 |
|
Three Patients, Age 14, 28 and 72, Receive Heart Valve Replacements without Surgery Using High Tech Investigational Device
April 21, 2008Non-Surgical Procedure Permits Swift Recovery and Discharge from Hospital
CHICAGO - Interventional cardiologists at Rush University Medical Center now offer a minimally-invasive transcatheter valve replacement procedure for patients with congenital heart disease that doesn't involve open heart surgery.
Rush is one of three sites taking part in the investigational device exemption (IDE) feasibility study of minimally-invasive pulmonic valves and successfully implanted the first three patients enrolled in the trial on Thursday, April 17.
"We were able to successfully implant the Edwards SAPIEN transcatheter heart valve percutaneously in the first three patients treated in this trial. All of the patients are recovering and are expected to go home today," said Dr. Ziyad M. Hijazi, director of the Rush Center for Congenital and Structural Heart Disease, chief of the section of pediatric cardiology and professor in the departments of pediatrics and internal medicine at Rush University, Chicago. "Patients with congenital right ventricular outflow tract problems typically face the burden of multiple open-heart surgeries throughout their lives, either to replace their 'native' diseased valves or, as they age, their bioprosthetic replacement valves."
Hijazi, an interventional cardiologist and pioneer in nonsurgical repair of the heart, and his colleagues, Dr. Clifford J. Kavinsky and Dr. Zahid Amin, used a bovine pericardial heart valve that can be compressed onto a balloon to the approximate diameter of a pencil, threaded from the leg into the circulatory system and deployed across the patient's pulmonary valve. The valve replacement is accomplished as a "beating heart" procedure, without requiring cardiopulmonary bypass or an open-chest incision.
Edwards Lifesciences Corporation of Irvine, Calif., makes the Edwards SAPIEN transcatheter valve that was implanted.
"We can replace heart valves in high-risk patients with severe pulmonary stenosis (abnormal narrowing in a blood vessel) who might not be candidates for conventional valve replacement surgery. Instead, these patients can benefit from a transcatheter valve replacement procedure done minimally-invasively, without cardio-pulmonary bypass, that has the potential to shorten recovery time," said Hijazi.. "This clinical study will enable physicians to offer a minimally-invasive alternative to symptomatic patients with a regurgitant, or leaky, pulmonary valve conduit, giving them the opportunity to recover and resume their normal activities."
"My team is proud to be able to address this serious unmet patient need and to offer the chance to take one or more surgeries out of the treatment course for these patients," said Hijazi.
The U.S. Food and Drug Administration (FDA) conditionally approved the investigational device exemption (IDE) clinical trial in late 2007. The study of 30 patients at three hospitals will enable the collection of safety and effectiveness data, ultimately in support of a commercial approval application.
Rush University Medical Center
"We were able to successfully implant the Edwards SAPIEN transcatheter heart valve percutaneously in the first three patients treated in this trial. All of the patients are recovering and are expected to go home today," said Dr. Ziyad M. Hijazi, director of the Rush Center for Congenital and Structural Heart Disease, chief of the section of pediatric cardiology and professor in the departments of pediatrics and internal medicine at Rush University, Chicago. "Patients with congenital right ventricular outflow tract problems typically face the burden of multiple open-heart surgeries throughout their lives, either to replace their 'native' diseased valves or, as they age, their bioprosthetic replacement valves."
Hijazi, an interventional cardiologist and pioneer in nonsurgical repair of the heart, and his colleagues, Dr. Clifford J. Kavinsky and Dr. Zahid Amin, used a bovine pericardial heart valve that can be compressed onto a balloon to the approximate diameter of a pencil, threaded from the leg into the circulatory system and deployed across the patient's pulmonary valve. The valve replacement is accomplished as a "beating heart" procedure, without requiring cardiopulmonary bypass or an open-chest incision.
Edwards Lifesciences Corporation of Irvine, Calif., makes the Edwards SAPIEN transcatheter valve that was implanted.
"We can replace heart valves in high-risk patients with severe pulmonary stenosis (abnormal narrowing in a blood vessel) who might not be candidates for conventional valve replacement surgery. Instead, these patients can benefit from a transcatheter valve replacement procedure done minimally-invasively, without cardio-pulmonary bypass, that has the potential to shorten recovery time," said Hijazi.. "This clinical study will enable physicians to offer a minimally-invasive alternative to symptomatic patients with a regurgitant, or leaky, pulmonary valve conduit, giving them the opportunity to recover and resume their normal activities."
"My team is proud to be able to address this serious unmet patient need and to offer the chance to take one or more surgeries out of the treatment course for these patients," said Hijazi.
The U.S. Food and Drug Administration (FDA) conditionally approved the investigational device exemption (IDE) clinical trial in late 2007. The study of 30 patients at three hospitals will enable the collection of safety and effectiveness data, ultimately in support of a commercial approval application.
Rush University Medical Center
Death rates decline following coronary bypass surgery regardless of hospital volume
Rates of death following coronary artery bypass graft (CABG) surgery have declined since 1997 while the number of procedures performed has decreased, according to a report in the April issue of Archives of Surgery, one of the JAMA/Archives journals.
Same-day coronary angiography and surgery safe for many patients
Mayo Clinic researchers discovered it is safe -- and much more convenient and less costly -- for many patients to undergo coronary angiography and elective valve surgery on the same day, it is reported in the current issue of Mayo Clinic Proceedings.
Vitamin K discovery may lead to new treatments for patients at risk from blood clots
Medical Research Council (MRC) scientists have discovered more about the role that vitamin K plays in the complicated process of how blood clots. Their work, published in Nature, may lead to new treatments for patients at risk from blood clots, including those who have had heart attacks, have coronary artery disease, irregular heart beats, or have had heart valve replacement therapy. The scientists from the MRC's Clinical Sciences Centre at Imperial College, and research institutions in Germany, identified the gene which controls the production of a protein essential for the action of vitamin K, which is necessary for the formation of a clot. Warfarin is currently the best treatment for pati
Information for heart valve patients must improve
Patients who have had heart valves replaced should receive an implant card after their operation. This is to ensure that any future complications associated with particular valves can be quickly identified and treated. But a study in this week's BMJ finds that present implant card schemes are falling well below acceptable standards. Over 1,900 patients who underwent heart valve replacement in 1998 responded to a questionnaire about the date of their operation, if they had received an implant card, and the interval between operation and card receipt. Nearly half of the patients had not received an implant card 12 months after their operation. Furthermore, patients who had not received the imp
More Heart Valve Replacement Current Events and Heart Valve Replacement News Articles
 | The Patient's Guide To Heart Valve Surgery (Heart Valve Replacement And Heart Valve Repair) by Adam Pick Each year, over 250,000 heart valve repair and heart valve replacement operations are performed for conditions including stenosis, prolapse, insufficiency, aneurysm, Tetralogy of Fallot and regurgitation. As a result, patients experience several different types of cardiac bypass surgery including aortic valve replacement, mitral valve repair and the Ross Procedure. HOWEVER... DID YOU KNOW?In a... |
| Controversies in Heart Valve Replacement (1986) by D. Horstkotte, H.P. Krayenbuhl | |
| Gale Encyclopedia of Medicine: Heart valve replacement by Karen Marie Sandrick The article is excerpted from Gale Encyclopedia of Medicine. Consult the second edition of this authoritative, comprehensive, in-depth medical guide for information on more than 1,700 medical topics in language accessible to adult laypersons. Presented in a single alphabetical sequence, articles range in length from one or two paragraphs for minor topics, to several pages or more for major... | |
| Indications for Heart Valve Replacement by Age Group | |
| Needle left in pt. during heart valve replacement surgery.(Medical Law Case of the Month): An article from: Medical Law's Regan Report by A. David Tammelleo This digital document is an article from Medical Law's Regan Report, published by Medica Press, Inc. on January 1, 2003. The length of the article is 914 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.Citation... | |
| Biological tissue in heart valve replacement; by Marian I Ionescu | |
| The Pathology of Heart Valve Replacement by A.G. Rose | |
| Heart Valve Replacement by P.J.K. Starek | |
| Heart Valve Replacement & Future Trends in Cardiac Surgery by Gregorio Rabago | |
| Update in Heart Valve Replacement: Proceedings of the Second European Symposium on St.Jude Medical Heart Valve |
| © 2008 BrightSurf.com |