Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: Early results of the feasibility trial

European Heart Journal

Volumn 37, Issue 10, 2016, Pages 817-825

  Maisano, Francesco ^a   Taramasso, Maurizio ^a   Nickenig, Georg ^b   Hammerstingl, Christoph ^b   Vahanian, Alec ^c   Messika Zeitoun, David ^c   Baldus, Stephan ^d   Huntgeburth, Michael ^d   Alfieri, Ottavio ^e   Colombo, Antonio ^e   La Canna, Giovanni ^e   Agricola, Eustachio ^e   Zuber, Michel ^a   Tanner, Felix C ^a   Topilsky, Yan ^f   Kreidel, Felix ^g   Kuck, Karl Heinz ^g  

^a UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^b UNIVERSITY HOSPITAL BONN   (Germany)

^c BICHAT HOSPITAL   (France)

^d UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^e SAN RAFFAELE HOSPITAL   (Italy)

^f TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

^g DEPARTMENT OF CARDIOLOGY   (Germany)

Author keywords

Direct annuloplasty; Secondary mitral regurgitation; Transcatheter mitral repair

Indexed keywords

ANTICOAGULANT AGENT;

AGED; ANNULOPLASTY RING; ANTICOAGULANT THERAPY; ARTICLE; ATRIAL FIBRILLATION; BRAIN HEMORRHAGE; CLINICAL ARTICLE; DEVICE SAFETY; DYSPNEA; FALSE ANEURYSM; FEASIBILITY STUDY; FEMALE; FLUOROSCOPY; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HEMIPARESIS; HIGH RISK PATIENT; HOSPITAL DISCHARGE; HOSPITALIZATION; HUMAN; KIDNEY FAILURE; LENGTH OF STAY; MALE; MITRAL ANNULOPLASTY; MITRAL VALVE REGURGITATION; MITRAL VALVE REPLACEMENT; MULTICENTER STUDY; MULTIPLE ORGAN FAILURE; PERICARDIAL EFFUSION; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROSTHESIS FAILURE; RECURRENT DISEASE; SURGICAL MORTALITY; THREE DIMENSIONAL ECHOCARDIOGRAPHY; TRANSESOPHAGEAL ECHOCARDIOGRAPHY; TRICUSPID ANNULOPLASTY; UNSPECIFIED SIDE EFFECT; CLINICAL TRIAL; HEART CATHETERIZATION; HEART VALVE PROSTHESIS; HOSPITAL MORTALITY; MITRAL VALVE INSUFFICIENCY; MORTALITY; PATIENT SAFETY; PEROPERATIVE CARE; PROCEDURES; PROSTHESIS DESIGN; TREATMENT OUTCOME;

AGED; CARDIAC CATHETERIZATION; FEASIBILITY STUDIES; FEMALE; HEART VALVE PROSTHESIS; HOSPITAL MORTALITY; HUMANS; INTRAOPERATIVE CARE; MALE; MITRAL VALVE ANNULOPLASTY; MITRAL VALVE INSUFFICIENCY; PATIENT SAFETY; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; TREATMENT OUTCOME;

EID: 84962191189     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehv603     Document Type: Article

References (28)

1. Maisano F, Alfieri O, Banai S, Buchbinder M, Colombo A, Falk V, Feldman T, Franzen O, Herrmann H, Kar S, Kuck KH, Lutter G, Mack M, Nickenig G, Piazza N, Reisman M, Ruiz CE, Schofer J, Sondergaard L, Stone GW, Taramasso M, Thomas M, Vahanian A,Webb J, Windecker S, Leon MB. The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement? Eur Heart J 2015;36:1651-1659.
2. Lancellotti P, Tribouilloy C, Hagendorff A, Popescu BA, Edvardsen T, Pierard LA, Badano L, Zamorano JL. Recommendations for the echocardiographic assessment of native valvular regurgitation: an executive summary from the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging 2013;14:611-644.
3. Grigioni F, Enriquez-Sarano M, Zehr KJ, Bailey KR, Tajik AJ. Ischemic mitral regurgitation: long-term outcome and prognostic implications with quantitative Doppler assessment. Circulation 2001;103:1759-1764.
4. Acker MA, Bolling S, Shemin R, Kirklin J, Oh JK, Mann DL, Jessup M, Sabbah HN, Starling RC, Kubo SH. Mitral valve surgery in heart failure: insights from the Acorn Clinical Trial. J Thorac Cardiovasc Surg 2006;132:568-577, 577.e1-4.
5. De Bonis M, Taramasso M, Grimaldi A, Maisano F, Calabrese MC, Verzini A, Ferrara D, Alfieri O. The GeoForm annuloplasty ring for the surgical treatment of functional mitral regurgitation in advanced dilated cardiomyopathy. Eur J Cardio-Thorac Surg 2011;40:488-495.
6. Bolling SF, Deeb GM, Brunsting LA, Bach DS. Early outcome of mitral valve reconstruction in patients with end-stage cardiomyopathy. J Thorac Cardiovasc Surg 1995; 109:676-682; discussion 682-3.
7. Silberman S, Klutstein MW, Sabag T, Oren A, Fink D, Merin O, Bitran D. Repair of ischemic mitral regurgitation: comparison between flexible and rigid annuloplasty rings. Ann Thorac Surg 2009;87:1721-1726; discussion 1726-7.
8. Bax JJ, Braun J, Somer ST, Klautz R, Holman ER, Versteegh MI, Boersma E, Schalij MJ, van derWall EE, Dion RA. Restrictive annuloplasty and coronary revascularization in ischemic mitral regurgitation results in reverse left ventricular remodeling. Circulation 2004;110(Suppl. 1):Ii103-Ii108.
9. Mihaljevic T, Lam BK, Rajeswaran J, Takagaki M, Lauer MS, Gillinov AM, Blackstone EH, Lytle BW. Impact of mitral valve annuloplasty combined with revascularization in patients with functional ischemic mitral regurgitation. J Am Coll Cardiol 2007;49:2191-2201.
10. 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.
11. Mirabel M, Iung B, Baron G, Messika-Zeitoun D, Detaint D, Vanoverschelde JL, Butchart EG, Ravaud P, Vahanian A. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J 2007; 28:1358-1365.
12. Beeri R, Yosefy C, Guerrero JL, Abedat S, Handschumacher MD, Stroud RE, Sullivan S, Chaput M, Gilon D, Vlahakes GJ, Spinale FG, Hajjar RJ, Levine RA. Early repair of moderate ischemic mitral regurgitation reverses left ventricular remodeling: A functional and molecular study. Circulation 2007;116(11 Suppl):I288-I293.
13. Maisano F, Vanermen H, Seeburger J, Mack M, Falk V, Denti P, Taramasso M, Alfieri O. Direct access transcatheter mitral annuloplasty with a sutureless and adjustable device: preclinical experience. Eur J Cardio-Thorac Surg 2012;42:524-529.
14. Alfieri O, Taramasso M, Denti P, Cioni M, Blasio A, Buzzatti N, La Canna G, Maisano F. Initial clinical experience with the Cardioband system: direct access mitral annuloplasty with a sutureless and adjustable device. In EACTS Annual Meeting 2012, 2012.
15. Maisano F, La Canna G, Latib A, Denti P, Taramasso M, Kuck KH, Colombo A, Alfieri O, Guidotti A, Messika-Zeitoun D, Vahanian A. First-in-man transseptal implantation of a 'surgical-like' mitral valve annuloplasty device for functional mitral regurgitation. JACC Cardiovasc Interv 2014;7:1326-1328.
16. Feldman T, Wasserman HS, Herrmann HC, Gray W, Block PC, Whitlow P, 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.
17. Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN trial. Eur J Heart Fail 2012;14:931-938.
18. Ledwoch J, Franke J, Baldus S, SchillingerW, Bekeredjian R, Boekstegers P, Hink U, Kuck KH, Ouarrak T, Mollmann H, Nickenig G, Senges J, Franzen O, Sievert H. Impact of the learning curve on outcome after transcatheter mitral valve repair: results from the German Mitral Valve Registry. Clin Res Cardiol 2014;103:930-937.
19. Sundermann SH, Gordic S, Manka R, Cesarovic N, Falk V, Maisano F, Alkadhi H. Computed tomography for planning and postoperative imaging of transvenous mitral annuloplasty: first experience in an animal model. Int J Cardiovasc Imaging 2015; 31:135-142.
20. Glower DD, Kar S, Trento A, Lim DS, Bajwa T, Quesada R, Whitlow PL, Rinaldi MJ, Grayburn P, Mack MJ, Mauri L, McCarthy PM, Feldman T. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol 2014;64:172-181.
21. Maisano F, Franzen O, Baldus S, Schafer U, Hausleiter J, Butter C, Ussia GP, Sievert H, Richardt G, Widder JD, Moccetti T, Schillinger W. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol 2013;62:1052-1061.
22. Kwon MH, Lee LS, Cevasco M, Couper GS, Shekar PS, Cohn LH, Chen FY. Recurrence of mitral regurgitation after partial versus complete mitral valve ring annuloplasty for functional mitral regurgitation. J Thorac Cardiovasc Surg 2013;146: 616-622.
23. Wong VM,Wenk JF, Zhang Z, Cheng G, Acevedo-Bolton G, Burger M, Saloner DA, Wallace AW, Guccione JM, Ratcliffe MB, Ge L. The effect of mitral annuloplasty shape in ischemic mitral regurgitation: A finite element simulation. Ann Thorac Surg 2012;93:776-782.
24. Schillinger W, Hunlich M, Baldus S, Ouarrak T, Boekstegers P, Hink U, Butter C, Bekeredjian R, Plicht B, Sievert H, Schofer J, Senges J, Meinertz T, Hasenfuss G. Acute outcomes after MitraClip therapy in highly aged patients: results from the German TRAnscatheter Mitral valve Interventions (TRAMI) registry. EuroIntervention 2013;9:84-90.
25. Taramasso M, Maisano F, Latib A, Denti P, Buzzatti N, Cioni M, La Canna G, Colombo A, Alfieri O. Clinical outcomes of MitraClip for the treatment of functional mitral regurgitation. EuroIntervention 2014;10:746-752.
26. Maisano F, Caldarola A, Blasio A, De Bonis M, La Canna G, Alfieri O. Midterm results of edge-to-edge mitral valve repair without annuloplasty. J Thorac Cardiovasc Surg 2003;126:1987-1997.
27. De Bonis M, Lapenna E, Maisano F, Barili F, La Canna G, Buzzatti N, Pappalardo F, Calabrese M, Nisi T, Alfieri O. Long-term results (=18 years) of the edge-to-edge mitral valve repair without annuloplasty in degenerative mitral regurgitation: implications for the percutaneous approach. Circulation 2014; 130(11 Suppl 1):S19-S24.
28. Grayburn PA, Roberts BJ, Aston S, Anwar A, Hebeler RF Jr, Brown DL, Mack MJ. Mechanism and severity of mitral regurgitation by transesophageal echocardiography in patients referred for percutaneous valve repair. Am J Cardiol 2011;108: 882-887.