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- W2065647698 abstract "Percutaneous valve implantation is the development of a foldable heart valve that can be mounted on an expandable stent delivered percutaneously through standard catheter-based techniques and implanted within a diseased valve annulus. In cases with severe aortic stenosis, the diseased valve has to be pre-dilated. To perform a true replacement the diseased valve has to be ablated and removed. In this article, we review the development of percutaneous valve replacement technology and discuss future prospects in this field. Percutaneous valve implantation is the development of a foldable heart valve that can be mounted on an expandable stent delivered percutaneously through standard catheter-based techniques and implanted within a diseased valve annulus. In cases with severe aortic stenosis, the diseased valve has to be pre-dilated. To perform a true replacement the diseased valve has to be ablated and removed. In this article, we review the development of percutaneous valve replacement technology and discuss future prospects in this field. The field of interventional cardiology is one of the most rapidly evolving and vibrant areas in today's medicine. Although surgical treatment of diseased heart valves has proven to be the ultimate curative approach for these patients, recent reports indicate that endovascular procedures may provide an alternative to open heart operations [1Andersen H.R. Knudsen L.L. Hasenkam J.M. Transluminal implantation of artificial heart valves Description of new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs.Eur Heart J. 1992; 13: 704-708Crossref PubMed Scopus (421) Google Scholar, 2Bonhoeffer P. Boudjemline Y. Saliba Z. et al.Transcatheter implantation of a bovine valve in pulmonary position: a lamb study.Circulation. 2000; 102: 813-816Crossref PubMed Scopus (244) Google Scholar, 3Cribier A. Eltchaninoff H. Bash A. et al.Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description.Circulation. 2002; 106: 3006-3008Crossref PubMed Scopus (2520) Google Scholar, 4Lutter G. Kuklinski D. Berg G. et al.Percutaneous aortic valve replacement: an experimental study I. Studies on implantation.J Thorac Cardiovasc Surg. 2002; 123: 768-776Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar].Percutaneous valve implantation is the development of a foldable heart valve that can be mounted on an expandable stent [1Andersen H.R. Knudsen L.L. Hasenkam J.M. Transluminal implantation of artificial heart valves Description of new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs.Eur Heart J. 1992; 13: 704-708Crossref PubMed Scopus (421) Google Scholar, 2Bonhoeffer P. Boudjemline Y. Saliba Z. et al.Transcatheter implantation of a bovine valve in pulmonary position: a lamb study.Circulation. 2000; 102: 813-816Crossref PubMed Scopus (244) Google Scholar, 3Cribier A. Eltchaninoff H. Bash A. et al.Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description.Circulation. 2002; 106: 3006-3008Crossref PubMed Scopus (2520) Google Scholar, 4Lutter G. Kuklinski D. Berg G. et al.Percutaneous aortic valve replacement: an experimental study I. Studies on implantation.J Thorac Cardiovasc Surg. 2002; 123: 768-776Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar], delivered percutaneously through standard catheter-based techniques [5Pavcnik D. Wright K.C. Wallace S. Development and initial experimental evaluation of a prosthetic aortic valve for transcatheter placement: work in progress.Radiology. 1992; 183: 151-154Crossref PubMed Scopus (80) Google Scholar, 6Boudjemline Y. Bonhoeffer P. Steps toward percutaneous valve replacement.Circulation. 2002; 105: 775-778Crossref PubMed Scopus (143) Google Scholar] and implanted within a diseased valve annulus [3Cribier A. Eltchaninoff H. Bash A. et al.Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description.Circulation. 2002; 106: 3006-3008Crossref PubMed Scopus (2520) Google Scholar, 4Lutter G. Kuklinski D. Berg G. et al.Percutaneous aortic valve replacement: an experimental study I. Studies on implantation.J Thorac Cardiovasc Surg. 2002; 123: 768-776Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar]. In cases with severe aortic stenosis the diseased valve has to be pre-dilated [3Cribier A. Eltchaninoff H. Bash A. et al.Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description.Circulation. 2002; 106: 3006-3008Crossref PubMed Scopus (2520) Google Scholar], although to perform a true replacement, the diseased valve has to be ablated and removed [4Lutter G. Kuklinski D. Berg G. et al.Percutaneous aortic valve replacement: an experimental study I. Studies on implantation.J Thorac Cardiovasc Surg. 2002; 123: 768-776Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar]. It is imperative that such an implant has a fixed and stable intraluminary position, that it provides adequate hemodynamics [4Lutter G. Kuklinski D. Berg G. et al.Percutaneous aortic valve replacement: an experimental study I. Studies on implantation.J Thorac Cardiovasc Surg. 2002; 123: 768-776Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar], and in the case of an aortic valve, that it does not compromise coronary flow [1Andersen H.R. Knudsen L.L. Hasenkam J.M. Transluminal implantation of artificial heart valves Description of new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs.Eur Heart J. 1992; 13: 704-708Crossref PubMed Scopus (421) Google Scholar, 2Bonhoeffer P. Boudjemline Y. Saliba Z. et al.Transcatheter implantation of a bovine valve in pulmonary position: a lamb study.Circulation. 2000; 102: 813-816Crossref PubMed Scopus (244) Google Scholar, 4Lutter G. Kuklinski D. Berg G. et al.Percutaneous aortic valve replacement: an experimental study I. Studies on implantation.J Thorac Cardiovasc Surg. 2002; 123: 768-776Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar]. This novel concept has evolved by extensive trial and error and has been tested in several animal models with success [1Andersen H.R. Knudsen L.L. Hasenkam J.M. Transluminal implantation of artificial heart valves Description of new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs.Eur Heart J. 1992; 13: 704-708Crossref PubMed Scopus (421) Google Scholar, 2Bonhoeffer P. Boudjemline Y. Saliba Z. et al.Transcatheter implantation of a bovine valve in pulmonary position: a lamb study.Circulation. 2000; 102: 813-816Crossref PubMed Scopus (244) Google Scholar, 4Lutter G. Kuklinski D. Berg G. et al.Percutaneous aortic valve replacement: an experimental study I. Studies on implantation.J Thorac Cardiovasc Surg. 2002; 123: 768-776Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar, 5Pavcnik D. Wright K.C. Wallace S. Development and initial experimental evaluation of a prosthetic aortic valve for transcatheter placement: work in progress.Radiology. 1992; 183: 151-154Crossref PubMed Scopus (80) Google Scholar, 6Boudjemline Y. Bonhoeffer P. Steps toward percutaneous valve replacement.Circulation. 2002; 105: 775-778Crossref PubMed Scopus (143) Google Scholar]. Furthermore, recent reports of percutaneous implantation of pulmonary valves in pediatric patients [7Bonhoeffer P. Boudjemline Y. Saliba Z. et al.Percutaneous replacement of a pulmonary valve in a right ventricle to pulmonary artery conduit.Lancet. 2000; 356: 1403-1405Abstract Full Text Full Text PDF PubMed Scopus (799) Google Scholar, 8Bonhoeffer P. Boudjemline Y. Qureshi S. et al.Percutaneous insertion of the pulmonary valve.J Am Coll Cardiol. 2002; 39: 1664-1669Abstract Full Text Full Text PDF PubMed Scopus (272) Google Scholar], as well as aortic valves in adults [3Cribier A. Eltchaninoff H. Bash A. et al.Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description.Circulation. 2002; 106: 3006-3008Crossref PubMed Scopus (2520) Google Scholar], indicate that percutaneous valve implantation may become an effective and versatile procedure, which could benefit a large patient population [1Andersen H.R. Knudsen L.L. Hasenkam J.M. Transluminal implantation of artificial heart valves Description of new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs.Eur Heart J. 1992; 13: 704-708Crossref PubMed Scopus (421) Google Scholar, 4Lutter G. Kuklinski D. Berg G. et al.Percutaneous aortic valve replacement: an experimental study I. Studies on implantation.J Thorac Cardiovasc Surg. 2002; 123: 768-776Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar, 9Levi D.S. Alejos J.C. Moore J.W. Future of interventional cardiology in pediatrics.Curr Opin Cardiol. 2003; 18: 79-90Crossref PubMed Scopus (13) Google Scholar, 10Lutter G, v Samson P, Kuklinski D, et al. A new percutaneous transluminal technique for minimal aortic valve replacement. Circulation 2001;104:II-552.Google Scholar]. In this article, we review the development of percutaneous valve replacement technology and discuss future prospects in this field.In this review, books, journal articles, reviews, and meeting abstracts reporting on experimental and clinical work were analyzed and are to some extent included. The literature acquisition was performed in the 1966 through May 2004 database of Medline and the “all years” database from the Web of Science. The following keywords were used in the searches (both in American and Oxford English): percutaneous valve replacement, transluminal valve replacement, transcatheter valve replacement, percutaneous valve implantation, percutaneous valve insertion, transluminal valve implantation, transcatheter heart valve implantation, percutaneous balloon valvuloplasty, transluminal balloon valvuloplasty, percutaneous balloon dilatation, valved stent, expandable stent-valve, percutaneous heart valve, endovascular stent graft, prosthetic heart valve, prosthesis, heart valve disease, valves, stents, prosthesis, filters, catheterization, catheter-based procedures, catheter-mediated treatment, catheter-based intervention, interventional procedures, percutaneous heart valve excision, and percutaneous heart valve ablation.Evolution of Treatment Options for Valvular Heart DiseaseThe evolution of percutaneous aortic valve implantation parallels that of its surgical development. In 1951, Hufnagel and colleagues [11Hufnagel C.A. Harvey W.P. Rabil P.J. et al.Surgical correction of aortic insufficency.Surg. 1954; 35: 673-683PubMed Google Scholar] surgically implanted a prosthetic ball valve device in the proximal descending aorta of patients with aortic insufficiency and prevented regurgitation into the left ventricle. In 1992, 40 years later, similar attempts were made by two separate groups to implant prosthetic heart valves transluminally in closed chest animals. Since then several groups have made significant contributions to this development (Table 1). In 1992, Andersen and coworkers [1Andersen H.R. Knudsen L.L. Hasenkam J.M. Transluminal implantation of artificial heart valves Description of new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs.Eur Heart J. 1992; 13: 704-708Crossref PubMed Scopus (421) Google Scholar] demonstrated that artificial aortic valves could be implanted in closed-chest pigs by means of a transluminal catheter technique for the first time. The expandable aortic valve was mounted on a balloon catheter and was inserted retrogradely into the descending, ascending, or the aortic root in anesthetized pigs. Although implantation in the ascending aorta revealed adequate hemodynamics across the valve, subcoronary implantation resulted in restriction of the coronary blood flow. That same year, Pavcnik and colleagues [5Pavcnik D. Wright K.C. Wallace S. Development and initial experimental evaluation of a prosthetic aortic valve for transcatheter placement: work in progress.Radiology. 1992; 183: 151-154Crossref PubMed Scopus (80) Google Scholar] showed that a percutaneous transcatheter placement of an artificial caged-ball valve in dogs is feasible. However, a major difficulty associated with this design was the secured positioning of the cage and the ball. In all tested animals, the assembly failed to remain stable in a dynamic environment, leading to the escape of the ball through the top of the cage.Table 1Evolution of Percutaneous Valve ReplacementInvestigators/YearExperimental SubjectsStent SystemDelivery TechniqueMajor ComplicationsAndersen et al 1992 [1Andersen H.R. Knudsen L.L. Hasenkam J.M. Transluminal implantation of artificial heart valves Description of new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs.Eur Heart J. 1992; 13: 704-708Crossref PubMed Scopus (421) Google Scholar]Short-term study in pigs.Porcine aortic valve mounted into an expandable stentRetrograde delivery through the suprarenal aorta into the ascending aorta for sub- and supracoronary implantationRestriction of coronary flow and trivial regurgitationPavcnik et al 1992 [5Pavcnik D. Wright K.C. Wallace S. Development and initial experimental evaluation of a prosthetic aortic valve for transcatheter placement: work in progress.Radiology. 1992; 183: 151-154Crossref PubMed Scopus (80) Google Scholar]Short-term study in dogs.Self-expanding caged-ball aortic valveRetrograde delivery through the carotid into the ascending aorta for subcoronary implantation.Significant aortic regurgitation. System dis-assembly with escaping of the ball out of cage.Bonhoeffer et al 2000 [2Bonhoeffer P. Boudjemline Y. Saliba Z. et al.Transcatheter implantation of a bovine valve in pulmonary position: a lamb study.Circulation. 2000; 102: 813-816Crossref PubMed Scopus (244) Google Scholar]Long-term study in lambs.Bovine jugular vein valves sutured into an expandable stentAntegrade delivery through the jugular vein into the native pulmonary valve position.Pannus formation of valve leaflets.Lutter et al 2001/2002 [4Lutter G. Kuklinski D. Berg G. et al.Percutaneous aortic valve replacement: an experimental study I. Studies on implantation.J Thorac Cardiovasc Surg. 2002; 123: 768-776Abstract Full Text Full Text PDF PubMed Scopus (118) Google Scholar, 10Lutter G, v Samson P, Kuklinski D, et al. A new percutaneous transluminal technique for minimal aortic valve replacement. Circulation 2001;104:II-552.Google Scholar]Short-term study in pigs.Porcine aortic valves or pericardium sutured into a self expanding stentRetrograde delivery through iliac artery or infrarenal aorta for descending or ascending implantation.Restriction of coronary flow. Twisting of stents leading to high grade regurgitation. Rhythm disturbances.Boudjemline et al 2002 [6Boudjemline Y. Bonhoeffer P. Steps toward percutaneous valve replacement.Circulation. 2002; 105: 775-778Crossref PubMed Scopus (143) Google Scholar]Short term study in lambs.Bovine jugular vein valves sutured into an expandable stentRetrograde delivery through the carotid into the aortic valve annulus, trapping native leaflets between the outer nitinol stent and the inner platinum stent.Obstruction of coronary orifices, mitral valve insufficiency, and premature stent migration.Bonhoeffer et al 2002 [8Bonhoeffer P. Boudjemline Y. Qureshi S. et al.Percutaneous insertion of the pulmonary valve.J Am Coll Cardiol. 2002; 39: 1664-1669Abstract Full Text Full Text PDF PubMed Scopus (272) Google Scholar]Seven children and one adult with significant PR and/or RV outflow obstruction.Commercial biological valve sutured into a platinum stentAntegrade delivery through femoral vein into the pulmonary position.Possible valve degeneration.Cribier et al 2002 [3Cribier A. Eltchaninoff H. Bash A. et al.Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description.Circulation. 2002; 106: 3006-3008Crossref PubMed Scopus (2520) Google Scholar]57 year old man with calcific aortic stenosis and no other treatment option.Commercially available bovine pericardial leaflets mounted within a balloon expandable stentAntegrade transseptal approach with implantation into the diseased native aortic valveMild paravalvular regurgitation. Non-cardiac complications leading to patient's death 17 weeks after valve implantation.Cribier et al. 2004 [28Cribier A. Eltchaninoff H. Tron C. et al.Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis.J Am Coll Cardiol. 2004; 43: 698-703Abstract Full Text Full Text PDF PubMed Scopus (569) Google Scholar]Six patients with calcific aortic stenosisCommercially available bovine pericardial leaflets mounted within balloon expandable stentAntegrade transseptal approach with implantation within the diseased native aortic valve.Early migration with subsequent death in one patient. Mild paravalvular regurgitation. Open table in a new tab All current surgical approaches to valve replacement require cardiopulmonary bypass with or without cardioplegic arrest (ie, open heart surgery). The advent of intravascular aortic clamping and percutaneous coronary and coronary sinus cardioplegia delivery systems has permitted performance of valvular heart surgery through smaller versions of traditional thoracotomy incisions [12Sharony R. Grossi E.A. Saunders P.C. et al.Minimally invasive aortic valve surgery in the elderly: a case-control study.Circulation. 2003; 108: II43-7PubMed Google Scholar]. In the past decade, a broad spectrum of new surgical techniques and technical innovations to further minimize operation has been fostered, including robotically assisted video-enhanced valve repairs [13Grossi E.A. Galloway A.C. Ribakove G.H. et al.Impact of minimally invasive valvular heart surgery: a case-control study.Ann Thorac Surg. 2001; 71: 807-810Abstract Full Text Full Text PDF PubMed Scopus (100) Google Scholar] and sutureless techniques for anchoring the prosthesis [14Nifong L.W. Chu Y.F. Bailey B.M. et al.Robotic mitral valve repair: experience with the da Vinci system.Ann Thorac Surg. 2003; 75: 438-442Abstract Full Text Full Text PDF PubMed Scopus (162) Google Scholar] or annuloplasty band [15Magovern G.J. Liebler G.A. Park S.B. et al.Twenty-five-year review of the Magovern-Cromie sutureless aortic valve.Ann Thorac Surg. 1989; 48: S33-4Abstract Full Text PDF PubMed Scopus (38) Google Scholar]. The future trend in cardiac surgery is the development of minimally invasive procedures to minimize patient trauma [16Reade C.C. Bower C.E. Maziarz D.M. et al.Sutureless robot-assisted mitral valve repair: an animal model.Heart Surg Forum. 2003; 6: 254-257PubMed Google Scholar].Despite efforts to minimize the invasiveness of operations, a large number of risks associated with such surgical procedures still exist. An approach that would offer a similar or superior outcome to the conventional surgical technique only involves minimal intervention without general anesthesia and cosmetic scarring, and lower overall cost has been the basis for the emergence of percutaneous valve replacement.Percutaneous Valve Replacement: Novel Ideas Turned Into RealityUntil 1982 the traditional method of treatment for congenital pulmonary stenosis was surgical valvotomy, when Kan and colleagues [17Kan J.S. White Jr, R.I. Mitchell S.E. Gardner T.J. Percutaneous balloon valvuloplasty: a new method for treating congenital pulmonary-valve stenosis.N Engl J Med. 1982; 307: 540-542Crossref PubMed Scopus (551) Google Scholar] first reported successful application of percutaneous balloon valvuloplasty. The results of the procedure have been so successful that in recent years it has largely replaced surgical valvotomy except in patients with dysplastic valves [17Kan J.S. White Jr, R.I. Mitchell S.E. Gardner T.J. Percutaneous balloon valvuloplasty: a new method for treating congenital pulmonary-valve stenosis.N Engl J Med. 1982; 307: 540-542Crossref PubMed Scopus (551) Google Scholar, 18Kaye D.M. Byrne M. Alferness C. Power J. Feasibility and short-term efficacy of percutaneous mitral annular reduction for the therapy of heart failure-induced mitral regurgitation.Circulation. 2003; 108: 1795-1797Crossref PubMed Scopus (127) Google Scholar]. Percutaneous valvuloplasty has now become the routine and effective procedure of choice for congenital stenotic valves [19Block P. Palacios I.F. Clinical and hemodynamic follow-up after percutaneous aortic valvuloplasty in the elderly.Am J Cardiol. 1988; 62: 760-763Abstract Full Text PDF PubMed Scopus (110) Google Scholar, 20McKay R.G. The Mansfield Scientific Aortic Valvuloplasty Registry: overview of acute hemodynamic results and procedural complications.J Am Coll Cardiol. 1991; 17: 189-192Abstract Full Text PDF PubMed Scopus (138) Google Scholar], which has been widely performed in the pediatric population with aortic or pulmonary valve stenosis [9Levi D.S. Alejos J.C. Moore J.W. Future of interventional cardiology in pediatrics.Curr Opin Cardiol. 2003; 18: 79-90Crossref PubMed Scopus (13) Google Scholar, 21Masura J. Burch M. Deanfield J.E. Sullivan I.D. Five-year follow-up after balloon pulmonary valvuloplasty.J Am Coll Cardiol. 1993; 21: 132-136Abstract Full Text PDF PubMed Scopus (74) Google Scholar]. Percutaneous transseptal mitral commissurotomy has also supplanted surgical commissurotomy for most patients with rheumatic mitral stenosis and has become an excellent therapy option for many who previously had none [22Eltchaninoff H. Tron C. Cribier A. Effectiveness of percutaneous mechanical mitral commissurotomy using the metallic commissurotomy in patient with restenosis after balloon or previous surgical commissurotomy.Am J Cardiol. 2003; 91: 425-428Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar].Considering the limitations associated with an interventional approach to valvular heart disease in adults, valvuloplasty remains a viable alternative to surgery only in a subgroup of patients [22Eltchaninoff H. Tron C. Cribier A. Effectiveness of percutaneous mechanical mitral commissurotomy using the metallic commissurotomy in patient with restenosis after balloon or previous surgical commissurotomy.Am J Cardiol. 2003; 91: 425-428Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar]. Those with noncalcified mitral stenosis benefit from temporary symptomatic relief, whereas in others it is only accepted as a palliative procedure or as a bridge to valve surgery in critically ill patients with advanced aortic stenosis [3Cribier A. Eltchaninoff H. Bash A. et al.Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description.Circulation. 2002; 106: 3006-3008Crossref PubMed Scopus (2520) Google Scholar, 23Robicsek F. Harbold Jr, N.B. Daugherty H.K. et al.Balloon valvuloplasty in calcified aortic stenosis: a cause for caution and alarm.Ann Thorac Surg. 1988; 45: 515-525Abstract Full Text PDF PubMed Scopus (34) Google Scholar].Furthermore, recent percutaneous approaches to mitral valve repair include placement of a mitral annular constraint device in the coronary sinus to reduce mitral regurgitation in an experimental model of dilated cardiomyopathy [18Kaye D.M. Byrne M. Alferness C. Power J. Feasibility and short-term efficacy of percutaneous mitral annular reduction for the therapy of heart failure-induced mitral regurgitation.Circulation. 2003; 108: 1795-1797Crossref PubMed Scopus (127) Google Scholar, 24Liddicoat J.R. Mac Neill B.D. Gillinov A.M. et al.Percutaneous mitral valve repair: a feasibility study in an ovine model of acute ischemic mitral regurgitation.Catheter Cardiovasc Interv. 2003; 60: 410-416Crossref PubMed Scopus (113) Google Scholar]. In addition, St. Goar and coworkers [25St. Goar F.G. Fann J.I. Komtebedde J. et al.Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model.Circulation. 2003; 108: 1990-1993Crossref PubMed Scopus (153) Google Scholar] are successfully working on percutaneous mitral valve intervention, consisting of an expandable capture device for grasping and positioning the mitral leaflets, and a fixation instrument that clips both leaflets together (percutaneous edge-to-edge operation).In the late 90s, one of us began a series of animal studies in pursuit of successful percutaneous valve replacement [2Bonhoeffer P. Boudjemline Y. Saliba Z. et al.Transcatheter implantation of a bovine valve in pulmonary position: a lamb study.Circulation. 2000; 102: 813-816Crossref PubMed Scopus (244) Google Scholar]. The system was comprised of glutaraldehyde-treated, bovine, venous jugular valves that were sewn into a balloon expandable stent that was delivered percutaneously to the pulmonary artery of lambs (Fig 1). The valved stent was deployed in the native pulmonary valve to affect functioning of the native valve and fix the device to the pulmonary wall. Transcatheter implantation of the valved stent was successful, and the long-term study in lambs revealed stable positioning of the stent with competent valves at the end of 2 months [2Bonhoeffer P. Boudjemline Y. Saliba Z. et al.Transcatheter implantation of a bovine valve in pulmonary position: a lamb study.Circulation. 2000; 102: 813-816Crossref PubMed Scopus (244) Google Scholar]. The same stent design was later successfully implanted in the descending aorta in a group of lambs with traumatically-created massive aortic insufficiency [6Boudjemline Y. Bonhoeffer P. Steps toward percutaneous valve replacement.Circulation. 2002; 105: 775-778Crossref PubMed Scopus (143) Google Scholar]. This valve was able to normalize pressures in the distal descending aorta and remained competent. However, all experiments failed when the valved stent was positioned into the native annulus as its walls either obstructed the coronaries or interfered with the function of the mitral valve.To overcome this obstacle, a device to assure a predictable orientation and a nonobstructive position of the stent in the aortic orifices was designed. This consisted of three self-expandable nitinol hooks engineered to fit into the three aortic valve leaflets without obstructing the coronary arteries. In a series of 12 lambs we successfully transluminally implanted an optimally-functioning valved stent in 4 animals of the descending aorta group and we used a carotid approach in 1 animal in the orthotopic group. Whether such a method is also implementable in human aortic annuli due to its deployment strategy is still unknown [6Boudjemline Y. Bonhoeffer P. Steps toward percutaneous valve replacement.Circulation. 2002; 105: 775-778Crossref PubMed Scopus (143) Google Scholar].In 2000, the same group reported two studies describing the first successful percutaneous pulmonary valve replacements in man [7Bonhoeffer P. Boudjemline Y. Saliba Z. et al.Percutaneous replacement of a pulmonary valve in a right ventricle to pulmonary artery conduit.Lancet. 2000; 356: 1403-1405Abstract Full Text Full Text PDF PubMed Scopus (799) Google Scholar, 8Bonhoeffer P. Boudjemline Y. Qureshi S. et al.Percutaneous insertion of the pulmonary valve.J Am Coll Cardiol. 2002; 39: 1664-1669Abstract Full Text Full Text PDF PubMed Scopus (272) Google Scholar] in which 8 patients with a failing artificial pulmonary outflow tract received bovine jugular-vein valve (Venpro Corp, Irvine, CA) fitted in a platinum stent (Numed Inc, Hopkinton, NY). The current clinical experience of 56 patients (median age, 16 years, range, 9 to 41), including this early series, confirms a 98% freedom from pulmonary regurgitation at median follow-up of 4 months (range, 2 weeks to 36 months) with zero mortality (Fig 2). Procedural complications requiring emergency surgery have occurred in 3 patients, 2 due to embolization of the valved stent and 1 due to homograft rupture (personal communication). The predominant indication remains homograft–conduit stenosis with or without valvular regurgitation due to limitation of device size. The recent development of an infundibular reducing device in animals [26Boudjemline Y. Agnoletti G. Bonnet D. Sidi D. Bonhoeffer P. Percutaneous pulmonary valve replacement in a large right ventricular outflow tract: an experimental study.J Am Coll Cardiol. 2004; 43: 1082-1087Abstract Full Text Full Text PDF PubMed Scopus (105) Google Scholar] is a promising advance for those patients with dilated right ventricular outflow tracts who are currently unsuitable for this technology.Fig 2Pulmonary angiogram of valvular competence of a newly implanted valve after percutaneous delivery in the last series of Bonhoeffer and colleagues.View Large Image Figure ViewerDownload (PPT)Doctor Lutter [10Lutter G, v Samson P, Kuklinski D, et al. A new percutaneous transluminal technique for minimal aortic valve replacement. Circulation 2001;104:II-552.Google Scholar] and his group began performing in vivo studies to implant aortic valved stents in the mid 1990s and reported the results of their first successful animal studies in 2001. A percutaneous stent-based expandable valve was designed by mounting a porcine aortic valve taken from freshly slaughtered pigs into a self-expandable nitinol stent by means of a suture technique (Fig 3). Before implantation in vivo, valved stents were tested in a mock cir" @default.
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- W2065647698 title "Percutaneous Valve Replacement: Current State and Future Prospects" @default.
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