1 VOL. 3 NO. 5 SEPTEMBER/OCTOBER 2007 THE OFFICIAL NEWSPAPER OF THE AMERICAN ASSOCIATION FOR THORACIC SURGERY Diagram of glycosylated hemoglobin superimposed on micrograph of red blood cells: Bold shows the two sugar moeities in place. Serum Hemoglobin A 1c Predicts CABG Results BY MITCHEL L. ZOLER WASHINGTON Serum level of hemoglobin A 1c was better than diabetic status for identifying patients with the highest risk of bad outcomes following coronary artery bypass surgery, in a review of more than 3,000 patients. A hemoglobin A 1c [HbA 1c ] level of 7% or higher was a powerful predictor of in-hospital mortality or morbidity after elective coronary artery bypass surgery, Dr. Michael E. Halkos said at the annual meeting of the American Association for Thoracic Surgery. In contrast, patients with an HbA 1c level lower than 7% had mortality and morbidity that were similar to those of patients without diabetes, said Dr. Halkos, of the division of cardiothoracic surgery at Emory University, Atlanta. These findings raise the possibility of delaying elective coronary surgery in patients with poorly controlled diabetes until their control improves and their serum level of HbA 1c drops, he said. In addition, future studies should examine a possible prognostic role for HbA 1c in patients undergoing other types of elective cardiac surgery. The review included 3,555 consecutive patients who underwent primary, elective coronary artery bypass graft (CABG) at the university during April 2002 June The series included 3,089 patients whose records included a Thoracic Surgery Fellowship 2008 Matches 9% Unmatched 91% Matched Applicants (n = 96) Source: National Resident Matching Program See Serum HbA 1c page 12 V I T A L S I G N S 33% Unfilled Positions (n = 130) 67% Filled DIAGRAM: ELSEVIER, INC. BIOPHYSICAL CHEMISTRY 72 (1998) , BACKGROUND: DR. DAVID M. PHILLIPS/GETTY IMAGES ELSEVIER GLOBAL MEDICAL NEWS Survival Similar for Two Mesothelioma Resection Options EPP, P/D similar, not interchangeable. BY MITCHEL L. ZOLER WASHINGTON The two surgical options typically used for resecting malignant, pleural mesothelioma produced similar outcomes in a series of 663 consecutive patients from three centers. But despite similar median survival rates following both extrapleural pneumonectomy (EPP) and pleurectomy/decortication (P/D), these two procedures are not interchangeable, Dr. Raja M. Flores said at the annual meeting of the American Association for Thoracic Surgery. That s because the primary goal of surgery is to achieve at minimum an R1 resection of the tumor, defined as removal of all gross disease, which leaves behind only microscopic traces of the cancer, said Dr. Flores, a thoracic surgeon at Memorial Sloan-Kettering Cancer Center in New York. The ultimate goal is to produce an R0 BY MITCHEL L. ZOLER WASHINGTON Patients who are age 65 or older can successfully undergo lung transplantation, based on an experience with 48 patients treated at a single center. Our results suggest that a select group of older patients can safely undergo lung transplant with acceptable outcomes, Dr. Sam Bastani said at the annual meeting of the American Association for Thoracic Surgery. The older patients generally lacked other comorbidities, they usually received a single lung, and they often received a lung from a nonstandard donor, said Dr. Bastani, a surgeon at the University of California, Los Angeles. Although consensus guidelines specify an upper age limit resection, which means that all microscopic and gross disease has been removed, but this is often not possible. The resection result to be avoided is that of leaving gross tumor behind, an R2 resection. An EPP is an en-bloc resection of the lungs, pleura, pericardium, and diaphragm. The P/D spares the entire lung; it removes the parietal and visceral pleura, and removes the pericardium and diaphragm only when necessary. Thus, it is a more sparing procedure. Most patients with stage 1 mesothelioma are treated with the more sparing P/D. These patients have less bulky tumors, and few need an EPP. But, in fact, even in some patients with a stage 3 tumor, an R1 resection can be achieved with a P/D. Frequently, however, the more extensive EPP resection is needed to achieve an R1 result. If a patient has a big, bulky tumor, you need to use EPP. Pe- See Resection page 4 Lung Transplants Succeed in the Elderly of 65 for patients receiving a single lung and 60 for patients getting a bilateral lung transplant, surgeons at UCLA stopped using age as an absolute contraindication in They reviewed their experience during March 2000 September 2006, during which 48 patients age 65 or older received lungs. The characteristics and outcomes of these patients were compared with a group of patients younger than 65 who re- THORACIC SURGERY NEWS 60 Columbia Rd., Bldg. B Morristown, NJ CHANGE SERVICE REQUESTED I N S I D E News Robotic Future? Will operating rooms of the future be devoid of anyone but the patient? 2 General Thoracic Wake Up! ICU protocol awakens patients from sedation and tests unassisted breathing. 6 Adult Cardiac Hearts Aflutter Postop atrial fibrillation may be more of a mortality risk than expected after CABG. 12 Avoiding Endocarditis American Heart Association guidelines updated on preventing infection. 13 ceived one or two transplanted lungs at UCLA during the same period. The younger patients were selected for analysis by matching them with the older patients based on diagnosis, transplant date, and lung allocation score. A series of relative contraindications were applied to the older patients that could ex- See Elderly page 14 Presorted Standard U.S. Postage PAID Permit No. 384 Lebanon Jct. KY
2 2 NEWS T HORACIC S URGERY N EWS SEPTEMBER/OCTOBER 2007 BY BETSY BATES L AS V EGAS Surgery in the future will look a lot like surgery today that is, if you operate at a cockpitlike console, conduct rounds by robot, use smart scalpels that sense when you re close to a blood vessel, and conduct dress rehearsals of complex operations using virtual body images of your patients anatomies. Star Trek, anyone? Dr. Richard M. Satava asked an audience at the spring meeting of the American College of Surgeons. It s almost here, explained Dr. Satava, professor of surgery at the University of Washington, Seattle, and Dr. C. Suzanne Cutter, of New York Hospital Queens, Flushing, N.Y., in two separate futuristic sessions at the meeting. Dr. Satava opened his presentation with an animated video depicting a robotically controlled, armored casualty evacuation vehicle scooping up an injured soldier from a battlefield, scanning him for injuries, automatically starting an IV, and prepping him for surgery that is performed by a surgeon watching the scene from a remote, safe location. For the most part, lasers and other energy sources are used in the operation, but when a new tool is needed, a robotic scrub nurse replaces the one in the robotic arm controlled by the surgeon from his console. When the procedure is finished, the soldier is evacuated to safety on an unmanned air vehicle. The system is based on a new paradigm of A Futuristic New World of Surgery Envisioned Robotic scrub nurses, smart scalpels, and mobile operating rooms without people are on the horizon. bringing the operating room to the wounded soldier, not the soldier to the operating room, with the ultimate aim of reducing the golden hour to the golden minute. Such a scenario may seem far-fetched and years away, but there was nothing in the video that has not already been physically built, Dr. Satava noted. He expects to see a transition from tissues and instruments to information and energy. Virtual whole-body images, novel energy sources, and traditional surgical tools will be integrated into information systems controlled by the surgeon from a console. A robot is not a machine; it is an information system with arms, he said. A CT scanner is not an imaging device; it is an information system with eyes. Lifelike surgical rehearsals will be conducted, allowing surgeons to peer into organs and vessels as they navigate their way through superimposed real-time and Computer-assisted design/computer-assisted manufacturing model shows an operating room where no on-site humans, other than the patient, are required. stored body images, where mistakes can be made on patients images rather than the patients themselves. High-intensity focused ultrasound will be coupled with portable ultrasound during surgery, which means that diagnosis and treatment of traumatic bleeding can be accomplished with the same instrument. Robotic scrub nurses will work from robotic tool-changer carousels capable of dispensing 210 supplies in an average of 7 seconds per instrument. Currently, it takes 17 seconds for a nurse to change a tool on the da Vinci robotic system. Each time an instrument or supply is used, the patient will be billed, the item restocked, and a new one ordered, all in the span of about 50 milliseconds, said Dr. Satava. Stem cell based tissue engineering will also radically transform surgery, he predicted. I know 23 operations on the stomach, depending upon if you have cancer or an ulcer or bleeding. In the future, with tissue engineering and artificially grown organs, how many operations do you think I m going to do on the stomach? One. No matter what s wrong with the stomach, I will take out your stomach and give you a brand new one, he declared. Since immunosuppression will be irrelevant if patients receive stem cell derived organs constructed according to their anatomy, Dr. Satava questioned whether transplant specialists will become obsolescent. But he said the future looks promising for cell surgery specialists, who may one day conduct microscopic biosurgery, removing individual genes and replacing them with healthy substitutes. Dr. Cutter painted a picture of the future for today s young surgeons, who are riding a tidal wave, almost a tsunami of change. Residents will undergo simulation training using the virtual bone setter, the minimally invasive surgery trainer, and the virtual autopsy. Bloodless surgery will give way to scarless natural orifice transluminal endoscopic surgery (NOTES). Patients will lie in suspended animation rather than being anesthetized, and operating rooms will have active ceilings, featuring hundreds of lights interspersed with cameras and threedimensional operating views, she said. Doing rounds by robot will save time for surgeons and other physicians. Their images will be projected on a screen at the patient s bedside, ironically allowing more face-to-face communication than many patients now experience with their surgeons. We re entering the age of biointelligence, Dr. Cutter said. A prototype of an operating room without people was built from the CAD/CAM model at left. PHOTOS COURTESY PABLO GARCIA/SRI INTERNATIONAL AMERICAN ASSOCIATION FOR THORACIC SURGERY Editor Edward D. Verrier, M.D. Associate Editor, General Thoracic Yolonda L. Colson, M.D., Ph.D. Associate Editor, Adult Cardiac Aubery C. Galloway, M.D. Associate Editor, Cardiopulmonary Transplant Robin Pierson, 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 International Medical News Group and. 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 Society News Group, a division of 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. THORACIC SURGERY NEWS POSTMASTER: Send changes of address (with old mailing label) to Circulation, THORACIC SURGERY NEWS, 60 B Columbia Rd., 2nd flr., Morristown, NJ The American Association for Thoracic Surgery headquarters is located at 900 Cummings Center, Suite 221-U, Beverly, MA THORACIC SURGERY NEWS (ISSN ) is published bimonthly for the American Association for Thoracic Surgery by Elsevier Inc., 60 B Columbia Rd., 2nd flr., Morristown, NJ 07960, , fax National Account Manager Stephen H. Close, , fax , Classified Sales Manager Jaesam Hong, , fax , Address Changes Fax change of address (with old mailing label) to or change to Advertising Offices 60 B Columbia Rd., 2nd flr., Morristown, NJ 07960, , fax Classified Advertising Offices 360 Park Ave. South, 9th Floor, New York, NY 10010, ELSEVIER SOCIETY NEWS GROUP, A DIVISION OF INTERNATIONAL MEDICAL 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 VP, Medical Education Sylvia H. Reitman Senior Director, Marketing and Research Janice Theobald Circulation Analyst Barbara Cavallaro Executive Director, Operations Jim Chicca Director, Production and Manufacturing Yvonne Evans Production Manager Judi Sheffer Art Director Louise A. Koenig EDITORIAL OFFICES 5635 Fishers Lane, Suite 6000, Rockville, MD 20852, , fax Letters to the Editor: Copyright 2007, by the American Association for Thoracic Surgery
3 SEPTEMBER/OCTOBER 2007 T HORACIC S URGERY N EWS NEWS 3 Global Report on Pediatric Cardiac Health Released BY MARK S. LESNEY D iagnosing and treating congenital heart disease outside of developed countries remain major problems for pediatric health across the world, despite some recent improvements in strategies and infrastructure in selected nations. The disparity is tremendous, with approximately one facility capable of performing open heart surgery for every 120,000 people in the United States, compared with one similarly capable center for every 33 million people in Africa, or every 16 million people in Asia. This means that the majority [of children with congenital and acquired heart diseases] will never receive the treatment they need, according to Children s HeartLink, an international medical charity founded in Minneapolis in They have produced a report entitled Linked by a Common Purpose: Global Efforts for Improving Pediatric Heart Health. The entire report is online at It is the second report prepared by Children s HeartLink, BY MARK S. LESNEY ABTS Changes Certification Paths and Case Requirements The American Board of Thoracic Surgery has revised standards for individuals to qualify for entrance into its certification process, effective for all thoracic surgery residents as of July 1, 2007, according to its Web site (www.abts.org). The board lists two primary pathways to certification, a cardiothoracic surgery pathway and a general thoracic surgery pathway, with an additional special certificate pathway for candidates who complete the cardiothoracic surgery track and plan to perform congenital heart surgery. In consultation with other thoracic surgery organizations including the [Residency Review Committee for Thoracic Surgery], the Joint Council for Thoracic Surgery Education and the [Thoracic Surgery Directors Association], the Board has established new operative case criteria, with revised case requirements for both primary tracks and added qualifications for congenital heart surgery, the ABTS stated. Both the general thoracic surgery (GTS) pathway and the cardiothoracic surgery (CTS) pathway require participation in 255 total cases, but participation level and type of operation differs according to the pathway chosen. For example, the CTS pathway retains the previous requirement of 20 congenital heart cases (10 as primary and 10 as first assistant) whereas the GTS pathway now requires only 10 congenital heart cases (as first assistant). Similarly, the CTS pathway retains the previous requirements of 50 lung, pleura, chest wall cases (30 pneumonectomy, lobectomy, segmentectomy; 20 other), whereas the GTS pathway raises the requirements to 100 cases (with a distribution). The new Congenital Heart Surgery Certification of Added Qualifications requires a minimum fellowship lasting 12 consecutive months in a program whose director must be a congenital heart surgeon. The fellowship is intended to follow satisfactory completion of thoracic surgery training in an Accreditation Council for Graduate Medical Education approved program. The operative experience must include a minimum of 75 major congenital cases and must include the following index cases: VSD (5), AVSD (4), TOF (4), arch reconstruction including coarctation (4), arterial switch (4), and Glenn/Fontan (5). The proposal to create the special certification of added qualifications was unanimously approved by the ABTS board of directors in 2005, according to Dr. Edward I. Bove of the University of Michigan, Ann Arbor, in his presentation on the future of congenital heart surgery education at the American Association for Thoracic Surgery annual meeting earlier this year. The proposal was prompted by the recognition that the discipline of congenital heart surgery requires unique skills and education that are not currently provided in a standard thoracic surgery residency. Furthermore, current postresidency congenital cardiac surgery fellowships lack uniformity and quality control, said Dr. Bove, one of the directors of the ABTS. These new pathway and certification requirements have been initiated in an era that may signal the start of cardiothoracic surgery shortages. Such concerns have been raised for the past several years by both the American Association for Thoracic Surgery and the Society of Thoracic Surgeons, who jointly conducted a recent workforce study with the American Association of Medical Colleges (AAMC). The AATS hosted a June summit meeting in Chicago to address the CT surgery shortage, as well as residency training and curriculum issues, and the STS hosted a press and congressional briefing, A Shortage of Heart and Lung Surgeons: A Crisis in Care, on June 20 at the U.S. Capitol. The combination of a declining number of fellowship positions filled, an aging population of patients, and an aging population of cardiothoracic surgeons (average age of 55) which will lead to increased retirements in the near future highlights the problem, according to the AATS/STS/AAMC Workforce Study. For example, after the June 13, 2007, Match Day, 33% of the 130 certified thoracic surgery fellowships remained unfilled. This is similar to last year s situation when a third of positions also remained unfilled. This year, there were only 96 certified applicants for open positions and of these 9% (9 applicants) were unmatched. whose goal is to help improve existing cardiac programs in underdeveloped countries so that they are more empowered to care for children in their own regions with consistent, quality and sustainable services. The report details the incidence and prevalence of congenital and acquired heart disease. Although congenital heart problems occur at similar rates in both the developed and developing world, diagnosis and treatment are often delayed in the poorer countries, which creates a significant backlog of cases for treatment centers, even when treatment is available. In addition, acquired heart problems such as rheumatic heart disease, which has been almost eliminated in the developed world remain a significant problem for many developing countries. The report also highlights trends and issues in the attraction and retention of nurses and physicians into the pediatric heart health arena in places they are most needed. An important feature of the report is a response survey of cardiac surgeons (more than half of respondents), cardiologists, and others working in the field of pediatric care from over 90 countries that was conducted in September/October Although 18% of respondents were from the United States, 72 % were from individuals working in cardiac services in the developing world. A total of 322 responses (12.5% of surveys sent) were returned. Key results of the survey include the fact that the greatest frustrations or challenges the respondents face when working to treat children with heart disease in the developing countries are lack of supplies, facilities, and/or personnel (46%); prohibitive costs (26%); lack of institutional support (14%); and late referrals and/or inadequate pre- and postoperative care (14%). When asked what the international community could do to help treat and prevent pediatric heart disease in the developing world, respondents cited better education and training (31%); better funding and resources (31%); better coordination of efforts (23%); and better institutional support (15%). Children s HeartLink works primarily with hospitals in China, Costa Rica, Ecuador, India, Kenya, Malaysia, Ukraine, and South Africa, providing surgery, education, training, technical assistance, rheumatic fever prevention programs, and donated equipment and supplies. Esophageal Ca Radiotherapy May Cause Perfusion Defects BY JEFF EVANS WASHINGTON Newer radiation therapy methods for treating esophageal cancer may be inducing myocardial perfusion defects that can kill patients before the cancer does, Dr. Isis Gayed reported at the annual meeting of the Society of Nuclear Medicine. Although older radiation therapy (RT) techniques for esophageal cancer are known to induce heart disease and coronary artery disease, it is unknown whether 3-D conformal, intensity-modulated, or proton techniques spare the heart or also carry a risk of radiation-induced myocardial perfusion defects. In a review of 13 esophageal cancer patients, Dr. Gayed and her colleagues found that cardiac complications developed in 5 patients after RT. Two of those five died as a result of myocardial perfusion abnormalities, not from cancer. Previous studies have suggested that myocardial perfusion abnormalities that developed in esophageal cancer patients who underwent RT are inconsequential because the patient will die of cancer before dying or suffering from heart disease, said Dr. Gayed of the department of nuclear medicine at the University of Texas M.D. Anderson Cancer Center, Houston. She and her associates previously published a review that found a significantly higher rate of myocardial perfusion defects in esophageal cancer patients who received RT, compared with those who did not (54% vs. 16%, respectively) ( J. Nucl. Med. 2006;47: ). In the current study, all 13 patients had normal myocardial perfusion studies at baseline, except for 1 patient with a fixed septal defect and a left bundle branch block. The radiation techniques included 3-D conformal RT in six patients, intensitymodulated RT in six patients, and one with an unspecified RT type. Three patients developed new inferior wall ischemia on myocardial perfusion imaging (MPI) after treatment with 3-D conformal RT. Two of these three patients later died: one from bradycardia and an atrioventricular block and another from nonmalignant pericardial and pleural effusion. The other patient with inferior wall ischemia complained of chest pain upon returning to work. The mean radiation dose to the heart was quite high at 33.6 Gy and involved a mean heart volume of 750 cc, Dr. Gayed said. The area of myocardial perfusion abnormalities on MPI studies was closely correlated with the area of the heart covered by the radiation field, she said. The investigators believe that the abnormalities may cause both left main coronary artery and microvascular disease, based on autopsy studies and other articles in the literature. One patient had no MPI abnormalities but developed new-onset atrial fibrillation after 3-D conformal RT. Another patient had a recurrence of atrial fibrillation and congestive heart failure after intensitymodulated RT. Another three patients died of noncardiac causes. Dr. Gayed and her colleagues recommended conducting larger studies to confirm the risk mainly seen with 3-D conformal RT. They advised using intensity-modulated rather than 3-D conformal RT for esophageal cancer patients because it appeared to induce fewer cardiac complications. They also suggested using lower radiation doses in patients with esophageal cancer.
4 4 GENERAL THORACIC T HORACIC S URGERY N EWS SEPTEMBER/OCTOBER 2007 Mesothelioma Survival Resection from page 1 riod, according to Dr. Flores. There is confusion about which is the better surgery, EPP or P/D. I d say the goal is a macroscopic, complete resection [R1], regardless of which procedure is used, commented Dr. David J. Sugarbaker, chief of thoracic surgery at the Dana-Farber Cancer Institute in Boston. The review by Dr. Flores and his associates included all patients who underwent surgery for a malignant, pleural mesothelioma at any of three U.S. centers during : Memorial Sloan-Kettering; the National Cancer Institute in Bethesda, Md.; or the Karmanos Cancer Institute in Detroit. The average patient age was 63 years. Among the 385 patients who had EPP, the median survival was 12 months, and among the 278 patients treated with P/D, the median survival was 16 months. This suggests that P/D produces better outcomes, but use of the two alternatives was skewed based on tumor stage, according to Dr. Flores. Those patients who had a P/D tended to more commonly have lower-stage tumors, with EPP used for higher-stage tumors. In a Cox proportional hazard regression analysis that controlled for tumor stage and histology type, patients treated with EPP had a 20% higher risk of death, compared with patients treated with P/D, a difference that reached statistical significance but wasn t highly significant (P = 0.04). Mesothelioma histology and tumor stage were both more powerful, independent predictors of survival in the same analysis. A nonepithelioid histology was linked with a 50% increased risk of death, and having stage 3 or 4 cancer was associated with a 90% increased risk of death. Both of these links were highly significant, with P values of less than.001. The data also confirmed that patients treated with EPP who develop recurrent disease were more likely to have a distant recurrence (66% of all recurrences in this subgroup), whereas patients treated with P/D were more likely to have a local recurrence (65% of all recurrences in the P/D subgroup). The results emphasized the similar survival with both EPP and P/D, Dr. Flores said. If an R1 resection is not possible with P/D, then EPP is the procedure of choice. PET Can Influence Management in Esophageal Cancer WASHINGTON Positron emission tomography findings significantly altered the course of disease management in more than one-third of a group of patients with potentially curable esophageal and gastroesophageal cancers, according to findings from a prospective, multicenter, singlearm study presented at the annual meeting of the Society of Nuclear Medicine. Dr. Barry E. Chatterton of Royal Adelaide Hospital, South Australia, and colleagues reported that PET influenced the management of 38% of 129 patients with confirmed esophageal cancers (squamous cell carcinoma or adenocarcinoma) whose disease had already been diagnosed with conventional imaging (barium study, endoscopy, or CT). Patients were referred from five hospitals, and all had undergone endoscopy and biopsy, with proven histology. Most patients were male (104 patients), and the mean age was 67 years (range 36-87). Most tumors were in the distal esophagus. Referring physicians were asked for their management plans before and after receiving the PET results and were asked whether the treatment goal was cure or palliation. Impact of the PET results on disease management was classified as none, low, medium, or high. PET revealed 148 additional lesions in 53 (41%) of the 129 patients. For an additional 22% of the total population, disease was upstaged from M0 to M1. PET also detected local metastasis in 70% of patients and distant metastasis in 44% of patients, compared with 67% and 33%, respectively, in a subset of 20 patients who also underwent endoscopic ultrasound. The impact on disease management was considered medium to high in 38% of cases. Curative intent was changed to palliative intent in 20% based on PET results, and from palliative to curative in 3%. Surprisingly, Dr. Chatterton said, there was no difference in progression-free survival between patients with high and low standardized uptake values. He cautioned that these results do not in his view warrant replacement of CT or ultrasound by PET, because a lot of the patients with widespread disease were excluded by diagnostic CT beforehand.... So I don t think it will be regarded as the initial imaging study after biopsy. John R. Bell
6 6 GENERAL THORACIC T HORACIC S URGERY N EWS SEPTEMBER/OCTOBER 2007 Wake Up and Breathe Protocol Improves ICU Outcomes BY ROBERT FINN S AN F RANCISCO Medical ICU patients leave the hospital more than 4 days early if they receive spontaneous awakening trials and spontaneous breathing trials every day, according to a study reported by Dr. E. Wesley Ely at the International Conference of the American Thoracic Society. The multicenter, controlled ABC (awakening, breathing, controlled) trial involved 335 patients randomized to either standard goal-directed sedation or the awakening, breathing approach. This protocol consists of: 1) daily attempts to halt sedation spontaneous awakening trials; combined with 2) daily assessment of patients while breathing on their own spontaneous breathing trials. Compared with the control patients, the ABC trial patients left the ICU an average of 3.8 days sooner (9.1 days vs days), were discharged from the hospital 4.4 days sooner (14.8 days vs days), and spent 3.1 more days off the ventilator (14.7 days vs days). There was no significant difference in the percentage of patients who survived for 28 days or more (72% for the ABC patients, 65% for controls). When you reduce the length of stay by 4 days, that s a huge deal, Dr. Ely of Vanderbilt University, Nashville, Tenn., said in a press briefing. You can save somewhere in the neighborhood of $5,000-$15,000 per patient via protocols like this. This could have billions of dollars of implications for health care. Earlier studies had demonstrated that daily breathing trials improved the outcomes of ventilated patients, and that a daily lifting of medically induced comas improved the outcomes of patients in critical care. This was the first trial to put both of those protocols together. For years we have not optimized the removal of those sedatives, analgesics, and the ventilator, Dr. Ely said. Instead, we allow the patients on average to probably get 2 or 3 days of additional unnecessary time on the ventilator, all the while being exposed to these high doses of very potent psychoactive drugs.... I think in general that it is safe to assume that on average patients receive too long of a duration and too high of a dose of these medicines, and while it s well intentioned,... I think we re overshooting. People generally think of these drugs as not harmful, but we re actually finding that ICU delirium, which is a result of these drugs, is a very important predictor of death. The ABC protocol is easy to implement in most patients, Dr. Ely said. All it takes is the will to make the change among the physicians, nurses, and respiratory therapists who manage patients in the ICU. About half the patients enrolled in the trial had sepsis or acute respiratory distress syndrome. Other common diagnoses were myocardial infarction/congestive heart failure, chronic obstructive pulmonary disease/asthma, and altered mental status. Surgical ICU patients were excluded from the study because the investigators did not want to discontinue analgesia in patients with incisions. Dr. Ely emphasized patients must be watched closely. A very important point here is that we did not sacrifice patient comfort, he said. If patients exhibited signs of distress such as rapid breathing or sweating, sedation and analgesia were resumed, beginning at half the previous dose. Dr. Ely instead described this approach as a guideline, a default set of parameters to follow. Physicians would take this default plan and use their best clinical judgment to decide whether an individual patient might require something different. Shorter ICU, Hospital Stays With ABC Approach 9.1 days Awakening, breathing, controlled approach ICU 12.9 days Note: Based on a study of 335 medical ICU patients. Source: Dr. Ely Standard goaldirected sedation 14.8 days Hospital 19.2 days ELSEVIER GLOBAL MEDICAL NEWS
7 SEPTEMBER/OCTOBER 2007 T HORACIC S URGERY N EWS GENERAL THORACIC 7 Transhiatal Esophagectomy Stands the Test of Time BY BRUCE JANCIN C OLORADO S PRINGS Dr. Mark B. Orringer can vividly recall the skeptical reception he received when, as a young surgeon in 1978, he presented to some of the nation s most illustrious surgeons his thenrevolutionary concept of esophagectomy without thoracotomy, the operation he named transhiatal esophagectomy. It was a tough crowd. The late Dr. Alton Ocshner of New Orleans dismissed the concept of transhiatal esophagectomy and said, Taking out the esophagus without opening the chest is like trying to make love in a hammock standing up. At this year s annual meeting of the American Surgical Association, Dr. Orringer shared lessons learned in performing 2,007 transhiatal esophagectomies (THEs) over a 30-year period at the University of Michigan, Ann Arbor, where he is professor of surgery and head of the section of thoracic surgery. Recalling Dr. Ocshner s quip, he told his colleagues he has now made love in a hammock a great many times, and he assured them it is a very fine thing to do. While he initially believed he came up with THE in 1976, Dr. Orringer said he later learned he had independently rediscovered an operation first described 63 years earlier in Germany. Summarizing his 30-year experience with the procedure, he said THE was possible in 98% of patients requiring esophagectomy. The stomach was used to create the substitute esophagus in 97% of cases. Esophageal resection and reconstruction were performed as a single operation 97% of the time. A total of 76% of THEs were performed for cancer, the remainder for benign disease. Nearly 30% of THEs for benign disease were for neuromotor esophageal dysfunction, primarily achalasia. At a prior ASA meeting, Dr. Orringer presented the results of the first 1,063 patients to undergo THE, during A comparison of outcomes between those patients (group 1) and the next 944 THE patients through 2006 (group 2) showed sharp drops in hospital mortality 4% in the first group, 1.3% in the second and anastomotic leak 14% vs. 5%. Median intraoperative blood loss fell from 677 to 368 cc. Discharge within 10 days occurred in 52% of patients in group 1 and in 76% in group 2. Dr. Orringer attributed the improved outcomes to surgical refinements such as the use of side-to-side stapled cervicalesophagogastric anastomosis and a ban on metal against the tracheoesophageal groove, along with greater operative experience and the introduction of clinical pathways. Experience does count in this operation, he stressed. The incidence of recurrent laryngeal nerve injury after THE is clearly influenced by operator volume: It was 32% when we were performing 23 operations annually and a consistent 1%- 2% since reaching an annual volume of 80 or more. Aggressive preoperative conditioning also plays a role. Patients must abstain from smoking for 3 weeks before surgery, use a spirometer, and walk 1-3 miles daily. In group 1, a postoperative ICU stay was routine, while only 4% of patients in group 2 went to the ICU. Extubation in the operating room, reliance upon epidural anesthesia to facilitate pulmonary hygiene, and aggressive ambulation starting on day 1 have nearly eliminated the need for postop intensive care. The histology of esophageal cancer has changed over time. It was adenocarcinoma in 69% of patients in group 1, compared with 86% of patients in group 2. IN THE TREATMENT OF ACUTE HYPERTENSION, CHOOSE INTRAVENOUS THERAPY THAT IS... STEADY UNDER PRESSURE Indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable 1 A pure afterload reducer...decreases systemic vascular resistance 1,2 Efficacy comparable to sodium nitroprusside without as many dose adjustments and lower risk of hypotension 3,4 Rapid onset of therapeutic activity with blood pressure reductions in 10 to 12 minutes 1 Predictable titration and ease of administration 1 Hemodynamic studies demonstrate significant increases in ejection fraction and cardiac output 1 For more information, please visit References: 1. CARDENE I.V. [prescribing information]. Fremont, CA: PDL BioPharma, Inc; Neely CF. Postoperative hypertension. In: Goldmann DR, Brown FH, Guarnieri DM, eds. Perioperative Medicine The Medical Care of the Surgical Patient. 2nd ed. New York, NY: McGraw-Hill; 1994: Neutel JM, Smith DHG, Wallin D, et al. A comparison of intravenous nicardipine and sodium nitroprusside in the immediate treatment of severe hypertension. Am J Hypertens. 1994;7: Halpern NA, Goldberg M, Neely C, et al. Postoperative hypertension: a multicenter, prospective, randomized comparison between intravenous nicardipine and sodium nitroprusside. Crit Care Med. 1992;20: Important safety information Close monitoring of the blood pressure is required during therapy. CARDENE I.V. is contraindicated in patients with known hypersensitivity to the drug and in patients with advanced aortic stenosis. Reduction of diastolic pressure and reduced afterload may worsen rather than improve myocardial oxygen balance. Caution is advised when administering CARDENE I.V. to patients with impaired renal or hepatic function, in combination with a beta-blocker in patients with congestive heart failure, or portal hypertension. Observe caution in patients with significant left ventricular dysfunction due to possible negative inotropic effect. CARDENE I.V. gives no protection against the dangers of abrupt beta-blocker withdrawal; beta-blocker dosage should be gradually reduced. Levels of cyclosporine should be closely monitored during therapy. The most common side effects of CARDENE I.V. are headache (14.6%), hypotension (5.6%), nausea/vomiting (4.9%), and tachycardia (3.5%). Less frequent adverse effects, in each case occurring at 1.4%, include ECG abnormalities, postural hypotension, ventricular extrasystoles, injection-site reaction, dizziness, sweating and polyuria. Please see next page for brief summary of prescribing information PDL BioPharma, Inc. CAR0163 6/07 Redwood City, CA All rights reserved. The prevalence of Barrett s mucosa with high-grade dysplasia has climbed from 19% to 44% over the years. In the current epidemic, the dominant etiology of esophageal cancer is not alcohol, but rather obesity causing hiatal hernia, reflux, and Barrett s metaplasia, Dr. Orringer observed. Discussant Dr. Carlos A. Pellegrini, professor and chairman of surgery at the University of Washington Medical Center, Seattle, characterized the lack of formal en bloc lymphadenectomy as the Achilles heel of THE in patients with esophageal cancer. How, he asked, can patients accurately be staged without it? Dr. Orringer conceded that the lack of staging lymphadenectomy in THE was a problem in the past, but the ability to stage patients has been vastly improved through the use of CT and PET scans as well as endoscopic ultrasound as part of the routine work-up of patients with esophageal cancer. All papers presented at the meeting of the ASA are subsequently submitted to the Annals of Surgery for consideration. TIMELY. TARGETED. CONSISTENT.
8 8 GENERAL THORACIC T HORACIC S URGERY N EWS SEPTEMBER/OCTOBER 2007 Biomarkers Predict Progression to Esophageal Cancer BY ROBERT FINN L OS A NGELES A combination of three biomarkers may reliably predict which patients with Barrett s esophagus will progress to esophageal adenocarcinoma, Dr. Patricia L. Blount reported at the annual meeting of the American Association for Cancer Research. In a study involving 243 patients with Barrett s esophagus, 79.1% of patients who had all three genetic abnormalities on Brief Summary of Prescribing Information INDICATION AND USAGE: For the short-term treatment of hypertension when oral therapy is not feasible or desirable. For prolonged control of blood pressure, patients should be transferred to oral medication as soon as their clinical condition permits. CONTRAINDICATIONS: In patients with known hypersensitivity. Cardene I.V. is also contraindicated in patients with advanced aortic stenosis because part of the effect of Cardene I.V. is secondary to reduced afterload. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance. WARNINGS: BETA-BLOCKER WITHDRAWAL: Nicardipine is not a beta-blocker and provides no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of dose of beta-blocker. RAPID DECREASES IN BLOOD PRESSURE: No clinical events have been reported suggestive of a too rapid decrease in blood pressure with Cardene I.V. However, as with any antihypertensive agent, blood pressure lowering should be accomplished over as long a time as is compatible with patient s clinical status. USE IN PATIENTS WITH ANGINA: Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with Cardene I.V. Increased frequency, duration, or severity of angina has been seen with chronic oral Cardene therapy. USE IN PATIENTS WITH CONGESTIVE HEART FAILURE: Cardene I.V. reduced afterload without impairing myocardial contractility in preliminary hemodynamic studies of CHF patients. However, in vitro and in some patients, a negative inotropic effect has been observed. Exercise caution when using Cardene I.V., particularly in combination with a beta-blocker, in patients with CHF or significant left ventricular dysfunction. USE IN PATIENTS WITH PHEOCHROMOCYTOMA: Limited clinical experience exists in these patients; therefore, exercise caution when administering Cardene I.V. PERIPHERAL VEIN INFUSION SITE: To minimize the risk of peripheral venous irritation, it is recommended that the site of infusion of Cardene I.V. be changed every 12 hours. PRECAUTIONS: GENERAL: Blood pressure: Because Cardene I.V. decreases peripheral resistance, monitoring of blood pressure during administration is required. Cardene I.V., like other calcium channel blockers, may occasionally produce symptomatic hypotension. Caution is advised to avoid systemic hypotension when administering the drug to patients who have sustained an acute cerebral infarction or hemorrhage. Use in Patients with Impaired Hepatic Function: Nicardipine is metabolized in the liver; exercise caution in patients with impaired liver function or reduced hepatic blood flow; consider use of lower dosages. Nicardipine administered intravenously has been reported to increase hepatic venous pressure gradient by 4 mm Hg in cirrhotic patients at high doses (5 mg/20 min). Use Cardene I.V. with caution in patients with portal hypertension. Use in Patients with Impaired Renal Function: When Cardene I.V. was given to mild to moderate hypertensive patients with moderate renal impairment, a significantly lower systemic clearance and higher AUC was observed. These results are consistent with those seen after oral administration of nicardipine. Careful dose titration is advised when treating renally-impaired patients. DRUG INTERACTIONS: Since Cardene I.V. may be administered to patients already being treated with other medications, including other antihypertensive agents, careful monitoring of these patients is necessary to detect and promptly treat any undesired effects from concomitant administration. Beta-Blockers: In most patients Cardene I.V. can safely be used with beta-blockers. However, exercise caution when using this combination in CHF patients (see WARNINGS). Cimetidine: Cimetidine has been shown to increase nicardipine plasma concentrations following Cardene capsule administration; carefully monitor concomitant use. Data with other histamine-2 antagonists are not available. Digoxin: Studies have shown that Cardene capsules usually do not alter digoxin plasma concentrations; however, as a precaution, evaluate digoxin levels when initiating concomitant Cardene I.V. therapy. Fentanyl anesthesia: Hypotension has been reported during fentanyl anesthesia with concomitant use of a beta-blocker and a calcium channel blocker. Even though such interactions were not seen during clinical studies with Cardene I.V. (nicardipine hydrochloride), an increased volume of circulating fluids might be required if such an interaction were to occur. Cyclosporine: Concomitant use of Cardene capsules and cyclosporine results in elevated plasma cyclosporine levels. Monitor cyclosporine plasma levels closely and reduce its dose accordingly. In vitro interaction: The plasma protein binding of nicardipine was not altered when therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine, or naproxen were added to human plasma in vitro. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Rats treated with nicardipine in the diet (at doses of 5, 15, or 45 mg/kg/day) for two years showed a dose-dependent increase in thyroid hyperplasia and neoplasia (follicular adenoma/carcinoma). One- and three-month rat studies have suggested that these results are due to a nicardipine-induced reduction in plasma thyroxine (T 4) levels, with resultant increase in plasma levels of thyroid stimulating hormone (TSH). Mice treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of up to 100 mg/kg/day) for up to 18 months showed no evidence of neoplasia of any tissue and no evidence of thyroid changes. There was no evidence of nicardipine-induced thyroid effects in dogs (treated with nicardipine at doses up to 25 mg/kg/day for one year) or in man. Nicardipine did not display mutagenic potential in genotoxicity tests conducted in microbes, mice and hamsters. No fertility impairment was seen in male or female rats administered oral nicardipine doses as high as 100 mg/kg/day (50 times the 40 mg TID maximum recommended human dose [MRHD] in man, assuming a patient weight of 60 kg). PREGNANCY CATEGORY C: There are no adequate and well-controlled studies in pregnant women; Cardene I.V. should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Cardene I.V. administered at doses up to 5 mg/kg/day and up to 0.5 mg/kg/day to pregnant rats and rabbits, respectively, produced no embryotoxicity or teratogenicity. Embryotoxicity, but not teratogenicity, was seen at 10 mg/kg/day in rats and at 1 mg/kg/day in rabbits. Nicardipine was embryocidal at oral doses of 150 mg/kg/day, given during organogenesis, to pregnant white rabbits but not at 50 mg/kg/day (25 times MRHD). No adverse effects on the fetus were observed when albino rabbits were treated, during organogenesis, with up to 100 mg/kg/day of nicardipine. Pregnant rats receiving oral doses up to 100 mg/kg/day (50 times MRHD) showed no evidence of embryolethality or teratogenicity. However, dystocia and reductions in birth weights, neonatal survival, and neonatal weight gain were noted. There are no adequate and well-controlled studies in pregnant women. Cardene should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. NURSING MOTHERS: Studies in rats have shown significant concentrations of nicardipine in maternal milk. Therefore, use in nursing mothers is not recommended. PEDIATRIC USE: Safety and efficacy in patients under the age of 18 have not been established. USE IN THE ELDERLY: In clinical studies, no significant difference was observed in the antihypertensive effect of Cardene I.V. in patients 65 years compared to other adult patients. ADVERSE EXPERIENCES: 244 patients participated in two multicenter double-blind, placebo-controlled trials of Cardene I.V. Adverse effects were generally not serious and most were expected effects of vasodilation. Some adverse effects required dosage adjustments. Therapy was discontinued in approx. 12% of patients due mainly to hypotension, headache and tachycardia. The following numbers represent percentage of patients with adverse experiences during the double-blind portion of controlled trials with Cardene I.V. (n=144) versus Placebo (n=100), respectively. Percent of Patients with Adverse Experiences During the Double-Blind Portion of Controlled Trials Adverse Experience Cardene (n=144) Placebo (n=100) Body as a Whole Headache Asthenia Abdominal pain Chest pain Cardiovascular Hypotension Tachycardia ECG abnormality Postural hypotension Ventricular extrasystoles Extrasystoles Hemopericardium Hypertension Supraventricular tachycardia Syncope Vasodilation Ventricular tachycardia Digestive Nausea/vomiting Injection Site Injection site reaction Injection site pain Metabolic and Nutritional Hypokalemia Nervous Dizziness Hypesthesia Intracranial hemorrhage Paresthesia Respiratory Dyspnea Skin and Appendages Sweating Urogenital Polyuria Hematuria RARE EVENTS: The following events have been reported in clinical trials or in the literature with intravenous use of nicardipine. Body as a Whole: fever, neck pain. Cardiovascular: angina pectoris, atrioventricular block, ST segment depression, inverted T wave, deep vein thrombophlebitis. Digestive: dyspepsia. Hemic and Lymphatic: thrombocytopenia. Metabolic and Nutritional: hypophosphatemia, peripheral edema. Nervous: confusion, hypertonia. Respiratory: respiratory disorder. Special Senses: conjunctivitis, ear disorder, tinnitus. Urogenital: urinary frequency. Sinus node dysfunction and myocardial infarction, possibly due to disease progression, have been seen in patients on chronic oral nicardipine therapy. OVERDOSAGE: Several overdosages with orally administered nicardipine have been reported. One adult patient allegedly ingested 600 mg of nicardipine (standard [immediate release] capsules), and another patient, 2160 mg of the sustained release formulation of nicardipine. Symptoms included marked hypotension, bradycardia, palpitations, flushing, drowsiness, confusion and slurred speech. All symptoms resolved without sequelae. An overdosage occurred in a one year old child who ingested half of the powder in a 30 mg nicardipine standard capsule. The child remained asymptomatic. Based on results obtained in laboratory animals, lethal overdose may cause systemic hypotension, bradycardia (following initial tachycardia) and progressive atrioventricular conduction block. Reversible hepatic function abnormalities and sporadic focal hepatic necrosis were noted in some animal species receiving very large doses of nicardipine. For treatment of overdosage, standard measures including monitoring of cardiac and respiratory functions should be implemented. The patient should be positioned so as to avoid cerebral anoxia. Frequent blood pressure determinations are essential. Vasopressors are clinically indicated for patients exhibiting profound hypotension. Intravenous calcium gluconate may help reverse the effects of calcium entry blockade. DOSAGE AND ADMINISTRATION: DOSAGE MUST BE INDIVIDUALIZED depending on severity of hypertension and patient response. Monitor blood pressure during and after the infusion; avoid too rapid or excessive reductions in systolic or diastolic blood pressure. WARNING: AMPULS MUST BE DILUTED BEFORE INFUSION. Cardene I.V. is administered by slow continuous intravenous infusion at a CONCENTRATION OF 0.1 mg/ml. Dilute each ampul (25 mg) with 240 ml of compatible intravenous fluid (see full prescribing information), resulting in 250 ml of a 0.1 mg/ml solution. NOTE: Cardene I.V. is NOT compatible with Sodium Bicarbonate (5%) Injection, USP, or Lactated Ringer s Injection, USP. See package insert for full prescribing information. Reference: 1. Whiting RL. Animal pharmacology of nicardipine and its clinical relevance. Am J Cardiol. 1987;59:3J-8J. For questions of a medical nature call Cardene I.V. is a registered trademark of Hoffman-La Roche Inc. Manufactured under license from Roche Palo Alto LLC by: Baxter Healthcare Corporation Deerfield, IL USA Marketed by: PDL BioPharma, Inc. Fremont, CA USA Issued January baseline endoscopic biopsy progressed to esophageal adenocarcinoma within 6 years. Conversely, among patients who had none of the abnormalities, there was not a single progression to cancer in almost 8 years. Progression rates for patients with one and two abnormalities were 5.7% and 28.4%, respectively, at 6 years. Compared with patients with no abnormalities, patients with any two of the abnormalities were nine times more likely to progress to esophageal adenocarcinoma, and those with all three of the abnormalities were 39 times more likely to progress during an average follow-up of 71 months; these differences were statistically significant. Patients with one abnormality were 1.8 times more likely to progress than those with no abnormalities, but this was not a significant difference. Dr. Blount, director of the Clinical Research Core of the Seattle Barrett s Esophagus Research Program, noted that it s important to try to predict which patients will progress to esophageal cancer. Only about 10% of patients with gastro- esophageal reflux disease progress to Barrett s esophagus, and only about 10% of patients with Barrett s esophagus progress to esophageal adenocarcinoma. These are very exciting, promising data, commented Dr. Rhonda Souza, of the gastroenterology faculty at the University of Texas, Dallas. These biomarker tests are not ready for routine clinical use, but the findings provide evidence that there s a place for them in the future, added Dr. Souza, also of the Dallas VA Medical Center. Maybe adding biomarkers could help us select a subgroup of patients for more intensive surveillance from the larger group of patients with Barrett s esophagus being monitored via endoscopy, Dr. Souza said. But first, these markers should be studied in a prospective, randomized trial, she noted. Dr. Yvonne Romero, of the division of gastroenterology at the Mayo Clinic, Rochester, Minn., agrees. This is a very exciting development. At present, our best predictive marker for cancer is high-grade dysplasia. Dysplasia is the pathology proxy we use to estimate genomic instability. About 30% of patients with high-grade dysplasia will progress to cancer within 5 years. What is not yet clear is exactly how we will use the new information. Right now, if a patient has no dysplasia on two examinations performed a year apart, the American College of Gastroenterology guidelines suggest we increase the surveillance interval to 3-5 years. If the biomarkers return as three of three positive, will we alter the recommendation to continued annual surveillance instead? In conducting the research, the investigators considered the contributions of seven different genetic abnormalities in an effort to determine which were independently associated with disease progression. They focused on DNA aneuploidy and tetraploidy and on alterations in the genes for the tumor-suppressor proteins TP53 and CDKN2A accompanied by a loss of heterozygosity (LOH) for those genes. It turned out that patients who had either aneuploidy or tetraploidy, 17p LOH (loss of heterozygosity on the short arm of chromosome 17), or 9p LOH (similarly, on chromosome 9) were more likely to progress to cancer. The tumor-suppressor proteins are encoded on the short arms of chromosome 17 and chromosome 9. In addition, the investigators focused on whether current use of aspirin or other NSAIDs affected progression to esophageal adenocarcinoma. As in other studies, the results of this study suggested that the use of NSAIDs may be protective. Among patients who had two or more abnormal biomarkers, those who did not use NSAIDs at baseline had a 68% cumulative risk of progressing to cancer. Similar patients who did use NSAIDs at least 1 day a week for 6 months in the year preceding their endoscopy had only a 30% risk of progressing to cancer, a significant difference. The protective effect of NSAIDs was not apparent among patients with no abnormal biomarkers or just one, perhaps because their overall cancer risk was relatively low.
9 NEW Kimberly-Clark* InteguSeal* Microbial Sealant Lock down skin pathogens Sealed bacteria Lock out contamination worries Introducing a first-in-class microbial barrier designed to seal and immobilize bacteria, reducing the risk of skin flora contamination Skin pathogens are a key factor in the development of surgical site infections (SSIs). 1 In cardiac surgery, SSIs are associated with a mortality rate as high as 29%. 2 New Kimberly-Clark* InteguSeal* Microbial Sealant: Helps protect the incision against migration of pathogens that reside deep in the skin and that may survive typical pre-op prepping Significantly reduces recovery of bacteria, such as MRSA, S. epidermis and E. coli, by over 99% 3 Employs a safe, breathable cyanoacrylate technology InteguSeal* makes skin flora contamination less worrisome. At Kimberly-Clark, our mission is to deliver clinical solutions that help the surgical team reduce SSIs. To find out more, please visit References: 1. Hagen KS, Treston-Aurand J. A comparison of two skin preps used in cardiac surgical procedures. AORN J. 1995; 62(3): Lepelletier D, Perron S, Bizouaran P, et al. Surgical-site infection after cardiac surgery: incidence, microbiology, and risk factors. Infect Control Hosp Epidemiol. 2005;26: Data on file. Kimberly-Clark Health Care. *Registered Trademark or Trademark of Kimberly-Clark Worldwide, Inc KCWW.
10 10 T HORACIC S URGERY N EWS SEPTEMBER/OCTOBER 2007 N E W S F R O M T H E A S S O C I A T I O N The WTSA 2007 Annual Meeting in Review The 33rd Annual Meeting of the Western Thoracic Surgical Association was held at the Hyatt Regency Tamaya Resort in Santa Ana Pueblo, New Mexico, on June 27-30, The Meeting included oral presentation of 22 original papers, panel discussions, a postgraduate course, breakfast sessions, and 24 concurrent brief communications in the disciplines of adult cardiac, general thoracic, and congenital heart disease. The annual meeting attracted more than 170 physicians and provided an excellent didactic scientific program with many opportunities for questions and open discussion and an overall perspective of current practices. Educational highlights of the program included a Controversies in Thoracic Surgery session that debated The Solitary Pulmonary Nodule: Excision vs. Ablation Do you Need to Know moderated by Richard I. Whyte, with Douglas Wood arguing for and James D. Luketich against. Simultaneous breakfast sessions were held in the three disciplines. Adult Cardiac focused on Percutaneous Valves with invited speaker Jian Ye. The General Thoracic Session was entitled The Evolution of Therapy for Achalasia: Surgery is the Treatment of Choice with speaker Donald E. Low. The Congenital Heart Disease Session, with speakers Ivan Rebeyka and Jeffrey Smallhorn, focused on How to Use 3D Echo to Improve Atrioventricular Valve Repair in Pediatric Cardiac Surgery. The C. Walton Lillehei Point/Counterpoint Session debated whether Technology Has Compromised the Maze Procedure and was moderated by Steven Guyton with Robbin G. Cohen arguing in favor and Steven R. Gundry opposing. The Postgraduate AATS 2008 Annual Meeting Call for Abstracts Abstracts for presentation at the 2008 Annual Meeting of the American Association for Thoracic Surgery are now being accepted. Mark your calendar now for this five-day educational program, to be held May 10-14, 2008, at the San Diego Convention Center, California. For more info, and to submit an abstract visit: AATS Meetings and Sponsored Events More information can be accessed at October 18-20, st Century Treatment of Heart Failure: Synchronizing Surgical and Medical Therapies for Better Oucomes Intercontinental Hotel & Bank of America Conference Center, Cleveland, Ohio March 13, 2008 AATS/ASCVTS Adult Cardiac and Congenital Postgraduate Course Directed by Craig R. Smith, M.D. Singapore Course, sponsored by White Memorial Medical Center and Foundation Lyman A. Brewer, III, Fund, featured Philip F. Halloran from Edmonton, Canada, presenting Frontiers in Disease Phenotyping: The Example of Organ Transplantation. Additional highlights included the Presidential Address by Elliot T. Gelfand entitled In Celebration of Our Differences. The David J. Dugan Distinguished Service Award was presented to W. Gerald Rainer from Denver, Colorado. Dr. Rainer was honored for his outstanding contributions to thoracic surgery over the years. Several additional awards were also presented. The Donald B. Doty Educational Award was given to Gordon A. Cohen of Seattle, Washington. The Norman E. Shumway Award for the Best Paper given by a WTSA member was awarded to M.J. Weyant of Denver for his presentation Secretory Phospholipase A2 is Required to Induce Histologic Changes Associated with Gastroesophageal Reflux in a Murine Model. The Samson Resident Prize Essay Award was given to both Jayan Nagendran from the University of Alberta for his paper, Mitochodrial Membrane Potential is Different Between the Right and Left Ventricle in Humans and Rats and Patrick S. Wolf from the University of Washington for his paper MAP Kinase Inhibition Ameliorates Lung Ischemia- Reperfusion Injury. The Officers elected during the meeting include: President Douglas E. Wood, annualmeeting/index.html. The Web site has instructions for electronic abstract submission and information about the 2008 program. We look forward to reviewing your original research. Electronic submissions only, please. Deadline: Monday, 11:59 AM EST, October 1, May 8-9, 2008 Aortic Surgery Symposium XI Directed by Randall B. Griepp, M.D. and Steven L. Lansman, M.D. Sheraton New York, New York May 10-14, th Annual Meeting San Diego Convention Center San Diego, California October 23-24, th Triennial Brigham Cardiac Valve Symposium Directed by R. Morton Bolman, III, M.D. Fairmont Copley Plaza Hotel Boston, Massachusetts Seattle, Washington; Vice President David A. Fullerton, Denver, Colorado; Immediate Past President Elliot T. Gelfand, Edmonton, Alberta, Canada; Secretary John A. Hawkins, Salt Lake City, Utah; Treasurer Robbin G. Cohen, Los Angeles, California; Councillor/Founder Arthur N. Thomas, Hillsborough, California; Historian Marvin Pomerantz, Denver, Colorado; Governor, American College of Surgeons Gabriel S. Aldea, Seattle, Washington; Editor Andrew S. Wechsler, Philadelphia, Pennsylvania; and Councillors-at-Large John C. Chen, Honolulu, Hawaii, David M. Follette, Sacramento, California, and Robert C. Robbins, Stanford, California. New Mexico provided a wonderful setting for the week s activities, including the New Member s Reception around the Resort s Pool Area and Lawn, the golf and tennis tournaments, the Samson Fun Run along the banks of the Rio Grande River, a Route 66 Theme Dinner, and the traditional President s Reception and Banquet. Elliot T. Gelfand, M.D. (left), congratulates incoming Western Thoracic Surgical Association President Douglas E. Wood, M.D. Treatment of Heart Failure Course Coming in October 21 st Century Treatment of Heart Failure: Synchronizing Surgical and Medical Therapies for Better Outcomes will be held October 18-20, 2007, at the Bank of America Conference Center in the Cleveland Clinic Intercontinental Hotel, Cleveland, Ohio. Heart failure is making news. Innovative treatments, breakthrough research, and epidemiological insights have inspired three of America s leading cardiovascular specialty organizations to collaborate on a landmark learning experience for medical professionals who treat heart failure. This historic meeting is the first educational event ever sponsored by the Kaufman Center for Heart Failure at Cleveland Clinic in partnership with the American Association for Thoracic Surgery (AATS) and the American College of Cardiology Foundation (ACCF). Together they offer the most advanced review of emerging medical and surgical treatments of heart failure available today. 21 st Century Treatment of Heart Failure will feature presentations by leading experts in cardiovascular medicine and cardiac surgery. Topics will include: new therapies to reverse remodeling; drugs, genes, and cellular targets; the newest assist devices, with an update on the total artificial heart and rotary pumps; the latest treatment guidelines; breakthrough findings on the epidemiology of systolic and diastolic heart failure.... and much more. 21 st Century Treatment of Heart Failure coincides with the 50 th anniversary of the development of the artificial heart at Cleveland Clinic. Don t miss this remarkable collaboration between the AATS, the AACF and the Kaufman Center for Heart Failure at Cleveland Clinic. The combination of presenters and topics promises the liveliest, most enlightening and most provocative meeting yet. 21 st Century Treatment for Heart Failure convenes at the Bank of America Conference Center at the Intercontinental Hotel on the Cleveland Clinic campus. This astounding 500-seat amphitheater combines state-of-the-art visual technology, with unmatched comfort and interactive communication. You are urged to take advantage of this learning opportunity. This activity has been approved for AMA Category 1 Credits. THE WESTERN THORACIC SURGICAL ASSOCIATION
11 SEPTEMBER/OCTOBER 2007 T HORACIC S URGERY N EWS 11 N E W S F R O M T H E A S S O C I A T I O N 2008 AATS Intern Applications Online Deadline to Apply: January 15, 2008 The American Association for Thoracic Surgery is now accepting applications for the 2008 Medical Student Summer Internship program. In its second year, the program is expected to provide up to 50 North American medical students with an opportunity to broaden their education experience by working in a local cardiothoracic surgery department. Successful candidates will receive a grant of $5,000 to underwrite their living expenses for an eight-week internship in a local cardiothoracic surgery program. Candidates must be a first or second year medical student in a North American medical school program. Sponsor must be a Member of the AATS and provide the applicant with a letter of support. Candidates must complete an online application by January 15, 2008, and include an outline of what they hope to accomplish during their eight-week internship. Additional award criteria can be accessed on the AATS Web site at Award announcements will be made no later than March 15, AATS Membership: Apply Now Online To apply for membership in the American Association for Thoracic Surgery, an Active or Senior member of the Association must agree to act as the primary sponsor by initiating the application process in the Members Only area of the AATS Web site (www.aats.org). The online application form will need to be acknowledged by two additional sponsors who are Senior or Active members of the Association. All three sponsors will also be required to submit letters of recommendation on behalf of the applicant. Current members of the Membership Committee may not act as sponsors. Prospective applicants will be evaluated according to his/her current environment, future expectations, and training record. Specific qualifications reviewed for membership include accomplishments in clinical performance, professional stature, professional conduct, leadership advancing the discipline, and contributions to surgical literature in English language peer reviewed journals. Active membership (to age 70) is limited to 600 members. Deadline for online submission of applications: November 30, Aortic Symposium 2008 Call for Abstracts Course chairs Randall B. Griepp, M.D., and Steven L. Lansman, M.D., have announced that abstracts representing videos for presentation are now being accepted for the 2008 Aortic Symposium. The 2008 Aortic Symposium, sponsored by the AATS, will primarily feature How To Do It videos. Mark your calendar now for this two-day postgraduate course: May 8-9, 2008, Sheraton New York Hotel & Towers, New York City. This course will be held immediately prior to the 88th Annual Meeting of the AATS, on May 10-14, 2008, in San Diego, California. The abstract submission site contains complete submission instructions and guidelines and can be accessed at Submission Deadline: Friday, December 14, Please keep checking for news and updates regarding the Aortic Symposium We look forward to seeing you next year in New York City!
12 12 ADULT CARDIAC T HORACIC S URGERY N EWS SEPTEMBER/OCTOBER 2007 Using Totally Endo Thoracoabdominal Aneurysm Repair BY MARK S. LESNEY CABG Outcomes Serum HbA 1c from page 1 measure of serum HbA 1c taken shortly before surgery. All patients were treated with a uniform and strict insulin-infusion regimen during the intraoperative and perioperative periods to try to maintain blood glucose levels at less than 120 mg/dl. A total of 2,275 patients (74%) had a preoperative HbA 1c level lower than 7%, and 814 (26%) had a level of 7% or higher. In addition, 1,240 patients (40%) were diagnosed with diabetes or had a history of diabetes before surgery, and 1,849 (60%) had no history of diabetes. Among the patients with a history of diabetes, 42% were well controlled at the time of surgery, with an HbA 1c lower than 7%. Surgical outcomes were assessed by the incidence of five adverse events during hospitalization following surgery: death, myocardial infarction, stroke, renal failure, and deep sternal-wound infection. The incidence of four of these five adverse outcomes were all significantly reduced in the patients who had surgery with an HbA 1c level lower than 7%, compared with those with a level of 7% or higher. The only outcome that was not significantly less was myocardial infarction. (See box.) In contrast, when patients with and without a history of diabetes were compared, stroke was the only adverse outcome that was significantly more common among the patients with diabetes, Dr. Halkos said. In addition, when the incidence of adverse events was tallied only among well-controlled patients with diabetes (those with an HbA 1c level lower than 7%), the rates were not significantly different than the rates among the patients without diabetes. Another analysis of the data used HbA 1c levels as a continuous variable, instead of a dichotomous variable with the cut point at 7%. A multivariate analysis that adjusted for baseline differences among the patients showed that every 1% increase in HbA 1c level was linked with a statistically significant increase in the incidence of four of the five adverse outcomes studied following CABG. The only outcome that did not show a significant relationship was stroke. The significant increases in event rate for each 1% increase in HbA 1c were 55% for death, 66% for myocardial infarction, 18% for renal failure, and 35% for deep sternal-wound infection. Rate of Adverse Events After CABG Linked to HbA 1c Levels Myocardial infarction 0.3% 0.5% Death* 0.8% Deep sternalwound infection* Stroke* Renal failure* R esults of a small study using multibranched stent-graft implantation for thoracoabdominal aneurysm repair showed benefits indicating this technique should have an expanded role in treatment, according to Dr. Timothy A.M. Chuter. Self-expanding covered stents were used to connect the caudally-directed cuffs of an aortic stent graft with the visceral branches of an aortic aneurysm in 16 patients, according to Dr. Chuter in an interview regarding the study he and his colleagues from the University of California, San Francisco, and the Cook Australia Research Laboratory, Perth, presented at the Vascular Annual Meeting. The 11 men and 5 women were all considered unfit for open repair. Prior aortic surgery had been undergone by seven of the patients. The procedure was performed totally endovascularly in each case. The customized aortic stent grafts were inserted through surgically exposed femoral (12 patients) or iliac (4 patients) arteries. The covered stents were all inserted through surgically exposed brachial arteries. In all 16 cases, spinal catheters were used for cerebrospinal fluid pressure monitoring, and additionally for spinal anesthesia in 10 patients; the other 6 had general anesthesia, according to Dr. Chuter. Follow-up included contrastenhanced CT scans at 1 week and at 1, 6, and 12 months. In all 16 patients, the stent grafts were successfully deployed and covered an average of 78% of total aortic length from the subclavian orifice to the bifurcation, involving 57 visceral branches, Dr. Chuter stated. 0.4% 1.3% 1.6% 1.8% 2.3% 2.8% HbA 1c < 7% (n = 2,275) HbA 1c 7% (n = 814) *Statistically significant. Note: Adverse outcomes occurred during hospitalization after surgery. Source: Dr. Halkos Branched stentgrafting for TAAA is relatively new and quite different from anything else we do. DR. CHUTER 4.9% ELSEVIER GLOBAL MEDICAL NEWS Significant perioperative complications developed in four (25%) of the patients. These included two patients, both with severe, long-standing chronic obstructive pulmonary disease, who developed pneumonia. One patient developed paraplegia and renal failure, and died after refusing dialysis; and one patient underwent successful reintervention for iatrogenic aortic dissection and type 1 endoleak. There were no strokes, myocardial infarctions, other deaths, complications, endoleaks, or reinterventions. Two patients did experience transient lower extremity weakness during periods of relative hypotension, and one renal artery occluded within a month of stent-graft implantation. The only other notable events during a mean follow-up of 180 days were one death from chronic pulmonary disease and one case of superior mesenteric artery stenosis (50%) that occurred at 6 months after stent-graft implantation, he added. All other branches (over 98%) were found to be widely patent at follow-up, and all of the aneurysms remained excluded, and the stent grafts remained intact, Dr. Chuter stated. Our results show that multibranched stent-graft implantation eliminates aneurysm flow, while preserving visceral perfusion and avoiding many of the physiologic stresses that are associated with other forms of aneurysm repair. These results support an expanded role for this technique in the BY BRUCE JANCIN D ENVER Postoperative atrial fibrillation is often dismissed as a nuisance arrhythmia whose chief impact is a prolonged stay in the hospital. But this common complication may have longterm adverse consequences. Indeed, postop atrial fibrillation (AF) within the first several days after coronary artery bypass graft surgery in patients without any history of AF was associated with nearly a twofold increased late all-cause mortality, mainly due to more deaths attributable to stroke, arrhythmias, and heart failure, Dr. Anders Ahlsson said at the annual scientific sessions of the Heart Rhythm Society. He reported on 1,443 patients who were in sinus rhythm with no history of AF or pacemaker therapy when they underwent a first CABG procedure in On postop days 1-5, 29% developed AF. They were on average more than 4 years older than those who did not; left ventricular ejection fractions in the two groups were similar. At a median of 8 years follow-up, treatment of thoracoabdominal aortic aneurysm [TAAA], Dr. Chuter and his colleagues said. Since submitting the abstract we have performed another eight operations of this type, and I have to admit we are still learning from the experience. Branched stentgraft implantation for TAAA is still relatively new and quite different from anything else we do. The medium-term advantages over conventional surgery are obvious, but the ultimate role of this technique will depend upon the long-term results. This is one of the limitations of our current study cohort who all have serious comorbid conditions and reduced life expectancy, Dr. Chuter added in the interview. Other burning issues, he said, include the anatomy and physiology of spinal blood flow after endovascular TAAA repair. Paraplegia is rare, but transient symptoms are common and worrying enough to prolong ICU stays, and the causes, and possible treatments, of consumptive coagulopathy and inflammation. We see this phenomenon after any form of endovascular aneurysm repair, but it is more severe and more prolonged after TAAA repair. Postoperative Atrial Fib May Double Long-Term Mortality all-cause mortality was 33.3% in the postop AF group and 19.2% in the comparator arm. (See box.) In a multivariate regression analysis, postop AF proved to be a risk factor for mortality independent of patient age, diabetes, and other potential confounders. It conferred an adjusted 1.6-fold increased mortality risk. The audience questioned whether AF caused increased late mortality, in which case preventing arrhythmia should produce a mortality benefit, or if postop AF merely reflects an underlying abnormality that increased the risk. That s the key unanswered question, Dr. Ahlsson, a cardiothoracic surgeon at Orebro (Sweden) University, agreed. Research is complicated by a lack of predictors of which CABG patients will get postop AF. Consequences of Postop Atrial Fibrillation At Follow-Up Postop AF (n = 418) All-cause mortality Fatal MI Death due to heart failure Sudden cardiac death 7.4% 3.0% 6.5% 2.6% 2.6% 0.9% No postop AF (n = 1,025) Note: Based on a median of 8 years of follow-up. Source: Dr. Ahlsson 33.3% 19.2% ELSEVIER GLOBAL MEDICAL NEWS
13 SEPTEMBER/OCTOBER 2007 T HORACIC S URGERY N EWS ADULT CARDIAC 13 AHA Guidelines Address Endocarditis Prophylaxis BY WILLIAM E. GOLDEN, M.D., AND ROBERT H. HOPKINS, M.D. T he American Heart Association has issued guidance for the prevention of endocarditis for more than 50 years, and earlier this year issued its first update in a decade. The new guidelines markedly reduce the number of patients who should receive prophylactic antibiotics. Standards for the prevention of endocarditis have been based on expert opinion because the clinical evidence consists mostly of case-control or descriptive studies. Endocarditis results from the interaction of microorganisms with the platelet-rich matrix associated with cellular damage in the endocardium. Most microorganisms in mature vegetations are metabolically inactive and not responsive to antibiotics. Left-sided heart vegetations have a greater density of microorganisms than do rightsided lesions. Viridans streptococci cause more than 50% of community-acquired endocarditis that is not associated with intravenous drug use. This microorganism is part of the normal flora of the skin, the oral cavity, and the respiratory and gastrointestinal systems. Anaerobic bacteria are prominent pathogens in periodontal disease that frequently cause bacteremia, but rarely cause endocarditis. Provision of antibiotics has been shown to be effective in preventing endocarditis in animal experiments. It is estimated that patients per 1 million treated will suffer a fatal anaphylactic reaction after a dose of penicillin. Nearly one-third of these patients had a previous known allergy to penicillin. Similar reactions to cephalosporins are far fewer: one patient per million treated. Fatal reactions to macrolides or clindamycin are extremely rare. Although transient bacteremia is common after procedures involving periodontal tissues, estimates of the frequency of bacteremia after other procedures vary widely. Episodes of bacteremia tend to last less than 10 minutes, with a small fraction of events lasting up to 60 minutes, such as after a tooth extraction. There are no published studies relating endocarditis risk to the duration of bacteremia. Transient bacteremia is also common after daily activities including brushing and flossing teeth, using toothpicks and WaterPiks, and chewing food. The level of bacteremia in daily activities is low, but is similar to the level associated with dental procedures. One study estimates that twice-daily oral hygiene for 1 year exposes a patient to more than 150,000 times the risk of exposure to bacteremia than does a single tooth extraction. Because of the transient bacteremia that occurs as a result of daily activity, patients are at greater cumulative risk of endocarditis on a daily basis than from undergoing dental work, and good oral hygiene may be more protective than periodic antibiotic prophylaxis. The vast majority of infective endocarditis patients did not have a dental procedure within 2 weeks before the onset of symptoms. Because most cases of endocarditis are not associated with dental procedures, antibiotic prophylaxis even if 100% effective would prevent very few cases in the community. The AHA now recommends that endocarditis prophylaxis be reserved for patients with cardiac lesions of such severity that developing endocarditis would increase their risk of death, such as those with prosthetic heart valves, a history of endocarditis, congenital heart disease, and heart transplants with valvulopathy. When used, prophylaxis should target prevention of infections caused by Streptococcus viridans. Those with mitral valve prolapse or coronary stents do not need endocarditis prophylaxis before invasive procedures. Endocarditis prophylaxis is no longer recommended for procedures of the gastrointestinal or genitourinary systems. Prophylaxis requires a single dose of an oral medication. In adults, 2 g of amoxicillin is the preferred agent; in those allergic to penicillin, cephalexin (2 g) or another cephalosporin, clindamycin (600 mg), and macrolides are used. Patients whose penicillin allergy involves anaphylaxis, angioedema, or urticaria should not receive a cephalosporin as alternative therapy. Patients who cannot take oral medications should receive a single parenteral dose of ampicillin (2 g), cefazolin (1 g), or ceftriaxone (1 g). Topical antiseptics are not considered effective in reducing the magnitude and duration of bacteremia associated with dental procedures. The guidelines from the American Heart Association can be found in Circulation 2007 April 19 (Epub doi:10:1161/cir- CULATIONAHA ). DR. GOLDEN is professor of medicine and public health and DR. HOPKINS is program director for the internal medicine/pediatrics combined residency program at the University of Arkansas, Little Rock.
14 14 CARDIOPULMONARY TRANSPLANT T HORACIC S URGERY N EWS SEPTEMBER/OCTOBER 2007 Transplants Elderly from page 1 clude them from receiving a transplant: a body mass index of less than 18 kg/m 2 or greater than 30 kg/m 2, obstructive coronary artery disease, peripheral or cerebral vascular disease, renal insufficiency based on a creatinine clearance rate of less than 50 ml/min, or debilitation. Debilitation was a subjective criterion that gave the UCLA surgeons the flexibility to deny a transplant to any older patient who was judged too ill to undergo transplant surgery, Dr. Bastani said. The average age of the older patients was 66 years, ranging from 65 to 72. The matched, younger patients averaged 58 years old, with a range of The average lung allocation score was about 39 for both groups. Immunosuppression was performed using an interleukin-2 receptor blocker in 67% of the older patients and 24% of younger patients. A more standard immunosuppression regimen of rabbit antithymocyte globulin, a polyclonal mix of antibodies, was used on the remaining 33% of older patients and 76% of younger patients. The interleukin-2 receptor blocker is a more specific and less intense immunosuppression agent that seemed better suited to most of the older patients because of their less robust immune systems, Dr. Bastani said in an interview. Nonstandard donor lungs were used in 46% of the older patients, compared with 28% of younger patients. Among the patients who received nonstandard lungs, 61% of the older patients received a lung from a donor who was older than 55, compared with 29% of younger patients. Single lungs were transplanted into 76% of the older patients (with the other 24% getting a bilateral transplant) and into 16% of the younger patients. Although single-lung transplants were more common among the older patients, the UCLA team did not use any firm age cutoff for determining who could get a bilateral transplant, Dr. Bastani said. During the first 30 days after transplantation, more than 95% of patients survived in both groups. During the first year after transplant, the survival rate was about 80% in the older patients and about 91% in younger patients, a difference that was not statistically significant. The most common cause of death during the first year was bacterial infection, accounting for 75% of the fatalities in older patients and 67% of deaths in younger patients. Survival to 3 years after surgery was about 70% in both groups. When asked to comment on this story, Dr. Robin Pierson, clinical director of Heart and Lung Transplantation and of the Mechanical Circulatory Support Program at the University of Maryland, Baltimore, stated: Chronologic age has shifted from an absolute to a relative contraindication in thoracic organ transplantation. The institution at which the authors of this study are based pioneered alternative donors for alternative heart transplant candidates. As for other organs, this report shows acceptable intermediate-term outcomes can be obtained in recipients up to 72 years of age using a similar strategy. Older candidates received lungs from older donors that might not have been used for younger recipients, in principle expanding the donor pool without disadvantage to traditional candidates. Two issues raised by this report bear particular emphasis. First, it is essential to understand that these candidates were carefully selected, and that the results may not be generalized to older patients with significant comorbidities. The physiological and psychological reserve of the elderly is difficult to quantify, and is severely tested by a complicated postoperative course. It is highly likely that long-term outcomes will prove inferior in this age group, especially as the limits of candidacy are further tested by aggressive programs. Second, the definition of marginal or alternative organ donors is evolving, based on multiple single-center studies and consensus conferences reporting good outcomes using the lungs of these donors for the standard wait list. If some programs would accept these organs for the patients on their standard list, would it be ethical to use the organs for older recipients if a younger patient listed at a nearby program or in an adjacent region is likely to die before another lung becomes available? Fortunately the revised lung allocation scoring system appears to have reduced deaths while waiting, at least among those candidates whose risk of death while waiting is accurately measured by the parameters in the score, Dr. Pierson said. Modeling algorithms for the lung transplant wait list and postoperative outcomes are being developed by the Scientific Registry of Transplant Recipients. It is important that data such as age, along with the many other factors likely to significantly influence overall results, are being considered together as continuous variables. As data accumulate, and these models become refined and are validated, modeling data may be used in real time to inform clinical decisions at the level of the individual donor offered for a particular prospective recipient. Meanwhile, cautious efforts to push the envelope are to be applauded. These efforts offer new hope, with what most of us would judge an acceptable risk/benefit profile, to all patients on the shrinking list of those waiting for a lung. Dr. Pierson is an editorial adviser for THORACIC SURGERY NEWS.
15 SEPTEMBER/OCTOBER 2007 T HORACIC S URGERY N EWS DEVICES & TRIALS 15 Mitral-Valve Replacement A Select Option BY MITCHEL L. ZOLER WASHINGTON Mitral-valve replacement can work as well as mitral-valve repair in a very select group of patients older patients with a more complex valvular pathology though repair is the procedure of choice, in younger patients with posterior prolapse, Dr. A. Marc Gillinov said at the annual meeting of the American Association for Thoracic Surgery. If a valve is repairable, we repair it, regardless of the patient s age, the degree of valve calcification, or the type of prolapse, said Dr. Gillinov, a cardiac surgeon and surgical director of the center for atrial fibrillation at the Cleveland Clinic. But a good replacement is better than a bad repair, he said. The study began by reviewing 3,051 patients who underwent mitral-valve repair and 235 who had mitral-valve replacement for isolated, degenerative mitral disease at the Cleveland Clinic from January 1985 to January The review showed replacement surgery tended to be used on older patients who had left ventricular dysfunction, valve calcification, and an anterior or bileaflet prolapse. Fifteen-year survival rates were about 70% for patients with repair compared with about 35% in patients with replaced valves. To assess survival rates in comparable patients, Dr. Gillinov and his associates used propensity matching to identify 195 patients who underwent valve repair whose clinical, demographic, and valve characteristics at the time of repair closely matched a paired patient from the replacement group. The 15-year survival rate in these 195 matched pairs of patients was very similar in each treatment group, about 40%. Survival was also similar to what could be expected for similar patients who did not undergo mitral-valve surgery The message from these results is that for the approximately 10% of patients whose valve disease is complicated and who have comorbidities, mitral-valve replacement doesn t appear to compromise survival, commented Dr. Bruce W. Lytle, chairman of thoracic and cardiovascular surgery at the Cleveland Clinic. INDEX OF ADVERTISERS Applied Fiberoptics Corporate 13 Bayer HealthCare Pharmaceuticals Corporate 24 ETHICON ENDO-SURGERY, Inc. Endopath 45 5 General Scientific Corporation SurgiTel 4 Kimberly-Clark Worldwide, Inc. InteguSeal 9 PDL BioPharma, Inc. Cardene I.V. 7-8
16 Congratulations! 2007 Bayer Fellowship Recipients Jochen D. Muehlschlegel, MD Fellow in Cardiac Anesthesia Department of Anesthesiology Perioperative and Pain Medicine Harvard Medical School Brigham and Women's Hospital Project: Genetic variation in platelet glycoproteins and perioperative myocardial infarction Mentor: Simon C. Body, MBChB, MPH Patrick S. Wolf, MD Resident in General Surgery Department of Surgery University of Washington Project: Inflammatory signaling in lung ischemia reperfusion injury Mentor: Michael Mulligan, MD Sitaram M. Emani, MD Resident in Cardiac Surgery Department of Cardiovascular Surgery Children's Hospital, Boston Project: Characterization of transforming growth factor-beta signaling and extracellular matrix remodeling in tissue engineered constructs subjected to mechanical shear stress Mentor: John E. Mayer, MD 2006 Bayer Fellowship Extension Juan Nicolas Pulido, MD Fellow in Cardiovascular Anesthesiology Department of Anesthesiology Mayo Clinic College of Medicine Project: Exposure to low dose carbon monoxide and regulation of the inflammatory response to cardiopulmonary bypass in a rat model Mentor: Mark H. Ereth, MD For more information visit or call Printed in the USA 2007 Bayer Pharmaceuticals Corporation TT