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P E D I A T R I C
C A R D I O L O G Y                                                                           T O D A Y
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The editorial board...
PEDIATRIC CARDIOLOGY TODAY                                                                                  MARCH 2005    ...
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medical knowledgeba...
PEDIATRIC CARDIOLOGY TODAY                                                                                   MARCH 2005   ...
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  PFM DEVICE C LOSE...
PEDIATRIC CARDIOLOGY TODAY                                                                                               M...
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had the smalle...
PEDIATRIC CARDIOLOGY TODAY                                                                                     MARCH 2005 ...
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PEDIATRIC CARDIOLOGY TODAY                                                                                    MARCH 2005  ...
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PEDIATRIC CARDIOLOGY TODAY                                                                                       MARCH 200...
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PEDIATRIC CARDIOLOGY TODAY                                                                             MARCH 2005         ...
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  1. 1. P E D I A T R I C C A R D I O L O G Y T O D A Y R E L I A B L E I N F O R M A T I O N I N P E D I A T R I C C A R D I O L O G Y VOLUME 3, ISSUE 3 WWW.PEDIATRICCARDIOLOGYTODAY.COM MARCH 2005 P EDIATRIC CARDIOLOGY T ODAY B ECOMES C ONGENITAL INSIDE THIS ISSUE C ARDIOLOGY T ODAY Pediatric Cardiology 1 letter relating to interests of an international Today Becomes W hat’s in a name? Just a few words but a audience in addition to an expanded North Congenital Cardiology lot of meaning! American audience. In the United States Today and Canada, and a few other countries, a As of the April issue, Pediatric Cardiology new specialty focusing solely on the adult Today will become Congenital Cardiology age patient with congenital heart disease An Update on 3 Today. The name change accompanies an has arisen. The newsletter seeks to include Information expansion of the newsletter from a print these physicians who specialize in adult Technology in Cardiac publication distributed only in North America congenital heart disease among its reader- Medicine to an international print and electronic publi- ship. by Geoffrey L. Bird, MD cation. There will be two editions each CONGENITAL month. North American readers will con- Pfm Device Closes 6 tinue to receive the monthly printed newslet- Perimembranous VSDs ter in their regular mail boxes. International by John W. Moore, MD readers will receive the Table of Contents of CARDIOLOGY TODAY the newsletter at their work or personal Transcatheter Cardiac 9 email accounts from which they can then go Figure 1. The new name and logo starting with the Valve Implantation to the specific issue, and read it electroni- April 2005 issue. by Carlos E. Ruiz, MD cally in a PDF file. In addition, the scope and focus of the publication will shift from A sampling of readers and Board Members issues primarily of interest to North Ameri- of Pediatric Cardiology Today supports the DEPARTMENTS cans, to issues of interest to the wider inter- name change: Michael Slack, MD of Chil- national audience as well as an expanded dren’s National Medical Center in W ash- April Conference Focus 8 group of North American readers. W hile ington, DC likes the idea because he says - 2nd Annual Symposium most of the content will be shared between many “adult” cardiologists refer their adult patients with congenital heart disease to on New Interventions in him. Gil W ernovsky, MD of The Children’s Transcatheter Valve Hospital of Philadelphia stated that he was Techniques “As of the April issue, contemplating changing his title to Pediatric Cardiology Today “Congenital Cardiologist.” And Ziyad Hijazi, Medical News 15 will become MD, MPH actually suggested the name change. We suspect that most North Ameri- Congenital Cardiology Today.“ can readers will understand and support the Editorial Comment 19 change. At the same time, congenital cardiology is the North American and International ver- Medical Conferences 19 sions, each will have selected news and more recognizable and acceptable to many information with a regional significance. of our international colleagues. After all, what’s the difference between a 15 year old In much of the world, patients of all ages and a 30 year old with Tricuspid Atresia? with congenital heart disease are treated by Congenital Cardiology Today will deal with PEDIATRIC CARDIOLOGY TODAY a single cardiologist. Most patients are chil- the issues of both patients all around the dren, however largely because of the suc- world. 9008 Copenhaver Drive, Ste. M Potomac, MD 20854 USA cess of modern treatment modalities, an www.PediatricCardiologyToday.com increasing percentage are adults. This is also true to a considerable extent in U.S., “The name change signifies © 2005 by Pediatric Cardiology Today Canada and other countries, where the phy- (ISSN 1551-4439). Published monthly. sicians are designated “pediatric cardiolo- the expanding scope of the All rights reserved. Statements or opin- ions expressed in Pediatric Cardiology gists.” newsletter to include issues of Today reflect the views of the authors The name change signifies the expanding adults as well as children with and are not necessarily the views of scope of the newsletter to include issues of congenital heart disease.“ Pediatric Cardiology Today. adults as well as children with congenital heart disease, and the widening focus of the
  2. 2. PAGE 2 MARCH 2005 PEDIATRIC CARDIOLOGY TODAY The editorial board has expanded to • Yun-Ching Fu, MD • Shakeel A. Qureshi, MD include physicians from all parts of the Taichung Veterans General Guy's Hospital world including Argentina, Australia, Hospital London, United Kingdom Brazil, Brunei, Canada, Chile, Ger- Taichung, Taiwan many, India, Japan, Lebanon, Malay- • Andrew Redington, MD sia, Mexico, Saudi Arabia, Taiwan, • Felipe Heusser, MD The Hospital for Sick Children United Kingdom, and the United P. Universidad Católica de Chile Toronto, Canada States. Below is the expanded list of School of Medicine editorial board members for Congenital Santiago, Chile • Carlos E. Ruiz, MD, PhD Cardiology Today (in alphabetical or- University of Illinois at Chicago der): • Ziyad M. Hijazi, MD, MPH Chicago, USA The University of Chicago Heart • Teiji Akagi, MD Center • Girish S. Shirali, MD, MBBS Cardiac Care Unit Chicago, USA Medical University of South Okayama University Carolina Okayama, Japan • Ralf Holzer, MD Charleston, USA Royal Liverpool Children's NHS • Zohair Al Halees, MD Trust • Horst Sievert, MD King Faisal Heart Institute Liverpool, United Kingdom CardioVascular Center Frankfurt King Faisal Specialist Hospital & Frankfurt, Germany Research Centre • R. Krishna Kumar, MD, DM, MBBS Riyadh, Saudi Arabia Amrita Institute of Medical • Hideshi Tomita, MD, PhD Sciences and Research Centre Sapporo Medical University School • Mazeni Alwi, MD Kochi, India of Medicine Institut Jantung Negara Sapporo, Japan National Heart Institute • Gerald Ross Marx, MD Kuala Lumpur, Malaysia Boston Children’s Hospital and • William C. L. Yip, MD Harvard Medical School Gleneagles JPMC Cardiac Centre • Felix Berger, MD Boston, USA Brunei, Darussalam German Heart Institute Berlin, Germany • Tarek S. Momenah, MD, MBBS • Gil Wernovsky, MD Prince Sultan Cardiac Center The Cardiac Center at The • Fadi Bitar, MD Riyadh, Saudi Arabia Children's Hospital of Philadelphia American University of Beirut Philadelphia, USA Beirut, Lebanon • John W. Moore, MD, MPH Mattel Children’s Hospital at UCLA • Carlos Zabal, MD • Philipp Bonhoeffer, MD Los Angeles, USA Ignacio Chavez National Institute Great Ormond Street Hospital for of Cardiology Children, NHS Trust • Toshio Nakanishi, MD, PhD Mexico City, Mexico London, United Kingdom Heart Institute of Japan Tokyo Women's Medical Center • Anthony C. Chang, MD, MBA Tokyo, Japan To Contact an Editorial Board Member Texas Children's Hospital Houston, USA • Carlos A. C. Pedra, MD Send your e-mail to: Instituto Dante Pazzanese de • Bharat Dalvi, MD, MBBS, DM Cardiologia NAME@CongenitalCardiologyToday.com Glenmark Cardiac Centre São Paulo, Brazil Dr. Balabhai Nanavati Hospital Place the Board Member’s last name and Breach Candy Hospital and • James C. Perry, MD before the @. For example, to send an email Research Centre Yale University School of Medicine to Dr. Moore, you would send it to Bombay, India New Haven, USA Moore@CongenitalCardiologyToday.com • Horacio Faella, MD • Daniel J. Penny, MD Your email will be forwarded to the Garrahan Children's Hospital Royal Children's Hospital appropriate person Buenos Aires, Argentina Melbourne, Australia 28th Annual Scientific Sessions and Melvin P. Judkins Cardiac Imaging Symposium May 4-7, 2005, Ponte Vedra Beach, Florida The Society for Cardiovascular Angiography and Interventions www.scai.org © Copyright 2005, Pediatric Cardiology Today. All rights reserved www.Ped iatricCard iolog y Today .com
  3. 3. PEDIATRIC CARDIOLOGY TODAY MARCH 2005 PAGE 3 A N U P DAT E O N I N F O R M AT I O N T E C H N O LO G Y I N C A R D I A C MEDICINE By Geoffrey L. Bird, MD It’s a basis for physicians and other clinicians often being maligned as tech- nophobes. But, how could you look at “We don’t fear the Does the fact that I own a 40GB iPod the daily life of a laparoscopic surgeon, technology; we love the mean that I shouldn’t buy one of the cardiac perfusionist, or cardiac inten- technology. We just don’t new iPod Shuffles? Don’t I owe it to my sive care nurse and accuse clinicians want it to kill our 5 year old son to boost his chances at of being technophobes? patients.” getting into college with an iMac? It isn’t fear that drives clinician restraint These and other “important” questions with technology. It’s the lives of our are the ones I’m pondering from to- Palm operating system, whereas the patients. When the new suite of PDAs day’s USA Today in my hotel room in 10% remainder worked with Microsoft’s at the car dealership goes wrong, the Houston. The reason I’m here is kind of Pocket PC operating system. Resi- sales staff might have to revert back to neat, but more about that later. First I dents used the handhelds mostly in paper day-runners and contact lists. wanted to discuss an approach to an- hospital settings for direct patient care, The biggest cost might be that a car other hot topic in medical information like drug information programs, medi- goes unsold. When the new PACS an- technology circles – the hand held cal references, and medical calcula- giography system of a cardiology de- computer. Admittedly, I am a gadget tors. Attending physicians used them partment goes down from an unfore- lover. I’m the kind of guy who doesn’t more in administrative settings and for seen bug, delays in interpretation and get upset if his PDA gets dropped or scheduling/calendar applications. diagnosis could cost lives. We clini- broken. Why? It’s the opportunity to get cians know this, and we’ve known it for There have been several other survey a new one! My geekness is all well and years. That’s what makes us move so based reports of handheld usage pat- good on a personal level, but I think slow in the minds of business and in- terns in medicine. There results are there’s an important lesson to be formation technology (IT) intelligentsia. pretty much in line with what you’d find learned in approaching technology as a We don’t fear the technology; we love walking down the hallway of any hospi- healthcare provider. the technology. We just don’t want it to tal. Handhelds have arrived; they’re Medicine is still falling in love with the kill our patients. being used by many clinicians in many PDA, long after business has decided different productive ways, but many PDAs are coming into vogue that it needs a different solution to its clinicians are still getting along fine problems. But, for technology in gen- Literature describes that PDA use in without them. eral, that’s a tired tale. Many have real- medicine has evolved over time. That Why isn’t their use more universal and ized for some time that information use has matured into a tighter and widespread? It’s been nearly 10 years technology trends show up earlier in more seamless assimilation. When since the earliest descriptions of hand- the business world than in medicine. McLeod et al. 1 sent surveys to the 867 helds in medicine were published in the physician members of the Mayo Paleozoic era of the Apple Newton in Clinic’s Department of Internal Medi- 1995(2). One of the unfortunate facts “It isn’t fear that drives cine in Rochester, Minnesota, they about handhelds is that there have clinician restraint with received 473 responses. 46% of the been few, if any, outcome studies con- responders reported use of a PDA, with technology. It’s the lives cerning their introduction or ongoing extremes ranging from 68% of trainee of our patients.“ use. residents to 37% for attendings. Ninety percent chose handhelds based on the Some of the people behind Isabel, a www.Ped iatricCard iolog y Today .com © Copyright 2005, Pediatric Cardiology Today. All rights reserved
  4. 4. PAGE 4 MARCH 2005 PEDIATRIC CARDIOLOGY TODAY medical knowledgebase and decision ECG images of chest pain patients to in which handhelds and other technol- suppor t s y s t em in the UK the PDAs and smartphones of cardiolo- ogy implementations might contribute (www.isabel.org.uk), organized a con- gists at receiving hospitals. The result? to medical error. Thankfully, this issue version of access methodology from Certain patients with particular sub- is being looked into, addressed, and desktop to handheld computers with types of myocardial infarction are being described in the literature. 7 Ash et al. wireless Internet access. After enabling diverted from wasted minutes being have taken things a long way toward a access via wireless Internet handhelds, triaged in the ED directly to a fully better understanding of the epidemiol- the frequency of Isabel queries among prepped and waiting cardiac catheteri- ogy of technology-induced medical house staff at four London hospital zation lab for intervention. error. units increased by over 400%. 3 What Each of these PDA interventions had a As for failed implementations, there’s they and others have yet to show is clear and present effect on a surrogate not just the blistering pace of techno- that their patients fared better and/or marker for patient outcome; know- logical progress to blame. Rather, in left hospital sooner. That being said, it ledgebase consultation, error fre- some cases it seems that certain hand- is probably a good thing that clinicians quency, and time delay to definitive held proponents, largely trade writers checked into their available knowledge- therapy. Until more outcome studies and technology vendors, have almost base more frequently. are described, we’ll take these findings magical thinking regarding the capabili- In this era of increased attention to the for the positive indicators that they are. ties of handhelds in medicine. Hand- prevalence of medical errors, it’s al- helds are very good at storing, trans- most become assumed that the ab- “Information technology is mitting, and recalling units of informa- sence of error implies the presence of seen as one of the tion that could fit on an index card. As quality. While there’s reason to debate such, they fit very well into certain cornerstones of patient that the two are so closely related, medical work styles, i.e. that of a medi- Grasso et al. 4 used a handheld solution safety, error reduction, cal trainee. If, for hundreds of years, to decrease the rate of medication tran- and improved outcomes. the job of a medical trainee has in- scription errors on discharge forms What is less clear are the volved “index cards,” it stands to rea- from 22% to 8% in back to back four ways in which handhelds son that handhelds can probably help month periods. As mentioned above, to do the job better. while there was no follow-on discus- and other technology implementations might Handhelds, however, do not provide sion about improved patient outcomes, every solution for medical workflow this powerful reduction of error is abso- contribute to medical inefficiencies and care deficiencies. lutely a good thing. While their impres- error.“ The cardiac ICU clinician that needs to sion was that the “PDA was inexpen- view a large amount of simultaneous sive and simple to use,”(p1326) the At that same time, we have to remem- graphical waveform data might do bet- implementation and change was clearly ber that no one is publishing results of ter with a wireless tablet PC or laptop, driven by motivated investigators and a their handheld interventions that went rather than a handheld computer. The significant period of training time for wrong. How many old Palm cardiologist in private practice that the institution’s staff. “Professionals” and “Palm VII’s” are wants to view their patient’s an- sitting unused in desks? They were, no In the world of cardiology, evidence of giograms and radiographs would cur- doubt, bought or donated with noble a PDA’s role in care improvement are rently be better off viewing these im- intentions, but the pace of computer slowly coming to light. Pettis, et al. 5 ages on a device that’s just plain big- technical progress is far greater than and Leibrandt, et al. 6 showed that car- ger than a handheld. In contrast, the our own pace at assimilating new tech- diologists were as facile reading elec- business people and general public nology into clinical practice. trocardiograms on the LCD screens of that are making cell phones and smart- PDAs and cellular telephones, as they Information technology is seen as one phones fly off the shelves, need less were on paper. The natural subsequent of the cornerstones of patient safety, screen space than many clinicians try- effect on care is already taking place. error reduction, and improved out- ing to make decision on graphical data. Paramedics in the field are transmitting comes. What is less clear are the ways Fifth International Pediatric Cardiovascular Symposium: Management of Complex Congenital Heart Disease From Infancy to Adulthood The Ritz-Carlton, Amelia Island, June 23-26, 2005 w ww . ch o a. o rg/ fo rp ro fession al s/ cme or call Nancy Richardson 404-785-7843 or Kathy Murphy 404-785-6480 © Copyright 2005, Pediatric Cardiology Today. All rights reserved www.Ped iatricCard iolog y Today .com
  5. 5. PEDIATRIC CARDIOLOGY TODAY MARCH 2005 PAGE 5 for us, good for the vendor (which is 6. Leibrandt PN, Bell SJ, Savona MR also good for us), but, most impor- et al. Validation of cardiologists' deci- “But neither we, nor our tantly, it’ll be good for our patients… sions to initiate reperfusion therapy for patients, will be better off, Please stay tuned! acute myocardial infarction with elec- if we try to justify an trocardiograms viewed on liquid crystal The reader is referred to Fischer et al. 8 investment in the expense for a comprehensive and well-written displays of cellular telephones. Am and effort of bringing Heart J 2000; 140: 747-752. review and compendium of resources PDAs further into our concerning handheld computers in 7. Ash JS, Berg M, Coiera E. Some practices with the “Wow! medicine. unintended consequences of informa- tion technology in health care: the na- Factor” and “Think of When Geoffrey Bird isn’t busy trying to ture of patient care information system the potentials!” rationalize the purchase of a new elec- related errors. J Am Med Inform Assoc tronic gadget, he continues in his role 2004; as one of the staff cardiac intensivists In the medical world, PDAs are not at The Children’s Hospital of Philadel- 8. Fischer S, Stewart TE, Mehta S, dead. With lots of unsuccessful fits and phia. Comments, scathing critique, and Wax R, Lapinsky SE. Handheld com- starts hiding in the closet, handheld unfettered praise are all warmly re- puting in medicine. J Am Med Inform computers have finally gained enough ceived at bird@email.chop.edu. Assoc 2003; 10: 139-149. ground in medicine to start showing up Reference List For comments to this article, send email to: more frequently in the literature. There, MARGLB@PediatricCardiologyToday.com they are clearly shown as having an 1. McLeod TG, Ebbert JO, Lymp JF. important role for aspects of our medi- ~PCT~ Survey assessment of personal digital cal work for the near future. But, hand- assistant use among trainees and at- helds cannot do everything. If we un- tending physicians. J Am Med Inform derstand what they are, and what they Assoc 2003; 10: 605-607. are not, we’ll be better off. If we under- stand and share descriptions of how 2. Labkoff SE, Shah S, Bormel J, Yee they are successfully (and unsuccess- Y, Greenes RA. The Constellation pro- fully) incorporated into the jobs we do, ject: experience and evaluation of per- we’ll be better off. sonal digital assistants in the clinical Geoffrey L. Bird, MD, FAAP environment. Proc Annu Symp Comput Staff Cardiac Intensivist But neither we, nor our patients, will be Appl Med Care 1995; 678-682. Assistant Professor of Anesthesiology better off, if we try to justify an invest- 3. Ramnarayan P. Personal communi- & Pediatrics ment in the expense and effort of bring- University of Pennsylvania ing PDAs further into our practices with cation: Isabel User Survey May 2003.2004. The Children's Hospital of Philadelphia the “Wow! Factor” and “Think of the Philadelphia, PA potentials!” 4. Grasso BC, Genest R, Yung K, Ar- nold C. Reducing errors in discharge b ir d @e ma il. c h o p . e d u Now what about the Houston hotel room? I’ll give you a hint, but then medication lists by using personal digi- you’ll have to come back to a future tal assistants. Psychiatr Serv 2002; 53: This article is an expansion of one written issue of this journal (if the editors will 1325-1326. by Dr. Bird for the American Heart Associa- have me!). A group of pediatric cardio- tion’s (AHA) Spring 2004 edition of the 5. Pettis KS, Savona MR, Leibrandt Council Connections Newsletter– A Quar- vascular professionals are trying a new PN et al. Evaluation of the efficacy of terly Communication of the AHA/ASA, Vol. approach for getting more of what we hand-held computer screens for cardi- 2, No. 1, "Whither the hype: An update on want from one of our software vendors. ologists' interpretation of 12-lead elec- personal digital assistants in cardiac medi- It starts with “C” and ends with trocardiograms. Am Heart J 1999; 138: cine." For more information: “ooperation,” and the multi-institutional 765-770. www.americanheart.org involvement looks like it could be good www.Ped iatricCard iolog y Today .com © Copyright 2005, Pediatric Cardiology Today. All rights reserved
  6. 6. PAGE 6 MARCH 2005 PEDIATRIC CARDIOLOGY TODAY PFM DEVICE C LOSES PERI ME MBRANOUS V S DS By John W. Moore, MD Dr. Le has a track record in closing VSDs using the pfm Nit-Occlud device. The Nit-Occlud device is a nitinol coil Closure of the perimembranous VSD is with a cone-in-cone configuration, de- the latest challenge for transcatheter signed for PDA closure. It is available devices. To date, the Amplatzer Pe- in most of the world without restric- r i m em b r a n o u s VSD O ccl uder tions, and it is currently finishing a (Amplatzer Medical Corporation, Phase 2 FDA clinical trial in the United Golden Valley, MN) has been the only States. Dr. Le has performed closure device available. Recent events in of perimembranous and muscular Brazil appear to have opened up the VSDs using the Nit-Occlud coil with field. surprisingly good results: achieving In Rio de Janeiro, on January 15th and greater than 90% complete closure in 16th Dr. Trong Phi-Le and Dr. Luis muscular VSDs, and almost 80% in Figure 2. Nit-Occlud Perimembraneous VSD Carlos Simoes implanted some of the perimembranous defects by 6 months Occluder . Photograph courtesy of Dr. Le. first pfm (Productke fur die Medicine, after implant. Furthermore, in more Cologne, Germany) devices designed than 40 patients there have been no coils of the device, much like the syn- to close perimembranous VSDs. In Rio deaths and no major complications. thetic fibers in a standard Cook Gian- de Janeiro, six patients were catheter- Dr. Le expects that the modified Nit- turco coil. Several prototype devices ized. Their defects were all restrictive have been built, the largest being the but hemodynamically significant. The 14 x 8 device. (The device nomencla- defects ranged from 4 mm to 8 mm “Certainly, these ture refers to the sizes of the largest minimum diameter, most with some anecdotal results look diameter left ventricular coil, followed aneurysm formation. None had aortic promising. We should by the largest diameter right ventricular cusp prolapse or aortic insufficiency. look forward to Dr. Le’s coil.) The 14 x 8 device has a maxi- The distance from the superior rim of mum left ventricular coil diameter of 14 data from the first series mm and a maximum right ventricular the defects to the aortic valve annulus ranged from 2 to 4 mm. These VSDs of pfm Nit-Occlud VSD coil diameter of 8 mm. were similar to those reported in Am- device implants.” Drs. Le and Simoes implanted the Nit- platzer closures. 1-3 Occlud VSD devices using techniques Occlud device will perform better. similar to those employed for the Am- The Nit-Occlud VDS device, like the platzer device. Typically, the VSD was PDA device, is made of nitinol coils assessed by transesophageal echocar- and has a cone-in-cone configuration. diography and long axis oblique an- The device has been modified by add- giography. The defect was crossed ing additional larger, reinforced coil retrograde using a Judkins right coro- loops on both the left ventricular and nary catheter and a floppy wire. The the right ventricular ends of the coil. wire was advanced into the pulmonary Perhaps more importantly, polyester artery, with care to avoid the moderator fibers have been added to the left ven- band and the tricuspid apparatus. The Figure 1. Nit-Occlud PDA Occluder. Photo- tricular cone. The fibers are placed wire tip was snared in the pulmonary graph courtesy of Dr. Le. between the tightly spaced primary artery by a loop snare introduced in the CHINA MEDBOOK The authoritative guide on medical devices and suppliers in China Phone: 800-571-6117 Fax: 800-571-6127 w w w .l if e sc ie nc e sp ubl is hi ng .c o m © Copyright 2005, Pediatric Cardiology Today. All rights reserved www.Ped iatricCard iolog y Today .com
  7. 7. PEDIATRIC CARDIOLOGY TODAY MARCH 2005 PAGE 7 A B C D Figure 3 (A-D). (A) VSD prior to device closure; (B) Nit-Occluder device in VSD prior to release; (C) Nit-Occluder device in VSD after release; (D) Nit-Occluder device does not interfere with aortic valve function. Courtesy of Dr. Simones. femoral vein. The wire end was exter- passed through the VSD and was com- device is developed to anchor the de- nalized and a “rail” established. The fortably into the ascending aorta. The vice. This is done carefully in order to Judkins catheter was advanced Judkins catheter was removed and a avoid entrapping tricuspid valve struc- through the VSD along the rail into the pigtail catheter was advanced from the tures. Angiography and echocardi- inferior vena cava. A 7 French long femoral artery along the wire until it ography are employed to verify good sheath (Cook Flexor or Cordis Brite met the dilator. Subsequently, the dila- device position, and the device is de- tor was removed and the pigtail cathe- tached. ter was advanced into the sheath to the Of the six procedures performed in Rio level of the hepatic portion of the IVC, de Janeiro, five were successful with 4 this maneuver to prevent sheath kink- patients achieving total occlusion prior ing. The Nit-Occlud delivery catheter to departing from the catheterization was introduced into the sheath and laboratory. One patient had good de- advanced to the tip of the pigtail cathe- vice position, but had a small amount of ter. The delivery catheter was further leaking at the time of the last angiogram. advanced into the ascending aorta as The unsuccessful patient interestingly the pigtail catheter was withdrawn from the sheath. The delivery catheter was extended outside the long sheath, and the distal cone of the device was formed by pushing the coil outside the Figure 4. Drs. Simoes and Le confer prior to catheter. The distal cone was gently VSD Closure. pulled to the level of the aortic sinuses and allowed to fall through the aortic Tip) was introduced into the femoral valve into the left ventricular outflow vein, and advanced on the rail until the tract. Once in the outflow tract, the dilator “docked” with the tip of the Jud- distal coil cone was gently pulled into kins catheter introduced in the femoral the VSD, guided by echocardiography artery. Clamps were attached to both and fluoroscopy. The largest one or ends of the wire securing a tight dock- two loops remain opposed to the left ing of dilator and Judkins catheter. ventricular rims of the defect. The re- Figure 5. Dr. Le and Dr. Simoes perform a The sheath was advanced as the Jud- mainder of the coil cone is within the VSD Closure. kins was withdrawn, until the sheath defect. Finally, the reverse cone of the www.Ped iatricCard iolog y Today .com © Copyright 2005, Pediatric Cardiology Today. All rights reserved
  8. 8. PAGE 8 MARCH 2005 PEDIATRIC CARDIOLOGY TODAY had the smallest defect (4 mm) and the 3. Pedra CA, Pedra SR, Esteves CA, least aortic side rim (about 2 mm). Dr. Pontes SC, Braga SL, Arrieta SR, APRIL CONFERENCE FOCUS Le felt that an 8 mm maximum aortic Santana MV, Fontes VF, Masura J. Per- coil diameter was appropriate. The cutaneous closure of perimembranous 2nd Annual Symposium on New smallest available device had a 10 mm ventricular septal defects with the Interventions in Transcatheter coil diameter. Closure with a smaller Amplatzer device: technical and morpho- Valve Techniques Nit-Occlud PDA device was attempted, logical considerations. Catheter Cardio- April 28-29, 2005 Hyatt Regency Chicago, Chicago, IL without success. This coil was re- vasc Interv 2004;61:403-410. www.tvsymposium.com moved. There were no complications For comments to this article, send email to: in these six patients. Early follow up This 2nd symposium has been created by MARJWM@PediatricCardiologyToday.com shows that all five with device implants course organizers, Carlos Ruiz, MD, PhD; ~PCT~ Philipp Bonhoeffer MD; Carlos Duran, MD, were totally closed at their first follow PhD; and Sir Magdi Yacoub, MD. In addi- up echocardiograms. tion, faculty members include Drs. Mark Galantowicz, of Columbus, USA; Ziyad Hi- Dr. Le later traveled on to Puerto Ale- jazi, of Chicago, USA; Peter Kleine, Frank- gre and Sao Paulo, and the Rio de furt, Germany; Andrew Redington, Toronto, Janeiro experience was repeated in the Canada; Jose Antonio Condado, Caracas, labs of Dr. Raul Rossi Filho and Dr. Venezuela; Alain Cribier, Rouen, France; Carlos Pedra. From there he traveled Jacques Seguin, Créteil, France; Patrick Serruys, Rotterdam, Netherlands; Steven to Vietnam, presumable to implant ad- John W. Moore, MD, MPH, FACC Oesterle, Minneapolis, USA; Robert ditional devices. Director of the Pediatric Cardiac Lederman, Washington, DC USA; Jan Certainly, these anecdotal results look Catheterization Laboratory Harnek, Lund, Sweden; Howard Herrmann, Mattel Children’s Hospital at UCLA Philadelphia, USA; and Martin Elliott, promising. We should look forward to London, UK to name a few. Dr. Le’s data from the first series of jwmoore@mednet.ucla.edu pfm Nit-Occlud VSD device implants. The symposium will be broken into major sections: Many of our colleagues will get to ob- Get A FREE GOOGLE GMAIL ACCOUNT serve the procedure soon because Dr. • BACK TO SCHOOL (Chairs: Drs. P. Carlos Pedra is planning to perform a Pediatric Cardiology Today is offering 500 Bonhoeffer & M. Yacoub) live case demonstration at PICS in free GMAIL accounts to subscribers compli- Buenos Aires this September. Stay ments of Google. To get your own account • IMAGING (Chairs: Drs. C. Ruiz & P. send an email to: Serruys) tuned! References: rkoulbanis@gmail.com • TRANSCATHETER TECHNOLOGIES Include your name, title, organization, (Chairs: Drs. C. Duran & Z. Hijazi) 1. Hijazi ZM, Hakim F, Haweleh AA, Ma- address, phone, and email. Offer is only dani A, Tarawna W, Hiari A, Cao QL. available to the first 500 requests. • THE SURGEON’S PERSPECTIVE (Chairs: Drs. V. Fuster & M. Leon) Catheter closure of perimembranous ventricular septal defects using the new Ask the Editorial Board • CROSS FIRE SESSION (Chairs: Drs. Amplatzer membranous VSD occluder: P. McCarthy & C. Ruiz) initial clinical experience. Catheter Car- diovasc Interv 2002;56:508-515. Do you have a question about a pro- • WHAT HAVE WE LEARNED FROM cedure, technology or product that you THE COMPLICATIONS? (Chairs: Drs. 2. Thanopoulos BD, Tsaousis GS, Kara- would like to ask the Editorial Board’s A. Cribier & J. Cox) nasios E, Eleftherakis NG, Paphitis C. opinion? e-mail your question to: • OVERCOMING ROADBLOCKS Transcatheter closure of perimembra- ASK@PediatricCardiologyToday.com (Chairs: Drs. A. Redington & W. O’Neill) nous ventricular septal defects with the Amplatzer asymmetric ventricular septal Selected questions and answers may • STATE OF THE ART SURGICAL defect occluder: preliminary experience be published in upcoming issues. VALVE PROCEDURES (Chairs: Drs. P. Names will be withheld upon request. Bonhoeffer & C Duran) in children. Heart 2003;89:918-922. Do You Want to Recruit a Pediatric Cardiologist? Advertise in the only monthly publication totally dedicated to pediatric cardiology. For more information: Jobs@PediatricCardiologyToday.com © Copyright 2005, Pediatric Cardiology Today. All rights reserved www.Ped iatricCard iolog y Today .com
  9. 9. PEDIATRIC CARDIOLOGY TODAY MARCH 2005 PAGE 9 T R A N S C AT H E T E R C A R D I A C V A LV E I M P L A N TAT I O N valve surgery, “…one should not have the past. They all experienced a signifi- By Carlos E. Ruiz, MD been totally discouraged by the failures, cant decrease in the existing transvalvu- but rather encouraged by the limited suc- lar gradient from 39 mmHg to 21 mmHg cess.” We must not forget those early (p<0.001). However, the most impres- Introduction results of prosthetic valve implantation sive parameter is the resolution of the The management of valvular heart dis- and objectively keep it in mind when we pulmonary insufficiency causing an im- ease remains one of the major chal- are ready to evaluate today’s results with mediate decrease in the right ventricular lenges to contemporary medicine. It the new transcatheter technologies. end-diastolic volume, with a concomitant involves the choice of the most appropri- increase in the left ventricular end- Transcatheter Pulmonary Valve ate medical regimens, the right timing for diastolic volume MRI. These immediate Implantation intervening, choosing the right procedure hemodynamic changes translated into a and certainly the most appropriate pros- The first transcatheter cardiac valve im- significant improvement of the patient thesis, when a new valve implant is con- planted in humans was performed by Dr. metabolic exercise testing, increasing the sidered. Philipp Bonhoeffer and was reported in peak oxygen consumption from 24.4+1.5 Lancet October 21, 2000.2 Bonhoeffer ml/kg/min to 26.3+1.6 ml/kg/min Operative cardiac valve intervention is used a clinically available preserved bo- (p=0.009). The median age is 16 (9-44) actually almost a century old and was vine jugular vein valve sutured to a Nu- years and the median number of previ- first pioneered by Theodore Tuffier Med CP stent and crimped on a balloon ous cardiac surgeries was three.2,3 (1857-1929) who successfully attempted catheter (Figure 1). the first operative treatment of a patient There have been few device failures, with aortic stenosis on July 13, 1912 with In the past 5 years he has implanted which include the so-called “Hammock a finger-dilatation. However, the first more than 81 valves in 75 patients with Effect” that has been resolved by re- human implant of a prosthetic ball-valve 98% success rate. The majority of pa- engineering the suture of the valve on was done on September 11, 1952 by tients were post repair of tetralogy of the stent and also there have been sev- Charles A. Hufnagel (1916-1989) in a Fallot, pulmonary atresia-VSD, d-TGA, eral stent fractures. patient with severe aortic insufficiency truncus arteriosus, s/p Ross procedure Procedural complications occurred in that was implanted in the descending etc. and the great majority have had four patients and were life-threatening in aorta. The first successful aortic valve more than one thoracotomy performed in two. Freedom from surgical re- replacement in the subcoronary position was performed by Dr. Dwight Harken and colleagues1 and caged ball valve was also used. The first conference on pros- thetic heart valves was held in Septem- ber of 1960. Since then a periodic as- sessment of the many undertakings to develop valve substitutes and their ex- perimental an clinical evaluation have made possible a tremendous advance in this field. This progress has not been easy or free of serious disappointments. The mortality in the early experiments was extremely high, greater than 40%. Yet, as was prophetically pointed out by Dr. K.A. Merendino, another pioneer in Figure 1. Bonhoeffer ’s pulmonary valve. Courtesy of Dr. P. Bonhoeffer. www.Ped iatricCard iolog y Today .com © Copyright 2005, Pediatric Cardiology Today. All rights reserved
  10. 10. PAGE 10 MARCH 2005 PEDIATRIC CARDIOLOGY TODAY valve location does not have the same from the Dotter Interventional Institute of adjacent vulnerable structures as the the University of Oregon. This valve util- aortic valve and therefore there is no risk izes a biomaterial called SIS, which is of device failure that can be catastrophic. derived from the small intestinal Finally, all these patients are destined to (jejunum) submucosa of the pig. This undergo re-operations, thus making it biomaterial is basically an acellular ma- easier to justify this approach to minimize trix mostly composed of type-I and some the number of thoracotomies. type III and IV collagen that contains other extracellular matrix molecules such There are other transcatheter cardiac as fibronectin, hyaluronic acid, chondro- valve prosthesis that are currently in the itin sulfate A and B, heparin, heparan animal investigational phase. Perhaps, sulfate and some growth factors such as the one that seems to be closer to hu- basic Fibroblast Growth Factor-2 (FGF- man experimental implant, is the tran- scatheter valve developed by PVT- 2), Transforming Growth Factor β (TGF- Figure 2. Amin’s valve. Courtesy of Dr. Z. Edwards, modified for the pulmonary β ) and Vascular Endothelial Growth Fac- Amin. tor (VEGF). The SIS is mounted on a valve position and that is also balloon expandable (detailed explanation will very low profile, self-expandable stent intervention at 1 year was 91.7% with the that was based on the earlier square follow under the aortic valve implants). current design. There have been other So far there have been no reports on design of the venous valve,4 and the complications reported, such as three newer designs are self-centering and animal or human experimentation of this cases of late endocarditis and one case self-aligning. (Figure 3). valve. of intravascular hemolysis. Surgery post percutaneous valve implant was never Also, Dr. Zahid Amin has experimented The one year follow-up study post im- due to pulmonary insufficiency. Surgery with the Shelhigh No-React porcine pul- plantation performed in a swine model was necessary in a subgroup of five pa- monary valve mounted on Gianturco- with RV failure showed that the valve tients because of residual stenosis non- Rosch Z-stents and delivered by direct was successful in controlling pulmonary responsive to stent. Perhaps, though, access of the free wall of the RV through insufficiency and reversing the RV fail- the most important parameter is that a purse-string suture (Figure 2). ure, and the SIS tissue underwent pro- there has been no acute or late mortality. gressive and extensive remodeling with However there have been no human neovascularization and complete endo- Based on the current device design, the implant attempts of this device thus far. thelization after the first 3 months.5 How- selection of patients is limited to patients ever, there was an excessive remodeling Another type of pulmonary valve that is in older than 5 years and weight larger than noted mainly at the base of the leaflets, the animal experimentation phase, is the 20 Kg, with significant pulmonary insuffi- with some foreshortening; therefore, the Cook-SIS self expandable valve. This ciency with increasing RV dilatation and/ use of SIS as a cardiac valve tissue, valve is a modified venous valve that was or impaired exercise tolerance, as well as needs further and longer animal studies initially developed by Dusan Pavcnik those with RV outflow tract obstruction with RV pressures greater than 2/3 sys- temic. There is no question that, in part, the great success achieved by Bonhoeffer and collaborators is due to the intelligent and cautious approach in patient selec- tion.3 Rather than attempting implanta- tion of the valve in native structures, they elected to choose patients with conduits in whom the detailed anatomy is better known. Furthermore, the pulmonary Figure 3. Cook-SIS valve. 28th Annual Scientific Sessions and Melvin P. Judkins Cardiac Imaging Symposium May 4-7, 2005, Ponte Vedra Beach, Florida The Society for Cardiovascular Angiography and Interventions www.scai.org © Copyright 2005, Pediatric Cardiology Today. All rights reserved www.Ped iatricCard iolog y Today .com
  11. 11. PEDIATRIC CARDIOLOGY TODAY MARCH 2005 PAGE 11 before any attempts to human implanta- cardium treated by a proprietary physico- tion can be contemplated. chemical process technology that pro- duces a 40 µm thick biologically inactive Transcatheter Aortic Valve membrane with a smooth blood-surface Implantation contact and great strength. It is highly The concept of percutaneous interven- resistant to calcification in animal models tion for patients with severe aortic steno- at a relatively long-term implantation. sis was first introduced in 1986 by Cribier This material is tailored in a tubular fash- and Letac6 when they first performed ion and sutured to either a balloon ex- aortic balloon valvuloplasty in patients pandable (stainless steel) stent with an with severe calcific aortic stenosis. How- introducible diameter of Fr. #14 or to a ever, the initial success was very short self-expandable (nitinol) stent with an lived, and quickly it became obvious that introducible diameter of Fr. #11.9 (Figure the valvuloplasty procedure could not be 5). an alternative to valve replacement, but There is another transcatheter aortic could be used as a bridge to valve re- valve prosthesis that has recently en- placement in special circumstances. Figure 4. Cribier’s aortic valve. Courtesy of tered into phase one clinical trials, the Percutaneous Valve Technologies-Edwards Highly stimulated by the poor long-term LifeScience. CoreValve. This prosthesis is made of a results obtained with balloon valvu- self-expandable nitinol stent 50 mm long loplasty in calcific aortic stenosis,7 Alain and with variable diameters, it has a cover sheath to protect the stent, it would Cribier started to contemplate the possi- commercially available bovine pericardial be very hard to get across the heavily bility of mounting a biological valve in a valve sutured into the stent. The stent calcified aortic valves and therefore the large stent and placed across the calci- has a very high radial force and is able to majority of the implantations had to be fied valve. He first conducted some ca- effectively crush the native valvular calci- done in an anterograde approach, trans- daver studies and determined the length fications (Figure 6). septally, although they have also im- of the stent that would be needed to ef- planted in a retrograde approach. There The delivery catheter requires a Fr. #24 fectively hold a valve and not to interfere have been more than 20 valves im- introducer, and currently all human im- with the coronary blood flow. Based on planted and all patients were deemed plants have been done under fem-fem the Henning R. Anderson patent from inoperable by at least two cardiothoracic by-pass with a membrane oxygenator. February 2000, Percutaneous Valve surgical teams. Obviously, this kind of Technologies (PVT) developed the first patient selection for the transcatheter balloon expandable stented valve that implant of aortic valve prosthesis tilts the could be delivered by a catheter across balance toward having much higher risks the aortic valve. In April 2002, Alain for fatal complications, and therefore Cribier and colleagues successfully im- when analyzing the result one has to planted the first transcatheter aortic valve keep in mind this very important factor. prosthesis in a patient with severely cal- Nevertheless, significant para-valvular cified aortic stenosis.8 The current valve regurgitation and early mortality charac- is constructed from equine pericardium terize their experience thus far.9 and mounted on a 14 mm long x 23 mm diameter, highly resistant stainless steel Another pioneering work in the field of balloon expandable stent that is me- transcatheter aortic valve prosthesis has chanically crimped on a 23 mm Z-Med II been briefly reported by Paniagua and balloon valvuloplasty catheter. The collaborators,10 there has been only one mounted stented valve can be introduced successful human implant of this lower- through a Fr. #24 sheath. (Figure 4) profile transcatheter valve prosthesis. Figure 5. Paniagua’s valve. Courtesy of Dr. This prosthesis is built from porcine peri- David Paniagua Because the delivery system lacks a www.Ped iatricCard iolog y Today .com © Copyright 2005, Pediatric Cardiology Today. All rights reserved
  12. 12. PAGE 12 MARCH 2005 PEDIATRIC CARDIOLOGY TODAY Figure 7. Intracardiac echocardiogram guiding placement of CoreValve. The delivery of the prosthesis in some 28 mm in length and they have valves be reabsorbed or remodeled in combi- instances were guided by intracardiac from 15 to 23 mm in diameter and it nation with tissue-engineered valves as echocardiogram (ICE) using a Siemens requires a Fr. #22 introducer. pioneered by Dr. John Mayer from Har- AcuNav System (Figure 7). vard of Boston, and Sir Magdi Yacoub Also Dr. Philipp Bonhoeffer has report- from the Imperial College of London. There have been very few human im- ed11 an ingenious self-centering and plants done with this valve to the best self-orienting transcatheter aortic valve Certainly, we cannot complete this brief of my knowledge and their results have prosthesis using a combination of a review on transcatheter valve technolo- not yet been published, but their pilot self-expandable nitinol stent to orient gies without mentioning the efforts in study protocol is aimed at patients that and align and a balloon expandable developing mechanical, non-biological are good surgical candidates for valve stent to fix the valve without obstruct- prosthetic valves. The pioneering effort replacement. ing the coronary artery ostiums. (Figure began with Dusan Pavcnik when he 9). developed a transcatheter cage-ball There are other transcatheter aortic valve using modified Gianturco Z- valve prosthesis being developed and In addition of the above mentioned stents and an inflatable ball 12 – Fig- at different investigational stages, but transcatheter aortic valve prosthesis, ure 10. However, one of the most without any human implantation experi- there are many other start-up compa- exciting technologies using nano- ence, so far re- nies that are actively pursuing this new technology is the initial work being ported, such as technology in response to what prom- the self expand- ises to be a very able nitinol stent exciting future. The with active fixa- majority of the ef- tion barbs that forts are being fo- uses either por- cused on developing cine aortic valve biological prosthe- or porcine peri- sis; these include cardium (Figure finding the right bio- 8), that was de- material. There are veloped and re- many fascinating ported by Lutter projects in the works Figure 6. The G, et al. 11 including the use of CoreValve. Courtesy biologically inactive The stent is 21 to Figure 8. Lutter’s valve. Courtesy of Dr. G. Lutter. of CoreValve. scaffolds that can The Barth Syndrome Foundation P.O. Box 974, Perry, FL 32348 Tel: 850.223.1128 info@barthsyndrome.org www.barthsyndrome.org Symptoms: Cardiomyopathy, Neutropenia, Muscle Weakness, Exercise Intolerance, Growth Retardation © Copyright 2005, Pediatric Cardiology Today. All rights reserved www.Ped iatricCard iolog y Today .com
  13. 13. PEDIATRIC CARDIOLOGY TODAY MARCH 2005 PAGE 13 done by Dr. Steven Bailey from the University of Texas in San Antonio. At our First Transcatheter Valve Sympo- sium celebrated in London in March of 2004, he reported that using a vacuum deposition developmental system, a 3D-Spluttering Magnetron, basically they would load it with metals in their pure state, and by using a chamber pressurized at 1012 Atm. In the pres- ence of an anode and a cathode, spe- cific ions are driven to the center where there is a mold, that can perform 3D stereometric assembly. This, allows them to control the thickness of the material down to 4µm, therefore omit- ting the need for thinning the metal. Figure 10. Pavcnik’s valve. Courtesy of Dr. D. Pavcnik. Furthermore, this allows them also to control the expansion characteristic or ter implant of this mechanical valve in with less invasive means of treating elasticity of the new metal. Using this the animal model with a very high rate valvular heart disease. In this manu- technology they have been able to de- of success and minimal complications script we briefly commented on the out- velop metallic membranes that have in the mid-term follow-up. flow cardiac valves, pulmonic and aor- been used as vascular graft as well as tic, however it will not be long before Transcatheter cardiac valve prosthesis developing valve leaflets (Figure 11). the firsts reports appear on the efforts is an emerging technology with a phe- that many of us are developing to con- He reported the successful transcathe- nomenal potential for providing patients struct a feasible and safe transcatheter in-flow cardiac valve, i.e., mitral and tricuspid. Aside from these galloping technologies there will be other crucial issues that will need to be addressed before the use of these technologies can be offered as a true therapeutic alternative for some patients. First, we need to really convince ourselves and the regulatory agencies throughout the world that these devices are equivalent to the ones that are in use today. How- ever, durability of the prosthesis will need to be put in perspective depend- ing on the intended use of the device. But what is certain in my view is that these procedures should be “safer” than the current surgical techniques, with less co-morbidity and mortality for this technology before they have a chance to become the gold standard. Figure 9. Bonhoeffer’s aortic valve. Courtesy of Dr. P. Bonhoeffer. Therefore, we will need a true collabo- www.Ped iatricCard iolog y Today .com © Copyright 2005, Pediatric Cardiology Today. All rights reserved
  14. 14. PAGE 14 MARCH 2005 PEDIATRIC CARDIOLOGY TODAY mostly in animals and a few in humans, case description. Circulation 106:3006- that in order to make these procedures 3008, 2002. safe and effective we must also partner 9. Paniagua D, Induni E, Ortiz C, et with the leaders in imaging industry, to al.: Percutaneous Heart Valve in the develop better and more realistic imag- Chronic In Vitro Testing Model. Circula- ing modalities. tion 106: 51–52, 2002. References 10. Lutter G, Kuklinski D, Berg G, et 1. Harken DE, Soroff HS, Taylor WJ, al.: Percutaneous aortic valve replace- et al: Partial and complete prostheses ment: An experimental study. I. Studies in aortic insufficiency. J Thorac Car- on implantation. Journal of Thoracic & diovasc Surg 1960; 40: 744. Cardiovascular Surgery. 123(4):768- 776, 2002. 2. Bonhoeffer P, Younes B, Zakhia S, et al: Percutaneous replacement of 11. Cribier A, Eltchaninoff H, Tron C, pulmonary valve in a right-ventricle to et al.: Early experience with percutane- pulmonary-artery prosthetic conduit ous transcatheter implantation of heart with valve dysfunction. Lancet 356: valve prosthesis for the treatment of 1403-1405, 2000. end-stage inoperable patients with cal- Figure 11. Bailey’s valve. Courtesy of cific aortic stenosis. J Am Coll Cardiol 3. Bonhoeffer P, Boudjemline Y, Qure- Dr. S. Bailey. 43:698-703, 2004. shi SA, et al.: Percutaneous insertion of the pulmonary valve. J Am Coll Car- 12. Pavcnik D. Wright KC. Wallace S.: ration among cardiac surgeons, cardi- diol 39:1664-1669, 2002. Development and initial experimental ologist, engineers, basic scientists, etc. evaluation of a prosthetic aortic valve when trying to prove the safety and 4. Pavcnik D. Uchida BT. Timmermans for transcatheter placement. Work in efficacy of these devices. Trial design, H. et al.: The square stent-based large progress. Radiology. 183(1):151-4, control groups, end-points for assess- vessel occluder: an experimental pilot 1992. ment, investigator and institutional re- study. Journal of Vascular & Interven- tional Radiology. 11(9):1227-34, 2000. For comments to this article, send email to: quirements, as well as specific safety MARCER@PediatricCardiologyToday.com issues are going to be crucial. This will 5. Ruiz CE, …….. need to be put in the perspective that, ~PCT~ for almost all patients open cardiac 6. Cribier A, Savin T, Saoudi N, et al.: surgical valve replacement is the gold Percutaneous transluminal valvu- standard, and the few considered inop- loplasty of acquired aortic stenosis in erable, will need to be well defined with elderly patients: An alternative to valve a unified rigorous criteria for “non- replacement? Lancet 1:63-67, 1986. operable” across the board. 7. O’Neil WWand Mansfield Scientific Finally, I think that perhaps one of the Aortic Valvuloplasty Regestry Investi- main handicaps to the advancement of gators.: Predictors of long term survival these technologies is due to the lack of after percutaneous aortic valvuloplasty: optimal imaging technology. The sur- Report of the Mansfield Scientific Aortic geons in the operating theater have Valvuloplasty Regestry. J Am Coll Car- Carlos E. Ruiz, MD, PhD indeed the ultimate imaging technol- diol 17:909-913, 1991. Professor and Chief ogy, their own eyes, with or without 8. Cribier A, Eltchaninoff H, Bash A, et Division of Pediatric Cardiology magnifying lenses. There is no ques- al.: Percutaneous transcatheter im- University of Illinois at Chicago tion in my mind, after having implanted plantation of an aortic valve prosthesis many transcatheter valve prosthesis, cru izmd @u ic.edu for calcific aortic stenosis. First human The 1st Annual Toronto Symposium: Contemporary Questions In Congenital Heart Disease 2005 May 29-31, 2005; Toronto, Ontario, Canada w w w .s i ck ki ds . ca /c a rdi ol og y © Copyright 2005, Pediatric Cardiology Today. All rights reserved www.Ped iatricCard iolog y Today .com
  15. 15. PEDIATRIC CARDIOLOGY TODAY MARCH 2005 PAGE 15 M E D I C A L N E W S A N D I N F O R M AT I O N China's Medical Device Industry Forecasted to Become accuracy in the placement of the Worlds Largest products into categories. ( PRWEB) - The medical device industry in China is growing Bill Goodwin, Publisher of at 17% per year and forecasted to continue this incredible China Medbook says, "This growth rate for the next 10 years. China Medbook, a new project, which has taken over directory and industry reports from Life Sciences Publishing 2 years and 40,000 man- (LSP) provides complete information on the industry and hours, will increase and facili- profiles 9,000 manufacturers. Manufacturers in China are tate 2-way trade with China, expanding rapidly in size and in their numbers. There are a vital market for the world's now over 9,000 device firms in China and this number will major medical device firms. soon pass the United States. They are not only meeting the Lack of quality information is needs of China's massive market, but export sales of medi- an obstacle for western firms cal devices are growing at 25% a year as shown in a report who want to do business in from China Customs. To facilitate global trade with China's China. China Medbook will China Medbook from Life Science explosive medical device industry Life Sciences Publishing save users hundreds of Publishing announces the launch of China Medbook, the world's first hours in sourcing made in medical device industry directory for China. China Medbook china medical devices, equipment, dental supplies, labora- provides complete information on the industry with in-depth tory products and diagnostic products". profiles of 9,000 manufacturers. Information provided by Included in China Medbook is a market research report with China Customs Department illustrates that it is manufactur- pertinent industry and marketing data. Tradeshows across ers in the United States and Europe who are getting the China are included along with a list of all relevant organiza- most benefit from this growth with China imports of medical tions and agencies involved in the development of medical devices up by an astounding 34% as of the September 30th, standards. Current import and export data are in separate 2004. China's State Food and Drug Administration has re- tables. A list of all trade publications and journals is included cently mandated Good Manufacturing Practices for all medi- along with contact details. Purchasers of China Medbook cal device manufacturers which is expected to increase the who cannot locate a particular product or company can ob- quality and reliability of medical devices made in China and tain free assistance from LSP staff for 1 year after date of allow them to compete globally. This will only enhance the purchase. dramatic growth already underway. For more information: www.lifesciencespublishing.com China Medbook contains accurate and detailed information on all firms in both Mainland China (8,000), Taiwan & Hong Kong (1,000). Information provided includes phone, fax, e- mail and postal addresses. Also included are key personnel, Elizabeth G. Nabel, MD, Named New Director of the number of employees and registered capital. The directory National Heart, Lung, and Blood Institute has 3 sections: the 1st section sorts manufacturers by over Dr. Nabel, whose appointment began on February 1, 2005, 200 different categories allowing users to find companies by will oversee an annual budget of almost $3 billion and a staff product. The 2nd sorts companies geographically and the of approximately 850 Federal employees. The Institute pro- 3rd is organized by company profile. vides leadership for a national research program on heart, A detailed verification process undertaken by LSP's profes- lung, blood, and sleep diseases and disorders. Since 1993, sional bilingual staff of software engineers, information spe- the Institute has been the home of the National Center on cialists, and data entry specialists ensures that the data Sleep Disorders Research and, since 1998, it has had re- found in China Medbook is accurate. A team of Medical sponsibility for the NIH Women's Health Initiative. Institute- Doctors reviewed each manufacturer's products to ensure funded research is conducted in Bethesda, Maryland in the NHLBI's intramural laboratories and throughout the country www.Ped iatricCard iolog y Today .com © Copyright 2005, Pediatric Cardiology Today. All rights reserved

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