Prospects for percutaneous valve therapies

Circulation

Volumn 116, Issue 24, 2007, Pages 2866-2877

  Feldman, Ted ^a   Leon, Martin B ^b  

^a EVANSTON HOSPITAL   (United States)

^b NewYork Presbyterian Hospital   (United States)

Author keywords

Aortic stenosis; Aortic valve; Mitral regurgitation; Mitral valve

Indexed keywords

ANNULOPLASTY; AORTA VALVE DISEASE; AORTA VALVE REPLACEMENT; BIOPROSTHESIS; CLINICAL TRIAL; CORONARY ARTERY BYPASS SURGERY; GRAFT FAILURE; HEALTH SURVEY; HEMODYNAMICS; HUMAN; MITRAL ANNULOPLASTY; MITRAL VALVE REGURGITATION; NONHUMAN; PREOPERATIVE EVALUATION; PRIORITY JOURNAL; PROGNOSIS; REVIEW; SAFETY; SURGICAL TECHNIQUE; TRANSLUMINAL VALVULOPLASTY; TREATMENT OUTCOME; VALVULAR HEART DISEASE;

CATHETER ABLATION; CLINICAL TRIALS AS TOPIC; HEALTH SURVEYS; HEART VALVE DISEASES; HUMANS; PULMONARY VALVE; STENTS;

EID: 37349106370     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.106.621375     Document Type: Review

References (73)

1. Pavcnik D. Wright KC. Wallace S. Development and initial experimental evaluation of a prosthetic aortic valve for transcatheter placement. Work in progress. Radiology. 1992;183:151-154.
2. Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed-chest pigs. Eur Heart J. 1992;13:704-708.
3. Alfieri O, Maisano F, Colombo A. Future of transcatheter repair of the mitral valve. Amer J Cardiol. 2005;96:71-75.
4. Liddicoat JR, MacNeill BD, Gillinov AM, Cohn WE, Chin CH, Prado AD, Pandian NG, Oesterle SN. Percutaneous mitral valve repair: a feasibility study in an ovine model of acute ischemic mitral regurgitation. Catheter Cardiovasc Interv. 2003;60:410-416.
5. Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: the Euro Heart Survery on Valvular Heart Disease. Eur Heart J. 2003;24:1231-1243.
6. Varadarajan P, Kapoor N, Bansal RC, Pai RG. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg. 2006;82:2111-2115.
7. Bando K, Danielson GK, Schaff HV, Mair DD, Julsrud PR, Puga FJ. Outcome of pulmonary and aortic homografts for right ventricular outflow tract reconstruction. J Thorac Cardiovasc Surg. 1995;109: 509-519.
8. Sugiyama H, Williams W, Benson LN. Implantation of endovascular stents for the obstructive right ventricular outlow tract. Heart. 2005;91: 1058-1063.
9. Bonhoeffer P, Boudjemline Y, Saliba Z, Merckx J, Aggoun Y, Bonnet D, Acar P, Le Bidois J, Sidi D, Kachaner J. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet. 2000;356:1403-1405.
10. Coats L, Khambadkone S, Derrick G, Sridharan S, Schievano S, Mist B, Jones R, Deanfield JE, Pellerin D, Bonhoeffer P. Taylor AM. Physiological and clinical consequences of relief of right ventricular outflow tract obstruction late after repair of congenital heart defects. Circulation. 2006;113:2037-2044.
11. Khambadkone S, Coats L, Taylor A, Boudjemline Y, Derrick G, Tsang V, Cooper J, Muthurangu V, Hegde SR, Razavi RS, Pellerin D, Deanfield J, Bonhoeffer P. Percutaneous pulmonary valve implantation in humans: results in 59 consecutive patients. Circulation. 2005;112:1189-1197.
12. Bonow O, Carabello B, Chaterjee K, DeLeon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise J. ACC/AHA 2006 Guidelines for the Management of Patients with Valvular Heart Disease. Executive Summary. Circulation. 2006;114:450-527.
13. Schwarz F, Baumann P, Manthey J, Hoffmann M, Schuler G, Mehmel HC, Schmitz W, Kubler W. The effects of aortic valve replacement on survival. Circulation. 1982;66:1105-1110.
14. Smith N, McAnulty JH, Rahimtoola SH. Severe aortic stenosis with impaired left ventricular function and clinical hear failure: results of valve replacement. Circulation. 1978;58:255-264.
15. Kvidal P, Bergstrom R, Horte LG, Stahle E. Observed and relative survival after aortic valve replacement. J Am Coll Cardiol. 2000;35: 747-756.
16. Edwards FH, Peterson ED, Coombs LP, DeLong ER, Jamieson WR, Shroyer ALW, Grover FL. Prediction of operative mortality after valve replacement surgery. J Am Coll Cardiol. 2001;37:885-892.
17. Society of Thoracic Surgeons National Cardiac Surgery Database. Available at: http://www.sts.org/documents/pdf/Spring2005STSExecutiveSummary.pdf. Accessed November 2005.
18. Birkmeyer JD, Siewers AE, Finlayson EV, Stukel TA, Lucas FL, Batista I, Welch HG, Wennberg DE. Hospital volume and surgical mortality in the United States. N Engl J Med. 2002;346:1128-1137.
19. Goodney PP, O'Connor GT, Wennberg DE, Birkmeyer JD. Do hospitals with low mortality rates in coronary artery bypass also perform well in valve replacement? Ann Thorac Surg. 2003;76:1131-1136.
20. Levinson JR, Akins CW, Buckley MJ, Newell JB, Palacios IF, Block PC, Fifer MA. Octogenarians with aortic stenosis. Outcome after aortic valve replacement. Circulation. 1989;80:I49-I56.
21. Kolh P, Kerzmann A, Lahaye L, Gerard P, Limet R. Cardiac surgery in octogenarians; peri-operative outcome and long-term results. Eur Heart J. 2001;22:1235-1243.
22. Powell DE, Tunick PA, Rosenzweig BP, Freedberg RS, Katz ES, Applebaum RM, Perez JL, Kronzon I. Aortic valve replacement in patients with aortic stenosis and severe left ventricular dysfunction. Arch Intern Med. 2000;160:1337-1341.
23. Connolly HM, Oh JK, Schaff HV, Roger VL, Osborn SL, Hodge DO, Tajik AJ. Severe aortic stenosis with low transvalvular gradient and severe left ventricular dysfunction: result of aortic valve replacement in 52 patients. Circulation. 2000;101:1940-1946.
24. Pereira JJ, Lauer MS, Bashir M, Afridi I, Blackstone EH, Stewart WJ, McCarthy PM, Thomas JD, Asher CR. Survival after aortic valve replacement for severe aortic stenosis with low transvalvular gradients and severe left ventricular dysfunction. J Am Coll Cardiol. 2002;39: 1356-1363.
25. Goodney PP, Stukel TA, Lucas FL, Finlayson EV, Birkmeyer JD. Hospital volume, length of stay, and readmission rates in high-risk surgery. Ann Surg. 2003;238:161-167.
26. Sundt TM, Bailey MS, Moon MR, Mendeloff EN, Huddleston CB, Pasque MK, Barner HB, Gay WA Jr. Quality of life after aortic valve replacement at the age of >80 years. Circulation. 2000;102:III70-III74.
27. Zimpfer D, Czerny M, Kilo J, Kasimir MT, Madl C, Kramer L, Wieselthaler GM, Wolner E, Grimm M. Cognitive deficit after aortic valve replacement. Ann Thorac Surg. 2002;74:407-412.
28. Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106:3006-3008.
29. Eltchaninoff H, Tron C, and Cribier A. Percutaneous implantation of aortic valve prosthesis in patients with calcific aortic stenosis: technical aspects. J Interv Cardiol. 2003;16:515-521.
30. Webb JG, Chandavimol M, Thompson CR, Ricci DR, Carere RG, Munt BI, Buller CE, Pasupati S, Lichtenstein S. Percutaneous aortic valve implantation retrograde from the femoral artery. Circulation. 2006;113: 842-850.
31. Lichtenstein SV, Cheung A, Ye J, Thompson CR, Carere RG, Pasupati S, Webb JG. Transapical transcatheter aortic valve implantation in humans: initial clinical experience. Circulation. 2006;114:591-596.
32. Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Nercolini D, Tapiero S, Litzler PY, Bessou JP, Babaliaros V. Treatment of calcific aortic stenosis with the percutaneous heart valve. Mid-term follow-up from the initial feasibility studies: the French experience. J Am Coll Cardiol. 2006;47:1214-1223.
33. Kodali, SK, O'Neill W, Moses JW, Kapadia S, Williams M, Hanzel G, Stewart A, Tuzcu ME, Collins M, Leon MB. Preliminary Results from the PeRcutaneous EndoVascular Implantation of VALves Trial in High Risk Patients with Critical Aortic Stenosis. Am J Cardiol. 2006; 98(suppl 1);48M.
34. Laborde JC, Borenstein N, Behr L, Farah B, Fajadet J. Percutaneous implantation of the Corevalve aortic valve prosthesis for patients presenting high risk for surgical valve replacement. Eurointervention. 2006; 1:472-474.
35. Grube E, Laborde JC, Zickmann B, Gerckens U, Felderhoff T, Sauren B, Bootsveld A, Buellesfeld L, Iversen S. First report on a human percutaneous transluminal implantation of a self-expanding valve prosthesis for interventional treatment of aortic valve stenosis. Catheter Cardiovasc Interv. 2005;66:465-469.
36. Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation. 2006;114:1616-1624.
37. Harris KM, Sundt TM III, Aeppli D, Sharma R, Barzilai B. Can late survival of patients with moderate ischemic mitral regurgitation be impacted by intervention on the valve? Ann Thorac Surg. 2002;74: 1468-1475.
38. Diodato MD, Moon MR, Pasque MK, Barner HB, Moazami N, Lawton JS, Bailey MS, Guthrie TJ, Meyers BF, Damiano RJ Jr. Repair of ischemic mitral regurgitation does not increase mortality or improve long-term survival in patients undergoing coronary artery revascularization: a propensity analysis. Ann Thorac Surg. 2004;78:794-799.
39. Wu AH, Aaronson KD, Bolling SF, Pagani FD, Welch K, Koelling TM. Impact of mitral valve annuloplasty on mortality risk in patients with mitral regurgitation and left ventricular systolic dysfunction. J Am Coll Cardiol. 2005;45:381-387.
40. Enomoto Y, Gorman JH 3rd, Moainie SL, Guy TS, Jackson BM, Parish LM, Plappert T, Zeeshan A, St John-Sutton MG, Gorman RC. Surgical treatment of ischemic mitral regurgitation may not influence ventricular remodeling. J Thorac Cardiovasc Surg. 2005;129:504-511.
41. Alfieri O, Elefteriades JA, Chapolini RJ, Steckel R, Allen WJ, Reed SW, Shreck S. Novel suture device for beating-heart mitral leaflet approximation. Ann Thorac Surg. 2002;74:1488-1493.
42. Alfieri O, Maisano F, DeBonis M, Stefano PL, Torracca L, Oppizzi M, LaCanna G. The edge-to-edge technique in mitral valve repair: a simple solution for complex problems. J Thorac Cardiovasc Surg. 2001;122: 674-681.
43. Bhudia SK, McCarthy PM, Smedira NG, Lam BK, Rajeswaran J, Blackstone EH. Edge-to-edge (Alfieri) mitral repair: results in diverse clinical settings. Ann Thorac Surg. 2004;77:1598-1606.
44. Kherani AR, Cheema FH, Casher J, Fal JM, Mutrie CJ, Chen JM, Morgan JA, Vigilance DW, Garrido MJ, Smith CR, Oz MC. Edge-to-edge mitral valve repair: the Columbia Presbyterian experience. Ann Thorac Surg. 2004;78:73-76.
45. Maisano F, Vigano G, Blasio A, Columbo A, Calabrese C, Alfieri O. Surgical isolated edge-to-edge mitral repair without annuloplasty- clinical proof of principle for an endovascular approach. Eurointervention. 2006; 2:181-186.
46. St Goar FG, James FI, Komtebedde J, Foster E, Oz MC, Fogarty TJ, Feldman T, Block PC. Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model. Circulation. 2003;108:1990-1993.
47. Fann JI, St Goar FG, Komtebedde J, Oz MC, Block PC, Foster E, Feldman T, Burdon TA. Off-pump edge-to-edge mitral valve technique using a mechanical clip in a chronic model. Circulation. 2003;108(supp IV):493. Abstract.
48. St Goar FG, Fann JI, Feldman TE, Block PC, Herrmann HC. Percutaneous mitral valve repair with the edge-to-edge technique. In: Herrman HC, ed. Contemporary Cardiology: Interventional Cardiology-Percutaneous Noncoronary Intervention. Totowa, NJ. Humana Press; 2005:87-95.
49. Herrmann HC, Feldman T. Percutaneous mitral valve edge-to-edge repair with the Evalve Mitraclip system: rationale and phase I results. EuroIntervention. 2006;1(suppl A):A36-A39.
50. Feldman T, Alfieri O, St Goar F: Percutaneous leaflet repair for mitral regurgitation using the Evalve edge-to-edge clip technique. In: Hijazi Z, Bonhoeffoer P, Feldman T, Ruiz C, Martin Dunitz, eds. Transcatheter Valve Repair. London, United Kingdom. Parthenon Publishing/Taylor & Francis Medical Books; 2006:275-284.
51. Feldman T, Wasserman HS, Herrmann HC, Gray W, Block PC, Whiltlow PL, St Goar F, Rodriguez L, Silvestry F, Schwartz A, Sanborn TA, Condado JA, Foster E. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST phase I clinical trial. J Am Coll Cardiol. 2005;46:2134-2140.
52. Feldman T, Wasserman HS, Herrmann HC, Whitlow PL, Block PC, Gray WA, Foster E, St Goar F: Edge-to-edge mitral valve repair using the Evalve MitraClip: One year results of the EVEREST phase I clinical trial. Am J Cardiol. 2005;96(supp):49H.
53. Zoghbi WA, Enriquez-Sarano M, Foster E, Grayburn PA, Kraft CD, Levine RA, Nihoyannopoulos P, Otto CM, Quinones MA, Rakowski H, Stewart WJ, Waggoner A, Weissman NJ. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr. 2003;16:777-802.
54. Dang NC, Aboodi MS, Sakaguchi T, Wasserman HS, Argenziano M, Cosgrove DM, Rosengart TK, Feldman T, Block PC, Oz MC. Surgical revision after percutaneous mitral valve repair with a clip: initial multicenter experience. Ann Thorac Surg. 2005;80:2338-2342.
55. Yamanouchi Y, Igawa O, Hisatome I. Activation mapping from the coronary sinus may be limited by anatomic variations. Pacing Clin Electrophysiol. 1998;21:2522-2526.
56. Webb JG, Harnek J, Munt BI, Kimblad PO, Chandavimol M, Thompson CR, Solem JO. Percutaneous transvenous mitral annuloplasty; initial human experience with device implantation in the coronary sinus. Circulation. 2006;113:851-855.
57. Kaye DM, 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;108:1795-1797.
58. Maniu CV, Patel JB, Reuter DG, Meyer DM, Edwards WD, Rihal CS, Redfield MM. Acute and chronic reduction of functional mitral regurgitation in experimental heart failure by percutaneous mitral annuloplasty. J Am Coll Cardiol. 2004;44:1652-1661.
59. Byrne MJ, Kaye DM, Mathis M, Reuter DG, Alferness CA, Power JM. Percutaneous mitral annular reduction provides continued benefit in an ovine model of dilated cardiomyopathy. Circulation. 2004;110: 3088-3092.
60. Liddicoat JR, MacNeill BD, Gillinov AM, Cohn WE, Chin CH, Prado AD, Pandian NG, Oesterle SN. Percutaneous mitral valve repair: a feasibility study in an ovine model of acute ischemic mitral regurgitation. Catheter Cardiovasc Interv. 2003;60:410-416.
61. Rogers JH, Macoviak JA, Rahdert DA, Takeda PA, Palacios IF, Low RI. Percutaneous septal sinus shortening: a novel procedure for the treatment of functional mitral regurgitation. Circulation. 2006;113:2329-2334.
62. Maselli D, Guarracino F, Chiaramonti F, Mangia F, Borelli G, Minzioni G. Percutaneous mitral annuloplasty: an anatomic study of human coronary sinus and its relation with mitral valve annulus and coronary arteries. Circulation. 2006;114:377-380.
63. Tibayan FA, Rodriguez F, Liang D, Daughters GT Ingels NB Jr, Miller DC. Paneth suture annuloplasty abolishes acute ischemic mitral regurgitation but preserves annular and leaflet dynamics. Circulation. 2003; 108(suppl 1):II-128-II-33.
64. Burr LH, Krayenbuhl C, Sutton MS. The mitral plication suture: a new technique of mitral valve repair. J Thorac Cardiovasc Surg. 1977;73: 589-595.
65. Nagy ZL, Bodi A, Vazily M, Szerafin T, Horvath A, Peterffy A. Five-year experience with a suture annuloplasty for mitral valve repair. Scand Cardiovasc J. 2000;34:528-532.
66. Aybek T, Risteski P, Miskovic A, Simon A, Dogan S, Abdel-Rahman U, Moritz A. Seven years' experience with suture anuloplasty for mitral valve repair. J Thorac Cardiovasc Surg. 2006;101:99-106.
67. Grossi EA, Saunders PC, Woo J, Gangahar DM, Laschinger JC, Kress DC, Caskey MP, Schwartz CF, Wudel J. Intraoperative effects of the Coapsys annuloplasty system in a randomized evaluation (RESTOR-MV) of functional ischemic mitral regurgitation. Ann Thorac Surg. 2005;80: 1706-1711.
68. Pedersen WR, Block P, Feldman T. The iCoapsys repair system for the percutaneous treatment of functional mitral insufficiency. Eurointervention. 2006;1(suppl A):A44-A48.
69. Vassiliades TA Jr, Block PC, Cohn LH, Adams DH, Borer JS, Feldman T, Holmes DR, Laskey WK, Lytle BW, Mack MJ, Williams DO. The clinical development of percutaneous heart valve technology: an interdisciplinary position statement. The Society of Thoracic Surgeons (STS), The American Association for Thoracic Surgery (AATS), The American College of Cardiology (ACC), and The Society of Cardiovascular Angiography and Intervention (SCAI). J Am Coll Cardiol. 2005;49: 1554-1560.
70. Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005; 352:9:875-883.
71. Rosenhek R, Rader F, Klaar U, Gabriel H, Krejc M, Kalbeck D, Schemper M, Maurer G, Baumgartner H. Outcome of watchful waiting in asymptomatic severe mitral regurgitation. Circulation. 2006;113: 2238-2244.
72. Messas E, Bel A, Cortes Morichetti M, Carrion C, Handschumacher MD, Peyrard S, Vilquin JT, Desnos M, Bruneval P, Carpentier A, Menasché P, Levine RA, Hagège AA. Autologous myoblast transplantation for chronic ischemic mitral regurgitation. J Am Coll Cardiol. 2006;47:2086-2093.
73. Feldman T. Percutaneous valve repair and replacement: challenges encountered, challenges met, challenges ahead. Circulation. 2006;113: 771-772.