Lung Volume Reduction Surgery Benefits BODE

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Lung Volume Reduction Surgery Benefits BODE

  1. 1. B Y R O B I N S E AT O N J E F F E R S O N Elsevier Global Medical News ST. LO U I S — A review of 250 consecutive patients who un- derwent bilateral lung volume reduction surgery for emphyse- ma showed improvement in res- piratory mechanics associated with reduction in hyperinflation, producing significant palliative benefit for patients, according to Dr. Joel D. Cooper at a thoracic surgery meeting sponsored by Washington University. Dr. Cooper reported that the 90-day and complete hospital mortality was 4% in the series of patients treated at Barnes-Jewish Hospital in St. Louis between January 1993 and June 2000. There were no intraoperative deaths. Follow-up ranged from 2 years to 9 years, with a medi- an of 4 years. Only one patient was lost to follow-up; 96 of the 250 patients died, most of them from respiratory failure. The forced expiratory volume in 1 second (FEV1) and the resid- ual volume (RV) “showed a sta- tistically significant improve- ment between preoperative values and each time point of follow-up. There was no statisti- cal significance between initial evaluation 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 mm Hg at the 6-month, 1-year, and 3- year follow-ups and of 5 mm Hg at 5 years. Also, 79% of patients had improved at 3 years and 66% at 5 years, he said. Dr. Cooper said supplemental oxygen 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 Volume Reduction Surgery Benefits BODE B Y B R U C E K . D I X O N Elsevier Global Medical News MO N T R E A L — Lung volume reduction surgery improves the BODE index, a composite prog- nostic model that denotes dis- ease severity in patients with chronic obstructive pulmonary disease, as shown by a small study presented at the annual meeting of the American Col- lege of Chest Physicians. This means that changes in the BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index might be promising as markers for predicting surgical out- come in chronic obstructive pulmonary disease (COPD) patients, according to Dr. David J. Lederer of New York–Presbyterian Hospital in New York. If the appropriate factors that predict change in the BODE in- dex could be identified, in the future, measurements might be done on a patient to determine if surgery was appropriate based upon BODE, Dr. Leder- er said in an interview. “That re- search is two or three studies away and we have to [first] see that changes in BODE predict outcomes, and then we have to find the baseline characteristics that predict the change in BODE.” This approach is an out- growth of the National Em- physema Treatment Trial (NETT), which found that lung volume reduction surgery (LVRS) improved survival, as well as exercise capacity and quality of life in a subset of pa- tients who have severe emphy- sema. The data showed that: Ǡ Participants with mostly up- per-lobe emphysema and low exercise capacity were more likely to live longer and more likely to function better after LVRS than after medical treat- ment. Ǡ Those with mostly upper- lobe emphysema and high ex- Endovascular Skills Are Becoming Essential B Y B R U C E K . D I X O N Elsevier Global Medical News CH I C AG O — Percutaneous in- terventions continue to replace conventional surgical repair, and the future for cardiothoracic sur- geons lies in catheter-based train- ing and intervention, said Dr. Tomas A. Salerno at the annual meeting of the Society of Tho- racic Surgeons. His remarks echo those by Dr. Grayson H. Wheatley III, who said that if cardiothoracic sur- geons don’t learn interventional skills, those skills would be lost to other specialties that already have the upper hand. Procedures such as patent duc- tus, coarctation, atrial septal defect and various congenital defects, peripheral vascular surgery, and pacemakers have slipped between the fingers of cardiothoracic sur- geons “just because of our lack of catheter and interventional skills,” said Dr. Wheatley, a cardiovascu- lar surgeon with the Arizona Heart Institute in Phoenix. “For cardiac surgeons, en- dovascular skills represent ‘the road less traveled,’” he said. “Just imagine if, early on, we had in- corporated endovascular skills into our practices and in the training programs of cardiac surgery residents; I think endo- luminal stenting would now be an integral part of most of our cardiothoracic practices, and we would be doing a whole lot of stenting throughout the body.” The situation is compounded COURTESYDR.TOMASA.SALERNO Dr. Tomas A. Salerno moderated a symposium on the key role of stenting held at the Society of Thoracic Surgeons annual meeting. LVRS for Emphysema Shows Promise See LVRS • page 7 News Residents’ Evil STS panel discusses finding graduates the right jobs. • 3 At Odds Surgeons think the quality of teamwork in the OR is good, but other staff disagree. • 6 Congenital Heart Migraine Blocker Some 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’ Stuff Defining 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 Standard U.S. Postage PAID Permit No. 384 Lebanon Jct. KY THORACIC SURGERY NEWS 12230 Wilkins Avenue Rockville, MD 20852 CHANGE SERVICE REQUESTED See Emphysema • page 9 Men Still Outnumber Women in Thoracic Surgery 16 167 1,106 1,438 1,183 856 69 62 17 2 Note: Based on 4,750 male thoracic surgeons and 166 female thoracic surgeons in the United States in 2004. Source: American Medical Association Women Men ͧ65 years55-64 years 45-54 years 35-44 years <35 years V I T A L S I G N S RICHARDFRANKI/ELSEVIERGLOBALMEDICALNEWS
  2. 2. MARCH/APRIL 2006 • THORACIC SURGERY NEWS NEWS 3 THORACIC SURGERY NEWS AMERICAN 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 Association for Thoracic Surgery and provides the thoracic surgeon with timely and relevant news and commentary about clinical developments and about the impact of health care policy on the profession and on surgical practice today. Content for THORACIC SURGERY NEWS is provided by the Elsevier Society News Group and Elsevier Global Medical News. Content for the News From the Association is provided by the American Association for Thoracic Surgery. The ideas and opinions expressed in THORACIC SURGERY NEWS do not necessarily reflect those of the Association or the Publisher. The American Association for Thoracic Surgery and Elsevier Inc. will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein. POSTMASTER: Send changes of address (with old mailing label) to Circulation, THORACIC SURGERY NEWS, 12230 Wilkins Ave., Rockville, MD 20852. The American Association for Thoracic Surgery headquarters is located at 900 Cummings Center, Suite 221-U, Beverly, MA 01915. THORACIC SURGERY NEWS (ISSN 1558-0156) is published bimonthly for the American Association for Thoracic Surgery by Elsevier Inc., 60 Columbia Rd., Bldg. B, Morristown, NJ 07960, 973-290-8200, fax 973-290-8250. ELSEVIER SOCIETY NEWS GROUP President, IMNG Alan J. Imhoff Director, ESNG Mark Branca Executive Director, Editorial Mary Jo M. Dales Executive Editor, IMNG Denise Fulton Executive 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, fax 267-893-5682, severly@ki-lipton.com Classified Sales Manager Robin Cryan, 800-379-8785, fax 212-633-3820, 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, NJ 07960, 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 Elsevier Global Medical News C H I C AG O — Lack of quality job oppor- tunities is the primary concern for thoracic surgery residents, according to exit surveys from last year’s Society of Thoracic Sur- geons annual meeting, said Dr. John R. Mehall, president of the Thoracic Surgery Residents Association. For this reason, the residents met at this year’s STS meeting to discuss “Today’s Job Market: How to Look and What’s in De- mand.” “The effects of declining cardiac case volumes, declining reimbursements, and a declining stock market combined to create a situation where hiring was scarce and re- tirements were postponed,” Dr. Mehall said in an interview. “As a result, many graduating cardio- thoracic residents could not find quality Employment Remains a Key Issue for Residents practice opportunities, or in some cases, 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 of surgeons who recently hired new graduates was assembled to discuss why they hired new residents, what they were looking for, and how they went about the process. Panel mem- bers included Dr. A. Michael Borkon, the MidAmerica Heart In- stitute, Kansas City, Mo.; Dr. John H. Calhoon, the University of Texas Health Science Center, Houston; Dr. W. Randolph Chitwood Jr., East Carolina University, Greenville, N.C.; Dr. Joseph N. Cunningham, Maimonides Medical Center, Brook- lyn, N.Y.; Dr. Kim F. Duncan, the University of Nebraska Medical Center, Omaha; and Dr. Joseph F. Sabik III, the Cleveland Clinic Founda- tion. In response to tales of unemployment and underemployment presented by resi- dents in the audience, the panel empha- sized networking to find new jobs, not merely answering classified ads. Almost all hiring, the panelists agreed, was done on the basis of recommendations from peo- ple who were known and respected by the employing surgeon. Specialized training was also emphasized by several of the pan- el members, who pointed out that they tended to hire surgeons to fill specific roles and selected individuals with the de- sired expertise. There is another reason for the current poor job market. According to one pan- elist, the eligible pool not only includes residents but also midlevel cardiac sur- geons let go for financial reasons in prac- tices across the United States, who are looking 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 cardiothoracic surgery into new areas such as arrhythmia surgery, the reality of a steadily increasing population of aging patients, and an in- crease in retiring surgeons should signifi- cantly improve the overall situation for young surgeons,” he said. “As these trends continue, some are even 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 residents training in programs throughout North America. The association has representa- tives working with all major professional organizations within thoracic surgery to improve surgical education and training. In addition to the residents’ luncheon at the annual STS meeting, TSRA is planning a residents-only Cardiothoracic Technol- ogy Symposium in May, Dr. Mehall said. For more information, visit www. ctsymposium.org or see page 12 of this newspaper. s Dr. John R. Mehall is the current president of the Thoracic Surgery Residents Association. COURTESYDR.JOHNR.MEHALL Panel discussion at the STS annual meeting sees mixture of hope and gloom in resident hiring. NEWS • 3 The new SPECT guidelines could extend beyond quality to include cost-effectiveness and efficiency, 4 GENERAL THORACIC • 7 Adding acetylcysteine to the stan- dard treatment for pulmonary fibro- sis slows its progression, 8 Endoscopic ultrasound beats PET in staging lymph nodes, 8 CARDIOPULMONARY TRANSPLANT • 1 0 Cardiac interventions do not increase lung transplant risks. GERD surgery may lower rejection risk rates in lung transplant patients. CONGENITAL HEART • 11 Pregnancy in women with isolated congenital pulmonary valve stenosis is associated with obstetric and fetal complications. ADULT CARDIAC • 1 5 Using NSAIDs in patients who’ve had an acute MI raises the risk of mortality, says a Danish study. BASKET trial researchers say rou- tine use of drug-eluting stents is not cost effective, 17 DEVICES & TRIALS • 1 8 Development of pediatric circulato- ry support devices could guide the regulatory 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.
  3. 3. 4 NEWS THORACIC SURGERY NEWS • 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 KEVINFOLEY/ELSEVIERGLOBALMEDICALNEWS Cultures Fail to Predict Postsurgical Mediastinitis in Heart Patients WA S H I N G T O N — Sternal wound and mediastinal tissue cultures are not effective predic- tors of postsurgical mediastinitis in heart surgery patients, wrote Dr. Emilio Bouza in a poster pre- sented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. Dr. Bouza and his colleagues at the Hospital General Univer- sitario Gregorio Marañón in Madrid conducted a prospective study of 227 patients undergo- ing 229 sternotomies for heart surgery in order to assess the va- lidity of postsurgical cultures in predicting mediastinitis. Medi- astinitis—defined in this study as purulent discharge associated with either partial or complete sternal dehiscence—has been as- sociated with prolonged hospi- tal stays and mortality rates ranging from 6% to 19%. A total of seven patients de- veloped postsurgical mediastini- tis 11 days after surgery. In these patients, five of the semiquanti- tative mediastinal fluid cultures and three of the quantitative cul- tures were sterile, and the re- maining cultures contained mi- croorganisms different from those that caused the infections. In the 220 patients (222 proce- dures) who did not develop post- surgical mediastinitis, 31% of semiquantitative mediastinal cul- tures and 34% of quantitative cultures were positive. Conse- quently, the investigators do not recommend intraoperative cul- tures for heart surgery patients. The meeting was sponsored by the American Society for Mi- crobiology. —Heidi Splete B Y R O B E R T F I N N Elsevier Global Medical News D riven by concerns over the rising cost of cardiovascular care and looming pay-for-performance rules, a techni- cal panel convened by the American Col- lege of Cardiology Foundation and the American Society of Nuclear Cardiology has released the first set of appropriateness criteria for a cardiac-imaging modality. The panel considered which of 52 clin- ical scenarios were appropriate indications for single-photon emission computed to- mography myocardial perfusion imaging (SPECT MPI), which were inappropriate indications for SPECT, and which were un- certain indications (J. Am. Coll. Cardiol. 2005;46:1587-605). The criteria have been endorsed by the American Heart Association. The panel judged SPECT to be a gener- ally acceptable and reasonable approach in 27 of the clinical scenarios. These included evaluation of asymptomatic patients with high Framingham risk of coronary heart disease (CHD), asymptomatic patients with coronary calcium scores of 400 or greater, and patients with chest-pain syndrome and a high pretest probability of coronary artery disease who are unable to exercise or who 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 asymptomatic patients with low Framingham risk of CHD and asymptomatic patients with car- diac calcium scores less than 100; it was also unacceptable for preoperative risk as- sessment of noncardiac surgery patients. The remaining 12 scenarios were those that may be generally acceptable and may be a reasonable approach, but for which ad- ditional data are necessary. These included evaluations of asymptomatic patients with moderate Framingham risk of CHD, asymptomatic patients diagnosed with stenosis of unclear significance after CT angiography, and asymptomatic patients for the first 5 years post revascularization. The authors of the criteria recom- mended that third-party payers should def- initely reimburse for the appropriate and uncertain indications, but that reimburse- ment for indications judged inappropriate should require a documented exception from the physician ordering the study. “These new technologies are terrific,” said Dr. Ralph G. Brindis, chair of the ACCF appropriateness criteria working group. “They offer new advances in diag- nosis and treatment. But we need to be able to use them in the appropriate set- tings, [with] the right patient at the right time and for the right indication.” Dr. Brindis, a cardiologist from Oakland (Calif.) Kaiser Medical Center, said that the cost of care was one of the main motiva- tions for considering appropriateness cri- teria for SPECT. “I think we owe it to our patients and to the cardiovascular com- munity as a whole to better get our hands on the burgeoning costs of cardiovascular care,” he said in an interview with this newspaper. Funded by almost $1 million from ACCF, future panels will consider other imaging modalities, including CT, MRI, and echocardiography. Dr. Brindis said that he cast a wide net when recruiting the 12 members of the technical panel. In addition to specialists in nuclear cardiology, the panel included gen- eral cardiologists, experts in echocardiog- raphy, an outcomes researcher, and the chief medical officer of a health insurance provider. 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 to identify 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 in a time frame to fit the already-begun process. It certainly wasn’t a snub of the process, because we applaud these efforts even though we have some differences in the way we approach them. I think over- all it was a well-constructed document.” The ACR has developed appropriateness criteria for 170 clinical indications since their first in 1993. Their approach is to take a clinical indication, such as chest pain, and rank the available tests in terms of what would be the most appropriate. “When you just do it from a modality approach, it doesn’t tell you whether SPECT my- ocardial perfusion imaging is preferable to echocardiography or to a simple stress test, which is a lot cheaper,” Dr. Guib- erteau said. The ACC has already provided such a ranking in its clinical practice guidelines, countered Dr. George A. Beller, the Ruth C. Heede Professor of Cardiology and professor of internal medicine at the Uni- versity of Virginia, Charlottesville, who was not involved in developing the ap- propriateness criteria. Dr. Beller said he found few surprises in his reading of the SPECT appropriateness criteria. “Where I think it might be useful is for reinforcing the clinical practice guide- lines for primary care physicians so they would have a better feeling for who they might 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 of the quality arena and will include areas such as cost-effectiveness and efficiency,” he said. And he’s pleased with the reception the new appropriateness criteria have received. “I’ve had nuclear cardiologists tell us this is too restrictive, and I’ve had some acad- emic nonnuclear cardiologists saying we didn’t go far enough,” he said. “If we [failed to make] both sides happy, that means we must be pretty close to the truth.” s Appropriateness criteria may eventually go beyond quality to include cost-effectiveness and efficiency. Panel Releases Criteria for SPECT WE NEED TO BE ABLE TO USE CARDIAC IMAGING WITH ‘THE RIGHT PATIENT AT THE RIGHT TIME AND FOR THE RIGHT INDICATION.’ B Y E L I Z A B E T H M E C H C AT I E Elsevier Global Medical News T he potential for interactions with cyclosporine was one of the main safety concerns expressed by a federal advisory panel supporting ap- proval of nonprescription availability of the weight loss drug orlistat. At a joint meeting of the Food and Drug Administration’s nonprescription drugs advisory committee and the en- docrinologic and metabolic drugs advi- sory committee in January, panel mem- bers voted 11-3 in favor of making 60-mg capsules of orlistat available over the 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 as a contraindication in the current label. Orlistat works locally in the GI tract to prevent absorption of up to 30% of dietary fat. However, cyclosporine ab- sorption is decreased when taken with orlistat, 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 for nonprescription orlistat warns not to use orlistat if taking cyclosporine, or “a drug given after organ transplant.” GlaxoSmithKline officials referred to 44 reports of people on cyclosporine who took orlistat, which included 38 cases with low cyclosporine serum lev- els. Of these cases, 2 patients had issues with their grafts, but were treated suc- cessfully. In several cases reviewed by the FDA, serum cyclosporine levels dropped rapidly when orlistat therapy was start- ed and fell to subtherapeutic levels. s Cyclosporine Interacts With Weight Loss Drug
  4. 4. 6 NEWS THORACIC SURGERY NEWS • MARCH/APRIL 2006 by weaknesses in cardiothoracic surgery training programs and parallel declines in applications 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 in the United States, you see that there is a whole bunch of lung, esophagus, con- genital heart disease, adult cardiac and even pacemakers, and bronchoscopy and esophagoscopy; but the number of en- dovascular procedures currently required by the American Board of Thoracic Surgery is zero, and I think that needs to change, both for our specialty and our abil- ity to offer our best to patients,” he said. Between 1993 and 2006, applications to thoracic surgery resident programs dropped from more than 180 to about 120. In addition, 2005 was the first year that the number of applicants was lower than the number 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 Medical Center, said cardiothoracic surgeons at the University of Miami “no longer open the chest for thoracic aortic diseases, and we 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 future development.” He warned that failure to develop stenting expertise will hasten the transfer of thoracic aneurysm treatment from cardiothoracic surgeons to cardiac in- terventionalists, a situation that already is evident in coronary artery stenting. “One of the important aspects of this in- ternational symposium ... is discussing the new role that cardiothoracic surgeons are playing in the treatment of aortic dis- eases utilizing the percutaneous approach. Rather than delegating this procedure to interventional cardiologists, cardiac sur- geons are recognizing that the time has come to lay their hands on catheters and to 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 the future of cardiovascular surgery, he added. “At our center, fellows have been fortunate to have an opportunity to work with both cardiologists and surgeons in the en- dovascular treatment of thoracic diseases.” The number of formal endovascular fellowships 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 and research and we need to have more hands- on catheter and guidewire courses. If you have the catheter and guidewire skills to do thoracic endografting, then you will be a prime candidate for getting involved in percutaneous valve technology.” Because most patients with thoracic aortic disease will have peripheral vascu- lar disease, “we need to be able to do stent- ing or balloon angioplasty to become complete cardiovascular specialists,” he said, explaining that carotid stenting also is an opportunity for thoracic surgeons al- ready working on the aortic arch. “A lot of our patients have combined carotid/CABG procedures, so why not be the ones doing the carotid stenting? Why yield that to our colleagues?” said Dr. Wheatley. “[Almost all] current cardiovascular pathology will be treated by endovascular procedures in the future. But it’s not go- ing to be by the classic cardiac surgeon ... it’s going to be vascular specialists or the cardiovascular specialists who have inte- grated catheter and wire skills into their practices,” 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 he performed his first endovascular procedure in 1964, Dr. Dotter made what Dr. Wheat- ley considers a prescient remark: “The an- giographic catheter can be more than a tool for passive means for diagnostic observa- tion; used with imagination, it can become an important surgical instrument.” s Endovascular Training Needed Essential Skills • from page 1 B Y B E T S Y B AT E S Elsevier Global Medical News SA N FR A N C I S C O — Surgeons view collaboration, communica- tion, and teamwork in their oper- ating rooms through rose-colored glasses, in sharp contrast to the perspective of nurses and techni- cians working alongside them, ac- cording to survey results present- ed by Dr. Martin Makary at the annual clinical congress of the American College of Surgeons. “We think we’re doing a great job.” But the nurses, anesthesiol- ogists, and technicians “see some problems that we don’t see,” said Dr. Makary, who serves on the faculty of the departments of surgery and public health at Johns Hopkins University in Baltimore. Dr. Makary surveyed 2,135 sur- gical team members, including surgeons, anesthesiologists, certi- fied registered nurse-anesthetists, scrub nurses, and technicians, about social dynamics in the op- erating room that have been proven to affect surgical out- comes. Surgical team members who were surveyed worked in 60 hospitals across 16 states, said Dr. Makary, who also represents the surgery department in the uni- versity’s center for innovation in quality patient care. He found that surgeons rated the 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 fellow surgeons at 85, anesthesiologists at 84, and nurses at 87. Nurses rated surgeons at 48, and anesthesiologists rated sur- geons at 70. Furthermore, Dr. Makary found significant discrepancies among surgeons, anesthesiolo- gists, and others in the OR in how they responded to statements such as “I have the support I need from other personnel in caring for patients,” “It is easy to ask questions,” and “We work well to- gether as a coordinated team.” Surgeons generally thought all was well, whereas other team members disagreed. “This is a topic that speaks to the issue of a nurse in the OR know- ing that a sponge is retained in the abdomen but not saying anything because of the hierarchy that we have espoused” throughout the history of our profession, Dr. Makary said. “It speaks to the nurse in the OR realizing that a pa- tient is receiving an organ with the wrong blood type but not saying anything because the last time she did she was criticized.” The stakes are high, he emphasized. A study by the Joint Commis- sion on Accreditation of Health- care Organizations found that communication was the root cause of more than 60% of “sen- tinel events” in hospitals, Dr. Makary said. For example, com- munication failures can be traced to 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 study contained a “pretty serious mes- sage . . . about the communication disconnect in operating rooms.” A cardiothoracic surgeon who now works with the Veterans Af- fairs national center for public safety, Dr. Dunn said a first step in making 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 their input has value, then they also don’t believe they’re members of a team and won’t participate as such, he said. After a study of 7,000 adverse incidents in the VA revealed that 78% were due to failed commu- nication, the VA decided to take communication seriously. The VA has been closing ORs for 1 day to conduct a peer-to-peer team training program in which colleagues interactively discuss nine filmed clinical vignettes that depict various barriers to collabo- ration and communication. The training is being administered in operating rooms throughout much of the VA system. Studies of the effectiveness of the training program are ongo- ing, but they seem to indicate that establishing rules of conduct and talking as a team are central elements for improved commu- nication, Dr. Dunn said. s Perceptions of Teamwork in the Operating Room Differ Sharply Heart Patient Gets $5 Million in Fraud Case B Y J O Y C E F R I E D E N Elsevier Global Medical News AMaryland jury has awarded $5 million to a heart surgery patient who claimed that a cardiology group misled him into believing that his heart surgeon—who was not a member of the group—was unavailable to perform bypass surgery. As a result, the patient was operated on by a different surgeon and experienced com- plications that required him to undergo additional procedures. The Baltimore County jury found that two physicians with Midatlantic Cardiovascular As- sociates—cardiac surgeon Dr. Jeffrey E. Sell and Dr. Mark Midei, cardiologist and director of the cardiac catheterization laboratory at St. Joseph Med- ical Center, Towson, Md.— committed fraud by steering the patient, Harry Bargar, to Dr. Sell, who was employed by the practice, rather than to Dr. Peter Horneffer, who had previously operated on Mr. Bargar. The jury also found Dr. Sell guilty of battery for operating on Mr. Bargar without having valid consent to do so. The jury awarded Mr. Bargar and his wife $2.25 million in compensatory damages, to be paid by the two doctors and Midatlantic. It also awarded the couple another $2.75 million in punitive damages, to be paid by Midatlantic. Dr. Horneffer is a member of Cardiac Surgery Associates (CSA), Towson, a rival cardiac surgery practice. When Midat- lantic was adding cardiac sur- geons to its roster as part of its transformation into a multi- specialty cardiology group, CSA was invited to merge with Midatlantic. CSA declined, and its referrals from Midatlantic dropped precipitously once Midatlantic recruited other car- diac surgeons. William F. Gately, attorney for the Bargars, said the verdict was “thoroughly and entirely appropriate. For any physicians to do to a patient what this jury found 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 has filed against Midatlantic, charg- ing it with “unfair bargaining power over health care providers” and accusing it of violating federal antikickback laws in connection with de- mands it made of CSA during merger negotiations. That suit is still pending. Linda Harder, spokeswoman for Midatlantic, said the com- pany plans to appeal the ver- dict in the Bargar case. “Our physicians would nev- er, ever mislead a patient, and they didn’t in this case,” she said. “Midatlantic has referred about 10,000 patients for car- diac surgery in the last 5 years. Only about 75% were referred to Midatlantic surgeons, and the other 25% were referred to other surgeons. They would always strive to honor a pa- tient’s wishes in terms of heart surgery.” s ESTABLISHING RULES OF CONDUCT AND TALKING AS A TEAM ARE CENTRAL ELEMENTS FOR IMPROVED COMMUNICATION.
  5. 5. MARCH/APRIL 2006 • THORACIC SURGERY NEWS GENERAL THORACIC 7 ercise capacity had no difference in sur- vival between the LVRS and medical groups, but those in the surgical group were more likely to function better than were those who received medical treat- ment. Ǡ Patients with mostly non–upper-lobe emphysema and low exercise capacity had similar survival and exercise ability after LVRS as after medical treatment, but had less shortness of breath. Ǡ Participants with mostly non–upper- lobe emphysema and high exercise capac- ity had poorer survival after LVRS than af- ter medical treatment, and LVRS and medical participants had similar low chance of functioning better (N. Engl. J. Med. 2003;348:2059-73). The following year, Spanish researchers published a study suggesting that the BODE 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. Lederer and 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 over 15 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, while 16 had upper-lobe emphysema and high exercise capacity, as defined by NETT. The group underwent LVRS after com- pleting pulmonary rehabilitation. “The vast majority were using inhaled corticosteroids and long-acting bron- chodilators. About half were using tiotropium and the rest were using ipra- tropium. Oxygen was used by 57% and the median modified Medical Research Coun- cil dyspnea score was 3,” said Dr. Leder- er. He added that 14 patients underwent bilateral thoracoscopic LVRS, while 9 un- derwent median sternotomy. “Our median length of stay was 8 days in the hospital and 2 days in the ICU. There were no deaths perioperatively or at follow-up. Prolonged air leak, which was not unexpected, occurred in 39% of pa- tients. There was one episode each of pneumonia, infected pleural space, ar- rhythmia, and excessive transfusion,” Dr. Lederer said. Among the 12 patients for which 6-month data are avail- able, forced vital capacity in- creased from 54% to 71% pre- dicted; forced expiratory volume in 1 second (FEV1) in- creased from 26% to 35% pre- dicted; and total lung capacity improved from 121% to 106%,” Dr. Lederer said. “The total lung capacity ra- tio, which recently was shown to be a prognostic indicator in patients with COPD, improved from 22% to 33%. And it’s im- portant to note that diffusion capacity of carbon monoxide, though it did not increase sig- nificantly, did not go down either. Maxi- mum exercise capacity increased from 36 to 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 of 3 to a median of 1,” he said, adding that these findings are consistent with those of NETT. “LVRS works in the real world, not just in a randomized trial, and it sets the stage for our finding that LVRS improved the BODE index. The median BODE index prior to surgery was 5, placing the patients in the third quartile with a predicted 4-year mortality of 40%. Six months after surgery, the BODE index decreased to a median of 2.5, which placed them some- where between the first and second 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 median of 3 to a median of 2, and im- provements in dyspnea from a median of 2 to 0.” Allowing for the study’s lim- itations, including its “small sample size and only 6-month follow-up,” Dr. Lederer con- cluded that it did show that LVRS improves BODE index, “and from the NETT study we know that LVRS improves survival, but what we need to determine with more research is whether changes in the BODE index are predictive of the magnitude of benefit down the road.” If that proves to be the case, Dr. Leder- er sees enormous potential for the index, predicting that, in addition to helping physicians select COPD patients for surgery, it will facilitate research into new interventions for COPD. By tracking changes in BODE scores, investigators would be able to predict outcomes with- out enrolling thousands of patients. s BODE Index Improvement LVRS • from page 1 We need to determine if changes in BODE predict the amount of benefit down the road. DR. LEDERER B Y B R U C E K . D I X O N Elsevier Global Medical News MO N T R E A L — Physicians should not exclude a diagnosis of pulmonary embolism based on arterial blood gas analysis, ac- cording to a study presented at the annual meeting of the Amer- ican College of Chest Physicians. “Instead, they should continue to rely on D-dimer and clinical prediction models, such as the Wells criteria, or go on to diagnostic imaging,” said Dr. Tara Keays of the University of Ottawa Hospital. Researchers have tried to come up with bedside investi- gation tools to rule out this common and lethal disease without the need for more invasive and ex- pensive diagnostic imaging prior to the initiation of anticoagula- tion therapy. The most successful results in- volve blood testing for D-dimer, a fibrin degradation product that is produced only after a clot has formed and is in the process of being broken down, in combina- tion with a clinical algorithm. (See box.) Recently, initial studies com- bining D-dimer with arterial blood gas (ABG) values as a di- agnostic method showed im- pressive negative predictive val- ues, but efforts to validate those results have been unsuccessful. In the retrospective study presented by Dr. Keays, her team investigated the role of ABG and D-dimer values using data from a double-blind, randomized con- trolled trial compar- ing bedside diagnos- tic tests with ventilation/perfusion (V/Q) scanning in the exclusion of suspect- ed pulmonary em- bolism (PE). “In the derivation study, PE was exclud- ed if two of the three bedside studies were negative; the V/Q scan was normal or near normal; or the patient was not started on anticoagulation at the end of the investigation. PE was confirmed by a high- probability V/Q; by low or in- termediate probability V/Q along with another diagnostic modality being positive; on au- topsy; or if anticoagulation was started by the end of the investi- gation,” Dr. Keays said. Patients were excluded from the study if they were aged younger than 18 years, had a sus- pected survival of less than 3 months, were ventilated, had known chronic PE, were on an- ticoagulation, or had vena caval interruption. Of the 824 patients screened, 458 were eligible and 399 con- sented, and 278 had ABG drawn initially. Of the total cohort of 399 patients, 14% were diag- nosed with PE. “Looking at the continuous ABG values, there was no signif- icant difference in the mean PaCO2, 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. Keays explained. “Our clinical prediction rule simply states that PE is possible if D-dimer is positive or if the D- dimer is negative and there’s an abnormal PaCO2 and an abnor- mal Aa gradient,” she said. The negative predictive value and sensitivity of the rule were 100%, 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 findings in a retrospective secondary analysis of 246 patients was not as clear-cut. This study produced a negative predictive value of 91%, a sensitivity of 89%, and a true negative proportion of 30%. “In the derivation study, it did appear that normal PaCO2 and normal Aa gradient, combined with a negative D-dimer, could exclude PE without the need for diagnostic imaging. However, in the validation group this clinical prediction rule did not appear to validate. “Therefore, normal ABG data in combination with negative D- dimer does not allow safe exclu- sion of PE without going on to diagnostic imaging,” Dr. Keays concluded. s Arterial Blood Gas Values Cannot Rule Out PE Astudy of D-dimer in com- bination with a clinical al- gorithm revealed a negative predictive value of 99.5% in patients designated as having a low probability of embolism (Ann. Intern. Med. 2001; 135:98-107). What has become known as the Wells clinical model as- signs probability points to the following seven clinical signs and 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 or more consecutive days or surgery in the previous four weeks (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 embolism on the basis of pretest proba- bility and D-dimer result is safe and decreases the need for diagnostic imaging,” the investigators concluded. Wells Criteria for Pulmonary Embolism Diagnosis ‘Normal ABG data in combination with negative D-dimer does not allow safe exclusion of PE.’ DR. KEAYS ‘LVRS WORKS IN THE REAL WORLD, NOT JUST IN A RANDOMIZED TRIAL, AND IT SETS THE STAGE FOR OUR FINDING THAT LVRS IMPROVED THE BODE INDEX.’
  6. 6. 8 GENERAL THORACIC THORACIC SURGERY NEWS • MARCH/APRIL 2006 B Y S H A R O N W O R C E S T E R Elsevier Global Medical News T he addition of the antioxidant acetyl- cysteine to the standard treatment for 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 randomized to receive standard treatment with pred- nisone and azathioprine plus placebo or the standard treatment plus 600 mg acetylcysteine given three times daily. The absolute difference in the change from baseline among the 71 patients in the acetylcysteine group and the 68 in the placebo group for whom data were ana- lyzed was 0.18 liters (relative difference of 9%) for vital capacity, and 0.75 mmol/min per kilopascal (relative differ- ence of 24%) for single-breath carbon monoxide diffusing capacity (N. Engl. J. Med. 2005;353:2229-41). The number and type of adverse events were similar in the two groups, except those in the acetylcysteine group had a sig- nificantly lower rate of bone marrow tox- icity. Mortality at up to 1 month after treatment completion was also similar at 9% for the acetylcysteine group and 11% for the placebo group, Dr. Maurits Demedts of Katholieke Universiteit Leu- ven (Belgium) and colleagues reported. Although the beneficial effects of acetylcysteine did not translate into a significant survival benefit, the results of this multinational, double-blind study have clinical relevance, according to the investigators. The addition of acetylcysteine—which was previously shown to restore depleted pulmonary glutathione levels and improve lung function in patients with fibrosing alveoli when given at the same high dose used in the present study—is rational in those 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 also noted that the present study “does not permit firm conclusions regarding the effects and side effects of treatment with prednisone plus azathioprine given that there was no placebo group for these drugs.” In an accompanying editorial, Dr. Gary W. Hunninghake, director of the pul- monary, critical care, and occupational medicine division at the University of Iowa, Iowa City, elaborated on this point. He stated that it is plausible that acetyl- cysteine is directly beneficial as a therapy for IPF, but it is also possible that the prednisone and azathioprine combination is 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 is needed to address this issue,” Dr. Hun- ninghake wrote. s 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 OF ADVERSE EVENTS WERE SIMILAR IN THE TWO GROUPS, BUT BONE MARROW TOXICITY WAS LOWER IN THE ACETYLCYSTEINE GROUP. B Y B R U C E K . D I X O N Elsevier Global Meidcal News MO N T R E A L — Endoscopic ul- trasound-guided fine-needle as- piration appears to be more ac- curate than PET with radiolabeled 2-fluoro-deoxy-D- glucose for staging mediastinal lymph nodes in non–small cell lung cancer, according to re- search presented at the annual meeting of the American College of Chest Physicians. Mediastinal lymph node stag- ing determines surgical re- sectability in patients with non–small cell lung cancer (NSCLC), said Dr. Rosemary F. Kelly of the Veterans Affairs Medical Center in Minneapolis. “Ideally, a surgical candidate has a disease process that is limited to the lung or parenchymal lymph nodes only. Parenchymal nodes are considered N1 nodes, and in N0 or N1 disease the role of surgery is clear. N2 disease in- volves metastasis to the ipsilat- eral mediastinal lymph nodes.” Resection here is potentially cur- ative, she noted, especially when there is a positive response to neoadjuvant therapy. Dr. Kelly stressed that “this is the patient population that is critical to accurately identify pre- operatively.” The Minneapolis team con- ducted a prospective, nonran- domized study during May 2003–May 2005 of 65 patients suspected or proven to have NSCLC who were operative can- didates and were not suspected of having metastatic disease. Con- ventional clinical staging was done preoperatively with CT. In addition, FDG-PET scan and en- doscopic ultrasound (EUS) were done on every patient preopera- tively, explained Dr. Kelly. Pathologic staging was done for all patients by medi- astinoscopy and/or nodal dissec- tion at the time of thoracotomy in any patient not already diag- nosed by EUS with malignancy or definitive benign diagnosis. “Patients with a definitive benign diagnosis were still followed for 1 year to confirm the accuracy of the diagnosis,” she said. A PET scan was considered positive when the me- diastinal uptake was distinctly separate from the primary mass. Positive PET usually is defined as having a standard up- take value greater than 2.5. “Any inter- mediate or indeter- minate uptake in the mediastinum was considered negative for this study, Dr. Kel- ly said. To optimize this study, “the nu- clear medicine physi- cian was not blinded to the CT scan results.” In all nodal stations except sta- tion 7, “all identified nodes were biopsied. In the subcarinal area, only nodes [larger than 5 mm], with distinct margins, round or oval, or with a hypoechoic echo- texture were biopsied. [Fine-nee- dle aspiration] passes were done until a diagnosis of malignancy was made, or until the cy- topathologist was convinced of the accuracy of the sample. For benign disease, at least four pass- es were made for each node iden- tified. A staff cytopathologist was present for each procedure and confirmed 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 normal lymph nodes on CT scan (31 pa- tients with clinical stage I dis- ease) and those with enlarged nodes (3 patients with clinical stage IIIA disease). In the stage I group, three of four positive PET scans were shown by EUS to be true malignancy. Of the 27 negative PET scans, 6 turned up pos- itive on EUS. These six patients with unex- pected malignancy were restaged to IIIA. EUS determined the fourth tumor to be be- nign, and there was no evidence of malignan- cy in the mediastinum in 21 patients. The al- gorithm “demonstrat- ed that while EUS was 100% accurate in stage I NSCLC, PET imag- ing had false-positive and [false-] negative results,” said Dr. Kelly. “The most concerning would be the false negatives, where the optimal treatment with neoadju- vant therapy would not be of- fered unless routine medi- astinoscopy was being done. Hopefully, the false-positive PET would have been identified accu- rately by mediastinoscopy if EUS was not available.” In the clinical stage IIIA group, PET identified 16 patients as be- ing negative and 18 patients as having potential disease. EUS–fine-needle aspiration con- firmed 14 of those 18 positives. Of the remaining four, “two had malignancy, but these were in patients [in whom] station 4R nodes were known to be en- larged and positive on PET but inaccessible 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 EUS missed two that were actually malignant. “These two patients had malignancy diagnosed by mediastinoscopy [in which] it was evident that the node was not entirely involved by cancer and was a sampling error of EUS,” Dr. Kelly explained, con- cluding that PET had rather high false negative and false pos- itive rates. In the overall analysis, PET had a sensitivity of 61%, a specificity of 91%, and an accuracy of 77%, compared with 87%, 100%, and 94%, respectively, for EUS. In normal-sized lymph nodes, EUS scored 100% across the board, including positive and negative predictive values. “PET is an interesting modali- ty in that it clearly picks up un- suspected areas of malignancy and can improve the specificity of the CT scan, especially in the mediastinum. However, it then still requires tissue confirmation in PET-positive and PET-nega- tive scans. So you are still stuck using EUS or mediastinoscopy. “The role of PET in directing EUS may be helpful, but we did not blind the endoscopist to the PET and CT results, so we are not able to comment on the role of PET in this situation. Also, PET may be helpful in identify- ing unsuspected extrathoracic metastatic sites, but I have not studied this question,” Dr. Kelly said in an interview. Advantages of EUS include the ability to diagnose tissue as well as the procedure’s low com- plication rate compared with video-assisted thoracic surgery, mediastinoscopy, transthoracic biopsy, and transbronchial biop- sy, Dr. Kelly said. “It is also able to reach nodal areas not within reach of a me- diastinoscope. Finally, EUS is able to biopsy the adrenal glands and the liver when there are questions of metastasis. Overall, EUS is an excellent second step in staging after CT scan because it is able to pursue abnormalities noted on CT and give tissue con- firmation, and it is able to detect metastasis in normal-sized lymph nodes,” she said. The downsides of the proce- dure, she added, are that it re- quires an experienced endo- scopist and an experienced cytopathologist to be present at the time of the procedure to confirm adequate sampling, and it is unable to reach the anterior paratracheal nodes, particularly on the right at the tracheo- bronchial angle. “For this reason, medi- astinoscopy following EUS— where a tissue diagnosis was not possible—may be more thor- ough and complementary to the areas accessible by EUS,” she said. With these limitations in mind, Dr. Kelly strongly recommends EUS over PET, noting that endo- scopists and cytologists often are available at major institutions be- cause the same techniques are be- ing applied to esophageal, gastric, and pancreatic cancers. s Endoscopic Ultrasound Trumps PET in Staging Lymph Nodes ‘While EUS was 100% accurate in stage I NSCLC, PET imaging had false- positive and [false-] negative results.’ DR. KELLY
  7. 7. Focused right on 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 passionate about 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 5 years after surgery, the percentages were 50%, 56%, and 80%, respectively. “There was a significant improvement in physical ability during the preoperative rehabilitation period. There was a further increase in performance after the opera- tion,” he said. “This improvement was maintained for 3 years, followed by a grad- ual decline. Exercise tolerance after 5 years was not worse than preoperative scores.” In the 250 patients at Barnes-Jewish Hospital, the mean follow-up was 5 years with a minimum time interval of 18 months. Follow-up was complete for all patients but one. Patients judged suitable for surgery were enrolled in a 3-month preoperative pulmonary rehabilitation program, said Dr. Cooper, chief of the di- vision of thoracic surgery at the Universi- ty of Pennsylvania, Philadelphia. The postrehabilitation, preoperative data were used as the baseline for com- parisons with postoperative data. After surgery, health-related quality of life, according to the Short Form 36 Phys- ical Functioning Scale scores, showed marked improvement over that reported by the same patients following rehabili- tation but prior to surgery. Of the pa- tients, 96% felt better at 6 months after surgery, and almost 88% felt better at 1 year, he reported. “Thus, experience with LVRS in well-se- lected patients has confirmed that reduc- tion of hyperinflation in patients with end-stage emphysema can provide very significant benefit to the patient. Based upon this principle, several endoscopic approaches to reduce hyperinflation in patients with severe emphysema are being investigated,” 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 fourth leading cause of death. As emphysema- tous destruction of the lung progresses, gas exchange is progressively impaired by the loss of alveolar surface area, which leads to progressive limitation of exercise tolerance and the need for supplemental oxygen administration, said Dr. Cooper. A second consequence of the parenchy- mal destruction is the loss of lung elastic recoil, which leads to progressive hyper- inflation, he said. The crippling effects of emphysema are related 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-stage emphysema includes bronchodilators, an- tibiotics, and inhaled or systemic steroids— all directed at improving expiratory airflow to reduce hyperinflation, improve respira- tory mechanics, increase exercise toler- ance, and reduce dyspnea, Dr. Cooper said. “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 patients with end-stage emphysema, but the pro- cedure is appropriate only when the pat- tern of destruction is heterogeneous, al- lowing essentially nonfunctional, grossly overinflated portions of the lung to be re- moved, said Dr. Cooper. “The benefits of LVRS have been well established 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 for LVRS or that can undergo volume reduc- tion by means of endobronchial valves. Nonetheless, these patients are subject to the same crippling effects of hyperinflation as 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 direct communication is provided between seg- mental bronchi and adjacent lung parenchyma by means of stents placed through the bronchial wall with one end in the airway and the other in the lung parenchyma,” Dr. Cooper said. Because of the extensive collateral ventilation in such patients, several airway bypass stents can deflate an entire lung. The feasibility of ap- plying this procedure to emphysema pa- tients has been demonstrated. “Phase I clinical trials have confirmed the safety and efficacy of this approach in a small series of patients,” he said. s MARCH/APRIL 2006 • THORACIC SURGERY NEWS GENERAL THORACIC 9
  8. 8. 10 CARDIOPULMONARY TRANSPLANT THORACIC SURGERY NEWS • MARCH/APRIL 2006 Operative mortality and intubation rate were similar in the repair and nonrepair groups. Cardiac Repair Doesn’t Raise Transplant Risks B Y D I A N A M A H O N E Y Elsevier Global Medical News OR L A N D O — Cardiac interven- tions performed as a prerequisite to or concurrent with lung transplan- tation do not increase operative morbidity or mortality, compared with lung transplantation in pa- tients who do not need cardiac in- tervention, a retrospective study has shown. The findings suggest that the presence of cardiac disease, if it can be addressed, should not pre- clude lung transplantation, said Dr. Scott B. Johnson at the annual meeting of the Southern Thoracic Surgical Association. “Given the relative scarcity of donor organs, especially for lungs, recipient selection criteria must be continuously reevaluated so that or- gan allocation remains appropriate,” said Dr. Johnson. Toward this end, he and col- leagues at the University of Texas Health Science Center in San An- tonio “began to ask ourselves whether we were doing the right thing by performing lung trans- plantation in patients who also needed cardiac interventions.” The thoracic surgeons reviewed the charts of all the patients who underwent lung transplantation at their institution between the years 1994 and 2004. During the 10-year period, 132 lung transplantations were per- formed in 130 patients. Of the full cohort, 13 of the patients had asso- ciated cardiac procedures. In 6 of the 13 patients, the cardiac inter- ventions were performed in antici- pation of the transplant and in- cluded three angioplasty/stent placements, two coronary artery bypass surgeries, and one mitral valve replacement. The remaining seven patients had concomitant car- diac procedures, including five patent foramen ovale (PFO) clo- sures, one coronary artery bypass surgery, and one ventricular septal defect closure. The primary indication for lung transplantation for the cardiac in- tervention group was fibrotic re- strictive lung disease. For the non- cardiac group, chronic obstructive lung disease was the most common indication for the surgery, said Dr. Johnson. Mean age, gender, and number of postoperative days on the ventilator were similar for both groups. “Of note is the fact that 47% of the non- cardiac group and 46% of the car- diac group were intubated for less than 24 hours,” said Dr. Johnson. And although the median length of hospital stay tended to be longer in the cardiac group, the differences were not statistically significant, he added. There was a statistically signifi- cant increase in the number of bi- lateral transplants performed in the cardiac group, but this difference did not have an impact on outcome, according to Dr. Johnson. “The operative mortality in both groups was similar, with a rate of 7.7% [one death] in the cardiac group and 7.5% [nine deaths] in the noncardiac group,” he said. The pre- dominant cause of death in all pa- tients was primary graft failure and sepsis. The one death in the cardiac group occurred in a patient who had a bilateral transplant with con- current PFO closure. With respect to morbidity, 51 of the 111 survivors in the noncardiac group developed a total of 101 com- plications, for an overall morbidity rate of 46%. By comparison, 7 of the 12 sur- vivors in the cardiac group devel- oped a total of 12 complications, for an overall morbidity rate of 58%— representing a non–statistically sig- nificant increase, according to Dr. Johnson. The most common com- plications in both groups were reperfusion injuries after take-backs to the operating room for any rea- sons, he said. The Kaplan-Meier survival curves for both groups showed no statisti- cally significant differences. Howev- er, “most of our survivors from the cardiac group are not yet out past 3 years from surgery, while some from the cardiac group are much farther out,” noted Dr. Johnson. Nonetheless, he said, “our con- clusion from this investigation is that patients who are otherwise deemed good candidates for lung transplantation but who are found to have associated cardiac abnor- malities should still be considered for transplantation if the cardiac condition can be addressed success- fully before the transplant, or con- comitant with the transplant. Doing so does not appear to increase op- erative mortality or adversely affect long-term survival.” s THE PRESENCE OF CARDIAC DISEASE, IF IT CAN BE ADDRESSED, SHOULD NOT PRECLUDE LUNG TRANSPLANTATION. B Y M A R Y E L L E N S C H N E I D E R Elsevier Global Medical News NE W YO R K — Surgeons at Columbia University in New York are performing laparo- scopic Nissen fundoplication in many lung transplant re- cipients who show evidence of significant gastroe- sophageal reflux and chronic rejection, Dr. Joshua R. Sonett said at a conference on pulmonary and critical care medicine sponsored by Co- lumbia University. The theory behind the surgery is that gastroe- sophageal reflux disease (GERD) contributes to lung injury and the development of bronchiolitis obliterans syn- drome (BOS), an Achilles heel for long-term survival of lung transplant patients. Hence, preventing GERD will im- prove lung function and pre- vent chronic rejection after transplant, 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., found that performing fundoplica- tion in lung transplant recipi- ents with GERD improved lung function (J. Thorac. Car- diovasc. Surg. 2003;125:533- 42). The researchers used an esophageal pH probe to assess reflux, and found abnormal pH values in 93 of 128 patients (73%) who had undergone a lung transplant. Patients who underwent fundoplication had improved bronchiolitis obliter- ans syndrome scores, and some no longer met the crite- ria for BOS. Researchers at the Universi- ty of Toronto obtained similar results, said Dr. Sonett. The improvement in scores exhibited by those who re- ceived fundoplication is key, because for most lung trans- plant recipients who begin to have bronchiolitis obliterans syndrome, there is no turning back, Dr. Sonett said. In addition to contributing to BOS, reflux disease causes bronchospasm and aspiration, and exacerbates asthma, he added. Thus far, there have been virtually no effective thera- pies to stop chronic rejection, he said. “We now know that chron- ic reflux can lead to chronic rejection in the lung,” Dr. Sonett said. “It’s not the whole story, but there’s cer- tainly a population of patients post transplant who have re- flux that go on to chronic re- jection, and if you stop that reflux, they will stop having chronic rejection.” Researchers also have be- gun to consider the role that reflux disease plays in patients with interstitial lung disease and other lung diseases pre- operatively. Clearly, physicians should not perform reflux procedures in patients just because they have GERD and interstitial lung disease, he said, but re- searchers need to continue to look at what subset of patients could benefit from antireflux procedures. s GERD Surgery Can Benefit Lung Transplant Patients Clinical Need, Likely Survival Will Dictate Lung Allocation B Y M A R Y E L L E N S C H N E I D E R Elsevier Global Medical News NE W YO R K — The new need-based lung allocation system that went into effect last May has the potential to reduce the number of deaths of patients on the waiting list for a transplant, Dr. Joshua R. Sonett said at a conference on pulmonary and critical care medicine sponsored by Co- lumbia University. The new system allocates lungs on the basis of clinical need and likely survival after transplant rather than on the sole basis of time spent on the waiting list. The United Net- work for Organ Sharing gives each patient a score from 0 to 100 based on an algorithm that includes the patient’s diagnosis and other factors that affect survival both on the waiting list and post transplant. The new design could help patients in later stages of dis- ease who, under the old sys- tem, might not have survived the 1-3 years on the waiting list, said Dr. Sonett, surgical director of the Columbia University lung transplanta- tion program. The old system also wasted time when a lung became available because physicians had to sort through hundreds of patients who were high on the waiting list but weren’t ready for a transplant. Under the new system, patients move up or down the list on the basis of clinical changes, so they should be given a high score only when they are ready for a transplant, he said. But the system has potential drawbacks, Dr. Sonett said. For starters, the new design is complex and has not been prospectively evaluated. In ad- dition, because patients no longer spend years accruing time on the waiting list, they may be less physically and psy- chologically prepared for their transplant. A lung transplant is com- plex, and patients’ conditioning is critical to their 5- and 10-year survival, Dr. Sonett said. It’s key for physicians to make ear- ly referrals to a transplant team so patients can begin to pre- pare for a transplant, he said. Officials at the Department of Health and Human Ser- vices published a final rule in 1999 that required the United Network for Organ Sharing to amend organ distribution algorithms to direct organs to those most in need—those most at risk of death without a transplant. This was to be balanced with utility to avoid futile transplants. The problem under the old system was that too many pa- tients on the list were dying as they waited for a transplant. But the challenge in revising the system to reflect a need- based approach is that pul- monary diseases are so differ- ent from most other diseases that it’s difficult to figure out which patients are sicker, Dr. Sonett said. s ‘CHRONIC REFLUX CAN LEAD TO CHRONIC REJECTION.’ IF THAT REFLUX CAN BE STOPPED, REJECTION COULD BE STOPPED.
  9. 9. MARCH/APRIL 2006 • THORACIC SURGERY NEWS CONGENITAL HEART 11 B Y B R U C E J A N C I N Elsevier Global Medical News ST O C K H O L M — Pregnancy in women with isolated congenital pulmonary valve stenosis is associ- ated with an extremely high rate of obstetric and fetal complications, Dr. Willem Drenthen reported at the annual congress of the Euro- pean Society of Cardiology. The specific nature of these complications varies depending on whether the congenital heart defect was surgically corrected before pregnancy, said Dr. Drenthen of University Medical Center, Gronin- gen, the Netherlands. Researchers assumed that pregnancy in women with isolated congenital pulmonary valve stenosis is well tolerated, but data from a Dutch national reg- istry indicate otherwise. The registry has thus far documented 81 complet- ed pregnancies in women with this congenital heart defect. Of those, 44 cases involved women whose valvular anomaly was surgically corrected before pregnancy. Women who had not undergone surgery had only a mild pulmonary valve gradient. About 60% of the pregnancies in- volved at least one obstetric and/or neonatal complication. There was a high incidence of pregnancy-in- duced hypertension in women with uncorrected congenital pulmonary valve stenosis, as well as markedly elevated rates of preterm labor and delivery and postpartum hemor- rhage in patients with a corrected heart 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. s Pulmonary Stenosis Ups Obstetric Risks Corrected (n = 44) Uncorrected (n = 37) Mean birth weight 2,883 g 3,346 g Pregnancy duration 38 weeks 40 weeks Complications Pregnancy-induced hypertension 5 (11%) 11 (30%) Infection requiring antibiotics 8 (18%) 6 (16%) Premature rupture of membranes 5 (11%) 0 Preterm 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 PFO Closure for Migraines B Y D A M I A N M C N A M A R A Elsevier Global Medical News SC O T T S DA L E , AR I Z . — A subset of migraine pa- tients may benefit from clo- sure of their patent foramen ovale, Dr. David W. Dodick said at a symposium spon- sored by the American Headache Society. “We have a responsibility to know the data and give pa- tients proper and appropriate advice,” said Dr. Dodick, pro- fessor of neurology at Mayo Clinic Arizona. Some research indicates an association between a PFO and migraines with aura, particularly in patients with a large left-to-right shunt. In one study, patients with migraine with aura were three times more like- ly to have a PFO than those who experienced migraines without aura. A left-to-right shunt is also more common among mi- graine-with-aura patients. In the Migraine Interven- tion with STARFlex Tech- nology (MIST) study, patients with migraine with aura are assessed by a cardiologist then randomized to closure or no closure. In preliminary results, enrollment data show 60% of 370 participants hav- ing a right-to-left shunt (ver- sus 27% of the general pop- ulation) and 38% having a large PFO (versus 7% of the general population). Studies suggest that clo- sure eliminates migraines in about one-third of mi- graineurs, reduces frequen- cy in another third, and does not alter attacks in an- other third of patients. Many headache specialists still take a conservative stance. There is a reported periinterventional adverse- event rate of about 6%. s
  10. 10. N E W S F R O M T H E A S S O C I A T I O N 12 THORACIC SURGERY NEWS • MARCH/APRIL 2006 Registration and Housing is now open and can be accessed online at www.aats.org until March 24, 2006. The Preliminary Program for the 86th Annual Meeting of the American Asso- ciation for Thoracic Surgery is now available 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 meeting on Saturday afternoon and features dis- cussions on the future of academic practice and training programs and dealing with conflicts of interest. Sunday will feature three concurrent Postgraduate Course Symposia pre- sented by Dr. Stephen J. Mentzer as Chairman of General Thoracic Surgery Symposium, Dr. Gus. J. Vlahakes as Chairman of Adult Cardiac Surgery Symposium, and Dr. Erle. H. Austin III as Chairman of Congenital Heart Disease Symposium. On Wednesday, Dr. Philip Corcoran, chief of cardiothoracic surgery at Wal- ter Reed Army Medical Center, will or- ganize the Global Thoracic Surgery Session entitled International Disaster Relief and Bioterrorism Crisis Response. Dr Corcoran has put together a session that will feature information regarding how we as physicians might be called upon to respond to a bioterrorism threat. In addition, several speakers will talk about the emergency medical responses that were organized for train bombings in London and Madrid as well as the U.S. Gulf Coast hurricane. Concluding this year’s annual meeting are the popular Wednesday morning Controversies in Cardiothoracic Surgery, including a debate on whether the decline in cardiothoracic surgery applications is good for the specialty. Other discussions include: • Thoracic Aortic Stent Grafts Should Only Be Performed by CT Surgeons. • 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 Valve After Multiple Reconstructions of the RVOT Tract. Invited Speakers President, Dr. Richard A. Jonas, has announced his invited speakers for the 2006 annual meeting. This year’s basic science lecturer will be Dr. Robert Horvitz of MIT. Dr. Horvitz is a 2002 Nobel Laureate in physiology/medi- cine, which was awarded for his role in discovering and characterizing the genes involved in apoptosis and pro- grammed cell death. Apoptotic cell death is of great importance in both myocardial and cerebral ischemic in- jury and is of great relevance to all car- diothoracic surgeons.The honored guest lecturer will be Dr. John Howe, who is the President of Project Hope, a major philanthropic organization committed to medical education ef- forts throughout the world. Project Hope helped form the backbone of U.S. medical relief efforts for several natural disasters including the Indone- sian tsunami as well as Hurricane Kat- rina in New Orleans. This year’s Attendee Reception on Tuesday evening will be held at the Franklin Institute. Come and experi- ence hands-on exhibits and explore science in disciplines ranging from sports to space, including the Sports Challenge, which uses virtual reality technology to illustrate the physics of sports; the Train Factory’s climb- aboard steam engine; the Space Com- mand’s simulated earth-orbit research station; a fully equipped weather sta- tion; and exhibits on electricity. Additionally, spouses and guests may participate in a selection of tours, in- cluding the Historic Philadelphia Walk- ing Tour; the Longwood Gardens Tour; and a Day in the Country: East Bank/West Bank. New this year will be a Financial Planning Seminar and Fit- ness Forum. s You must register for these activities. Please visit our website at www.aats.org. Annual Meeting News and Events April 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 to train in new technologies and minimally invasive techniques. The TSRA, together with the Thoracic Surgery Directors As- sociation (TSDA), and in collab- oration with the CTSnet.org Residents Section, has developed the Cardiothoracic Technology Symposium. The Cardiotho- racic Technology Symposium will expose residents to new technologies and techniques in cardiothoracic surgery, will dis- cuss the status and changes in thoracic surgery training, and will enable residents to pursue further training in areas of inter- est. The strong alliance between thoracic surgery residents, pro- gram directors, and the CTS- net.org Residents Section will create an educationally sound, diverse curriculum highlighting novel 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 animal laboratory experience, and an educational session with leaders in thoracic surgery education. Didactic components will fea- ture speakers who are acknowl- edged experts in their fields. Unique to the Symposium will be an opportunity to perform new surgical techniques and use new technologies and products in a cadaver/animal lab setting. The opportunity to perform dif- ferent techniques, exposures, and use new technologies under the tutelage of faculty experts separates the Cardiothoracic Technology Symposium from other resident courses. In addi- tion, there will be an educational session designed to promote dis- cussion between thoracic resi- dents and leaders in thoracic surgery education about evolv- ing changes and the future of thoracic surgery education. This session is designed to provide di- rect information from the lead- ership of the major thoracic surgery educational organiza- tions (American Board of Tho- racic Surgery/Thoracic Surgery Directors Association) to resi- dents regarding proposed and ongoing changes in training pro- grams and manpower issues. The emerging need for surgical diversification and how to train in emerging fields will also be addressed. The Cardiothoracic Technolo- gy Symposium is offered free to all thoracic surgery residents. Residents are encouraged to reg- ister at www.CTSymposium.org, as registration is limited to the first 80 residents on a first-come first-serve basis. All residents must be supported by a letter from their program director. Registration, lodging, and travel costs will be paid by the TSRA/TSDA through the sup- port of industry sponsors. s Cardiothoracic Technology Symposium for Residents CME Activities Now Available Using JTCVS Future AATS Meeting Dates and Locations April 29–May 3, 2006 Pennsylvania Convention Center Philadelphia, PA May 5-9, 2007 Washington DC Convention Center Washington, DC May 10-14, 2008 San Diego Convention Center San Diego, CA May 9-13, 2009 Hynes Convention Center Boston, MA May 1-5, 2010 Metro Toronto Convention Centre Toronto, Ontario More information can be accessed at www.aats.org Keep up with the newest 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 CME activity 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-designated article; take the CME ac- tivity test and evaluation quiz; print your own cer- tificate. s Archived issues of the Thoracic Surgery News are available online at www.aats.org.
  11. 11. October 20 - 22, 2006 InterContinental Hotel and MBNA Conference Center Cleveland, Ohio The Cleveland Clinic Kaufman Center for Heart Failure and The American Association for Thoracic Surgery present www.clevelandclinicmeded.com/heartfailure06 or www.aats.org Synchronizing SURGICAL and MEDICAL Therapies for Better Outcomes 21st CENTURYTREATMENT of HEART FAILURE: 14 THORACIC SURGERY NEWS • MARCH/APRIL 2006 N E W S F R O M T H E A S S O C I AT I O N 2005-2006 Officers and Councilors President Richard A Jonas, M.D. Washington, DC President-Elect Bruce W Lytle, M.D. Cleveland, Ohio Vice President D. Craig Miller, M.D. Stanford, California Secretary Irving L Kron, M.D. Charlottesville, Virginia Treasurer Alec Patterson, M.D. St. Louis, Missouri Editor Andrew S Wechsler, M.D. Philadelphia, Pennsylvania Councilors Tirone E David, M.D. Toronto, Ontario Charles D Fraser, Jr, M.D. Houston, Texas Hartzell V Schaff, M.D. Rochester, Minnesota Craig R Smith, M.D. New York, New York David J Sugarbaker, M.D. Boston, Massachusetts Marko I Turina, M.D. Zurich, Switzerland New NIH Policy On Multiple PI Grant Submissions All Federal research agencies are preparing to implement poli- cies and procedures to formally al- low more than one Principal Inves- tigator (PI) on individual research awards. This presents a new and important opportunity for investi- gators seeking support for projects or activities that clearly require “team science.” The multiple-PI option is targeted specifically to projects that do not fit the single- PI model, and thus is intended to supplement, not replace, the tradi- tional single PI model. The goal is to maximize the potential of team science efforts, responsive to the challenges and opportunities of the 21st century. To view the back- ground information and features of the multiple-PI policy as well as the major issues to be considered in its implementation, go to http://grants2.nih.gov/grants/ multi_pi.
  12. 12. B Y B R U C E J A N C I N Elsevier Global Medical News DA L L A S — The use of NSAIDs— whether cyclooxygenase-2–selective or not—in patients who’ve had an acute MI increases their risk of mortality, especial- ly in higher doses, according to data from the Danish National Patient Registry. To patients with ischemic heart disease, “I would say that you should try to avoid these drugs, but if you need to take them, use lower doses,” Dr. Gunnar H. Gislason said at the annual scientific sessions of the American Heart Association. The widely publicized prior studies that revealed the increased risks of MI and death associated with NSAID use—and that resulted in some COX-2-selective agents being taken off the market as well as an across-the- board black box la- bel warning for all NSAIDs—were based largely on pa- tient populations with an average background cardio- vascular risk. Dr. Gislason and his coinvestigators sought to learn whether the in- creased cardiovas- cular risk associated with NSAID use also applied to pa- tients at very high cardiovascular risk: namely, those who’ve already had an MI. Funding for their study was provided by the Danish Heart Foundation. Dr. Gislason reported on all 58,432 pa- tients discharged from Danish hospitals following a first acute MI during 1995- 2002. A centralized national prescription database revealed that more than 40% of these first-MI survivors subsequently filled at least one prescription for an NSAID. Nearly 10% of all patients used a COX-2 inhibitor 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- edwithafour-tofivefoldincreasedmortality riskduringthetimeapatientwasonthedrug, compared with NSAID nonusers. Lower- dose therapy with a COX-2 inhibitor was as- sociatedwithalesser—albeitsignificantlyin- creased—mortality risk. (See box.) The risk calculations were adjusted for comorbid ill- nesses, age, gender, and socioeconomic sta- tus, according to Dr. Gislason of Bispebjerg UniversityHospital,Copenhagen.High-dose therapy with nonselective NSAIDs was also associated with increased mortality risk. The rate of out-of-hospital deaths was unusually high in the NSAID users, and the causes are being examined using death certificate data. One possibility is that NSAID users had an excess of arrhythmic deaths outside the hospital. In addition, hospitalization for heart failure after an MI was more common among users of COX- 2 inhibitors. s MARCH/APRIL 2006 • THORACIC SURGERY NEWS ADULT CARDIAC 15 INDEX OF ADVERTISERS ATS Medical Corporate 9 Bayer Pharmaceuticals Corporation Corporate 20 Cook Incorporated AAA 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 Elsevier Global Medical News DA L L A S — Infusion of bone-mar- row progenitor cells into a coronary artery after a myocardial infarction led to significantly improved left ven- tricular function in a controlled study with almost 200 patients. “This is the first large, proof-of- concept trial to clearly show the benefit of progenitor cells in post–myocardial infarction pa- tients,” Dr. Volker Schächinger said at the annual scientific sessions of the American Heart Association. “Large-scale clinical–end point tri- als are now needed to assess the ef- fect of intracoronary infusion of bone-marrow cells on morbidity and mortality in patients,” said Dr. Schächinger, professor of medicine at J.W. Goethe University in Frankfurt. “The data give compelling evi- dence of the treatment’s benefit,” but the new findings conflict with a prior report from Belgian researchers that failed to show increased ven- tricular function following similar treatment, commented Dr. Philippe Menasche, a cardiovascular surgeon at the Georges Pompidou European Hospital in Paris. Because of these conflicting findings, “additional, large-scale trials are warranted to clarify the efficacy issue,” he said. The study enrolled 204 patients who had an ST-segment elevation MI and who were successfully reper- fused with either a percutaneous coronary intervention or a throm- bolytic drug. The study was done at 16 medical centers in Germany and 1 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 ficoll gradient to enrich for progenitor cells, which takes about 90 minutes. Patients then received an infusion into their infarct-related artery of ei- ther the progenitor cells in growth medium, or the medium with no cells, as a control. An average of 236 million cells were infused into each patient who received bone-marrow cells. They were introduced with a stop-flow catheter that briefly halted blood flow within the treated artery. Left ventricular ejection fraction (LVEF) was measured at the time of treatment and 4 months later, using left-ventricular angiography. During follow-up, LVEF increased by an average of 3.0% over baseline in 92 evaluable control patients and by an average of 5.5% in 95 evalu- able patients who received bone marrow cells, a statistically signifi- cant effect for the study’s primary end point, Dr. Schächinger said. Two additional analyses were done to identify conditions that were linked to the best outcomes. One divided the patients into the 93 evaluable patients who had an LVEF of less than 49% at baseline and the 94 evaluable patients with LVEF of 49% or greater at baseline. In the patients with LVEF of less than 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 control patients, a statistically significant dif- ference. In patients who had LVEF of 49% 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 they were treated after their MI. Patients who received cell treatment 5 or more days after their infarction had an average 7.0% increase in LVEF, compared with an average 1.9% in- crease among control patients, a sig- nificant difference. Patients treated less than 5 days after their infarction did not have a significant improve- ment, compared with the controls. The researchers aren’t sure why patients responded better if treat- ment was delayed a few days. “Ear- ly after a myocardial infarction, the myocardium is a hostile environ- ment, with inflammation and ox- idative stress. That may be why it’s better to delay treatment,” Dr. Schächinger said. “We can’t draw conclusions regarding the mecha- nism ... [but] we clearly showed a benefit that’s better than placebo.” The Frankfurt researchers plan to do a study with about 1,200 patients that will focus on treating patients with an LVEF of less than 50%, and with marrow-cell treatment delayed until at least 6 days after an MI, Dr. Andreas M. Zeiher, professor and chief of cardiology at Goethe Uni- versity and senior investigator for the study, said in an interview. s Bone-Marrow Cells Boost Left Ventricular Function After MI CVD, Erectile Dysfunction Link B Y R O B I N S E AT O N J E F F E R S O N Elsevier Global Medical News Erectile dysfunction should be considered a red flag that a man is at in- creased risk for cardiovas- cular events and deserves evaluation, according to Dr. Ian M. Thompson of the University of Texas, San An- tonio, and his associates. They prospectively as- sessed a cohort of 9,457 men for both of these dis- eases over the course of 7 years (JAMA 2005;294:2996- 3002). The men in this study were the subset of participants enrolled in the Prostate Cancer Prevention Trial who were randomized to placebo. As part of that study, they were evaluated every 3 months for cardio- vascular disease and erectile dysfunction. 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 at study entry. Of the 4,247 men without erectile dys- function at study entry, 2,420 (57%) reported inci- dent erectile dysfunction after 5 years. Risk factors of CVD and erectile dysfunction are similar, judging from find- ings from proportional hazards regression models. Incident erectile dys- function signaled an in- creased risk for subsequent cardiovascular events (haz- ard ratio of 1.25). For men with either incident or prevalent erectile dysfunc- tion, the risk was greater (hazard ratio 1.45). For sub- sequent cardiovascular events, the unadjusted risk of an incident cardiovascu- lar event was 0.015 per per- son-year in men without erectile dysfunction at study entry and was 0.024 per person-year for men with erectile dysfunction at study entry. This associ- ation was in the range of risk associated with current smoking or a family histo- ry of myocardial infarction, the authors reported. An increasing number of men aged 40-69 years have been seeking care for erec- tile dysfunction since the advent of effective drug therapy. That office visit gives physicians an oppor- tunity to screen such men for standard cardiovascular risk factors, “and, as ap- propriate, initiate cardio- protective interventions,” Dr. Thompson wrote. s

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