currence in the same lobe or in hilar (N1)nodes, or progression at the staple line.Secondary objectives include an analysisof procedure-specific morbidity and mor-tality between the two treatment armsaimed at comparing overall and failure-free survival of these patients, comparingfreedom from regional or distant recur-rence, and determining the effect of his-tologically or cytologically positive re-

section margins on the time to local re-currence in these patients. The study willalso seek to determine the effect ofbrachytherapy on quality of life and pul-monary function. After study treatment,patients will be followed at 3 months, 6months, and then every 6 months for 2.5years, and then annually for 2 additionalyears, said Dr. Fernando, a thoracic sur-geon at Boston Medical Center.

This randomized, multicenter clinicaltrial is sponsored by the American Collegeof Surgeons and the National Cancer In-stitute. The study is recruiting patients andexpects a total enrollment of 226 patients(113 per treatment arm) over the next 3years, with a completion date in 2010.

Patient eligibility criteria include histo-logically or cytologically proven NSCLC,no metastases, and clinical stage IA and se-lected IB (T2 by visceral pleural involve-ment and tumor size of 3 cm or smaller)cancer with no evidence of nodal in-volvement by CT and PET. Patientsshould meet at least one of two majorcriteria or a minimum of two minor cri-teria to be considered high risk. The ma-jor criteria are an FEV1 (forced expirato-ry volume in 1 second) less than 50% anda DLCO (diffusion capacity of carbonmonoxide) less than 50%. Minor criteriainclude an age of 75 years or younger,pulmonary hypertension, an oxygen re-quirement, congestive heart failure, anda dyspnea score of 3 or greater.

“This trial is important in a couple ofways to thoracic surgeons. First, it tests animportant additional therapy for patientswith lung cancer and risk factors thatmake a lobectomy impossible. Second, thetrial comes at a crucial time for the AC-SOG. The extent to which thoracic sur-geons rally and offer this trial to appro-priate patients may very well helpdetermine the fate of the cooperativegroup in the future,” said Dr. Bryan Mey-ers, a surgeon at the Siteman Cancer Cen-ter, Barnes-Jewish Hospital, St. Louis, andone of the trial investigators. ■

Pediatric Support DevicesA Model for Other Types

B Y J E F F E VA N S

Else vier Global Medical Ne ws

R O C K V I L L E , M D. — The developmentand clinical testing of pediatric circulatorysupport devices could guide the regulato-ry process of other high-risk pediatric de-vices, said speakers at a meeting sponsoredby the Food and Drug Administration.

“From our perspective at the FDA,we’re committed to developing innovativeways to spur pediatric device develop-ment,” said Dr. Bram D. Zuckerman, di-rector of the division of cardiovascular de-vices at the Center for Devices andRadiological Health. The FDA is trying tocollect information on the reasons behindthe limited availability of pediatric devicesand on how the regulatory process forstudying and approving such devices can bestreamlined. In 2004, the agency asked forcomments from 1,600 interested parties—including consumers, the medical device in-dustry, researchers, health care practition-ers, and professional and tradeassociations—for a report to Congress, butonly 24 replies were received. In its reportto Congress, the FDA noted that a varietyof medical specialties identified unmetneeds, including pediatric circulatory sup-port devices, but the full scope of thoseneeds was not known. The FDA con-cluded it was too early to recommend anypolicy, regulatory, or legislative changes.

Pediatric clinical data are needed whena device is indicated for children and datafrom bench, animal, or adult studies arenot available, relevant, or sufficient. De-sign modifications to an existing device ornew treatment regimens also require pe-diatric clinical data, according to an FDAguidance document on premarket assess-ment of pediatric medical devices.

The enrollment of children in clinicaltrials is often limited by a low prevalence

of disease, concerns about exposure to ad-ditional testing, and the reluctance of par-ents, clinical investigators, and institu-tional review boards. In many cases, it isharder to get compliance with the studyprotocol and to get adequate follow-up.

Most of the groups that are developingpediatric circulatory support devices willseek to designate them as a humanitarianuse device (HUD) because of the lowercosts associated with the HUD regulato-ry process, lack of an efficacy requirementfor approval, and the fact that such devicesare intended to benefit fewer than 4,000patients per year in the United States, saidDr. Sarah R. Linde-Feucht, director of the

HUD designation program in the Office ofOrphan Products Development.

Investigators who seek to designate theirhigh-risk (class III) device as a HUD willseek a humanitarian device exemption(HDE) rather than a premarket approval(PMA). Although HDEs and PMAs aremarketing approvals, companies can prof-it only from PMAs; companies that pro-duce HDE devices can only recover theircosts. PMAs and HDEs require demon-stration of a reasonable level of safety. APMA must prove the effectiveness of a de-vice, but an HDE must only show a prob-able benefit. Since 1996, there were 165requests for HUD designation, but only 39devices have been approved through anHDE, Dr. Linde-Feucht said. ■

‘FROM OUR PERSPECTIVE AT THEFDA, WE’RE COMMITTED TO

DEVELOPING INNOVATIVE WAYSTO SPUR PEDIATRIC DEVICE

DEVELOPMENT.’

C L A S S I F I E D SA l s o Av a i l a b l e a t w w w. e l s e v i e r h e a l t h c a r e e r s . c o m

PROFESSIONALOPPORTUNITIES

Need QualifiedJ-1; H1-B; AT; ABAT

2006/07 Doctors Now!

Elite speed search:

Approved locations & employment contracts

Nationwide Since 1985

Physician Alliance Group

5189 Ridge Heights Street

Las Vegas, Nevada 89148

800.306.1950

doctor@lvcm.com

usmf.net

fx: 702.226.9237

BEST READERSHIP, LOW COSTQUALIFIED LEADS

2006 CLASSIFIEDS

For Deadlines and More Information Contact: Robin Cryan Tel: 1-800-379-8785 or fax your ad to 212-633-3820

Email ad to: r.cryan@elsevier.com

Thoracic Surgery NewsElsevier-Thoracic Surgery News360 Park AvenueNew York, NY 10010

Thoracic Surgery News Rates4 Column Classified Ads

From 1” to 12”Sizes from 1/48th of a page

to a full page

DisclaimerTHORACIC SURGERY NEWS assumes the statements made in classified advertisements are accurate, but cannot investigate the statements and assumesno responsibility or liability concerning their content. The Publisher reserves the right to decline, withdraw, or edit advertisements. Every effort willbe made to avoid mistakes, but responsibility cannot be accepted for clerical or printer errors.