Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves

Circulation: Cardiovascular Interventions

Volumn 8, Issue 10, 2015, Pages

  Binder, Ronald K ^a   Stortecky, Stefan ^b   Heg, Dik ^c   Tueller, David ^d   Jeger, Raban ^e   Toggweiler, Stefan ^f   Pedrazzini, Giovanni ^g   Amann, Franz W ^h   Ferrari, Enrico ⁱ   Noble, Stephane ^j   Nietlispach, Fabian ^a   Maisano, Francesco ^a   Raber, Lorenz ^b   Roffi, Marco ^j   Grunenfelder, Jurg ^h   Juni, Peter ^c   Huber, Christoph ^b   Windecker, Stephan ^b   Wenaweser, Peter ^b  

^a UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^b BERN UNIVERSITY HOSPITAL   (Switzerland)

^c UNIVERSITY OF BERN   (Switzerland)

^d TRIEMLI HOSPITAL   (Switzerland)

^e UNIVERSITY HOSPITAL BASEL   (Switzerland)

^f LUZERNER KANTONSSPITAL   (Switzerland)

^g DIVISION OF CARDIOLOGY   (Switzerland)

^h KLINIK HIRSLANDEN   (Switzerland)

ⁱ LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^j GENEVA UNIVERSITY HOSPITALS   (Switzerland)

more..

Author keywords

Aortic valve stenosis; bleeding; transcatheter aortic valve replacement; transcatheter heart valve; transcutaneous aortic valve implantation; vascular complications

Indexed keywords

ANTICOAGULANT AGENT; CONTRAST MEDIUM;

AGED; AORTA STENOSIS; ARTICLE; ARTIFICIAL HEART PACEMAKER; ATRIOVENTRICULAR CONDUCTION; CEREBROVASCULAR ACCIDENT; COHORT ANALYSIS; DISEASE SEVERITY; DYSLIPIDEMIA; FEMALE; GENERAL ANESTHESIA; HEART CATHETERIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MITRAL VALVE REGURGITATION; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PACEMAKER IMPLANTATION; PRIORITY JOURNAL; RISK REDUCTION; SWITZERLAND; TRANSCATHETER AORTIC VALVE IMPLANTATION; VERY ELDERLY; ADVERSE EFFECTS; AORTA VALVE; AORTIC VALVE STENOSIS; CLINICAL TRIAL; HEART VALVE PROSTHESIS; MULTICENTER STUDY; POSTOPERATIVE COMPLICATIONS; PROSPECTIVE STUDY; RISK; TREATMENT OUTCOME; UTILIZATION;

AGED; AGED, 80 AND OVER; AORTIC VALVE; AORTIC VALVE STENOSIS; COHORT STUDIES; FEMALE; HEART VALVE PROSTHESIS; HUMANS; MALE; POSTOPERATIVE COMPLICATIONS; PROSPECTIVE STUDIES; RISK; SWITZERLAND; TRANSCATHETER AORTIC VALVE REPLACEMENT; TREATMENT OUTCOME;

EID: 84945949219     PISSN: 19417640     EISSN: 19417632     Source Type: Journal    
DOI: 10.1161/CIRCINTERVENTIONS.115.002653     Document Type: Article

References (37)

1. 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.
2. 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. doi: 10.1161/CIRCULATIONAHA.105.582882.
3. Webb JG, Binder RK. Transcatheter aortic valve implantation: the evolution of prostheses, delivery systems and approaches. Arch Cardiovasc Dis. 2012;105:153-159. doi: 10.1016/j.acvd.2012.02.001.
4. Barbanti M, Binder RK, Freeman M, Wood DA, Leipsic J, Cheung A, Ye J, Tan J, Toggweiler S, Yang TH, Dvir D, Maryniak K, Lauck S, Webb JG. Impact of low-profile sheaths on vascular complications during transfemoral transcatheter aortic valve replacement. EuroIntervention. 2013;9:929-935. doi: 10.4244/EIJV9I8A156.
5. Willson AB, Webb JG, Labounty TM, Achenbach S, Moss R, Wheeler M, Thompson C, Min JK, Gurvitch R, Norgaard BL, Hague CJ, Toggweiler S, Binder R, Freeman M, Poulter R, Poulsen S, Wood DA, Leipsic J. 3-dimensional aortic annular assessment by multidetector computed tomography predicts moderate or severe paravalvular regurgitation after transcatheter aortic valve replacement: a multicenter retrospective analysis. J Am Coll Cardiol. 2012;59:1287-1294. doi: 10.1016/j.jacc.2011.12.015.
6. Binder RK, Leipsic J, Wood D, Moore T, Toggweiler S, Willson A, Gurvitch R, Freeman M, Webb JG. Prediction of optimal deployment projection for transcatheter aortic valve replacement: angiographic 3-dimensional reconstruction of the aortic root versus multidetector computed tomography. Circ Cardiovasc Interv. 2012;5:247-252. doi: 10.1161/CIRCINTERVENTIONS.111.966531.
7. Binder RK, Webb JG, Willson AB, Urena M, Hansson NC, Norgaard BL, Pibarot P, Barbanti M, Larose E, Freeman M, Dumont E, Thompson C, Wheeler M, Moss RR, Yang TH, Pasian S, Hague CJ, Nguyen G, Raju R, Toggweiler S, Min JK, Wood DA, Rodés-Cabau J, Leipsic J. The impact of integration of a multidetector computed tomography annulus area sizing algorithm on outcomes of transcatheter aortic valve replacement: a prospective, multicenter, controlled trial. J Am Coll Cardiol. 2013;62:431-438. doi: 10.1016/j.jacc.2013.04.036.
8. Binder RK, Rodés-Cabau J, Wood DA, Webb JG. Edwards SAPIEN 3 valve. EuroIntervention. 2012;8(suppl Q):Q83-Q87. doi: 10.4244/EIJV8SQA15.
9. Linke A, Wenaweser P, Gerckens U, Tamburino C, Bosmans J, Bleiziffer S, Blackman D, Schäfer U, Müller R, Sievert H, Søndergaard L, Klugmann S, Hoffmann R, Tchétché D, Colombo A, Legrand VM, Bedogni F, lePrince P, Schuler G, Mazzitelli D, Eftychiou C, Frerker C, Boekstegers P, Windecker S, Mohr FW, Woitek F, Lange R, Bauernschmitt R, Brecker S; ADVANCE study Investigators. Treatment of aortic stenosis with a selfexpanding transcatheter valve: the International Multi-centre ADVANCE Study. Eur Heart J. 2014;35:2672-2684. doi: 10.1093/eurheartj/ehu162.
10. Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Colombo A, Lange R, Schwarz RR, Wendler O. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011;124:425-433. doi: 10.1161/CIRCULATIONAHA.110.001545.
11. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597-1607. doi: 10.1056/NEJMoa1008232.
12. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-2198. doi: 10.1056/NEJMoa1103510.
13. Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370:1790-1798. doi: 10.1056/NEJMoa1400590.
14. Binder RK, Rodés-Cabau J, Wood DA, Mok M, Leipsic J, De Larochellière R, Toggweiler S, Dumont E, Freeman M, Willson AB, Webb JG. Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve. JACC Cardiovasc Interv. 2013;6:293-300. doi: 10.1016/j.jcin.2012.09.019.
15. Amat-Santos IJ, Dahou A, Webb J, Dvir D, Dumesnil JG, Allende R, Ribeiro HB, Urena M, Paradis JM, DeLarochellière R, Dumont E, Bergeron S, Thompson CR, Pasian S, Bilodeau S, Leipsic J, Larose E, Pibarot P, Rodés-Cabau J. Comparison of hemodynamic performance of the balloon-expandable SAPIEN 3 versus SAPIEN XT transcatheter valve. Am J Cardiol. 2014;114:1075-1082. doi: 10.1016/j.amjcard.2014.07.019.
16. Murray MI, Geis N, Pleger ST, Kallenbach K, Katus HA, Bekeredjian R, Chorianopoulos E. First experience with the new generation Edwards Sapien 3 aortic bioprosthesis: procedural results and short term outcome. J Interv Cardiol. 2015;28:109-116. doi: 10.1111/joic.12182.
17. Wenaweser P, Stortecky S, Heg D, Tueller D, Nietlispach F, Falk V, Pedrazzini G, Jeger R, Reuthebuch O, Carrel T, Räber L, Amann FW, Ferrari E, Toggweiler S, Noble S, Roffi M, Gruenenfelder J, Jüni P, Windecker S, Huber C. Short-term clinical outcomes among patients undergoing transcatheter aortic valve implantation in Switzerland: the Swiss TAVI registry. EuroIntervention. 2014;10:982-989. doi: 10.4244/EIJV10I8A166.
18. Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012;60:1438-1454. doi: 10.1016/j.jacc.2012.09.001.
19. Wenaweser P, Stortecky S, Schwander S, Heg D, Huber C, Pilgrim T, Gloekler S, O'Sullivan CJ, Meier B, Jüni P, Carrel T, Windecker S. Clinical outcomes of patients with estimated low or intermediate surgical risk undergoing transcatheter aortic valve implantation. Eur Heart J. 2013;34:1894-1905. doi: 10.1093/eurheartj/eht086.
20. Généreux P, Head SJ, Hahn R, Daneault B, Kodali S, Williams MR, van Mieghem NM, Alu MC, Serruys PW, Kappetein AP, Leon MB. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles' heel? A comprehensive review of the literature. J Am Coll Cardiol. 2013;61:1125-1136. doi: 10.1016/j.jacc.2012.08.1039.
21. Jerez-Valero M, Urena M, Webb JG, Tamburino C, Munoz-Garcia AJ, Cheema A, Dager AE, Serra V, Amat-Santos IJ, Barbanti M, Immè S, Alonso Briales JH, Al Lawati H, Benitez LM, Cucalon AM, Garcia del Blanco B, Revilla A, Dumont E, Barbosa Ribeiro H, Nombela-Franco L, Bergeron S, Pibarot P, Rodés-Cabau J. Clinical impact of aortic regurgitation after transcatheter aortic valve replacement: insights into the degree and acuteness of presentation. JACC Cardiovasc Interv. 2014;7:1022-1032. doi: 10.1016/j.jcin.2014.04.012.
22. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686-1695. doi: 10.1056/NEJMoa1200384.
23. Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrié D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012;366:1705-1715. doi: 10.1056/NEJMoa1114705.
24. Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA, Wendler O, Hildick-Smith D, Davies SW, Trivedi U, Blackman DJ, Levy RD, Brecker SJ, Baumbach A, Daniel T, Gray H, Mullen MJ. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011;58:2130-2138. doi: 10.1016/j.jacc.2011.08.050.
25. Freeman M, Barbanti M, Wood DA, Ye J, Webb JG. Cerebral events and protection during transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2014;84:885-896. doi: 10.1002/ccd.25457.
26. Praz F, Nietlispach F. Cerebral protection devices for transcatheter aortic valve implantation: is better the enemy of good? EuroIntervention. 2013;9(suppl):S124-S128. doi: 10.4244/EIJV9SSA26.
27. Généreux P, Webb JG, Svensson LG, Kodali SK, Satler LF, Fearon WF, Davidson CJ, Eisenhauer AC, Makkar RR, Bergman GW, Babaliaros V, Bavaria JE, Velazquez OC, Williams MR, Hueter I, Xu K, Leon MB; PARTNER Trial Investigators. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial. J Am Coll Cardiol. 2012;60:1043-1052. doi: 10.1016/j.jacc.2012.07.003.
28. Toggweiler S, Gurvitch R, Leipsic J, Wood DA, Willson AB, Binder RK, Cheung A, Ye J, Webb JG. Percutaneous aortic valve replacement: vascular outcomes with a fully percutaneous procedure. J Am Coll Cardiol. 2012;59:113-118. doi: 10.1016/j.jacc.2011.08.069.
29. Binder RK, Barbanti M, Ye J, Toggweiler S, Tan J, Freeman M, Cheung A, Wood DA, Webb JG. Blood loss and transfusion rates associated with transcatheter aortic valve replacement: recommendations for patients who refuse blood transfusion. Catheter Cardiovasc Interv. 2014;83:E221-E226. doi: 10.1002/ccd.25389.
30. Pilgrim T, Stortecky S, Luterbacher F, Windecker S, Wenaweser P. Transcatheter aortic valve implantation and bleeding: incidence, predictors and prognosis. J Thromb Thrombolysis. 2013;35:456-462. doi: 10.1007/s11239-012-0842-3.
31. Mouillet G, Lellouche N, Yamamoto M, Oguri A, Dubois-Rande JL, Van Belle E, Gilard M, Laskar M, Teiger E. Outcomes following pacemaker implantation after transcatheter aortic valve implantation with CoreValve(® ) devices: Results from the FRANCE 2 Registry. Catheter Cardiovasc Interv. 2015;86:E158-E166. doi: 10.1002/ccd.25818.
32. Meredith IT, Worthley SG, Whitbourn RJ, Antonis P, Montarello JK, Newcomb AE, Lockwood S, Haratani N, Allocco DJ, Dawkins KD. Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study. EuroIntervention. 2014;9:1264-1270. doi: 10.4244/EIJV9I11A216.
33. Abdel-Wahab M, Mehilli J, Frerker C, Neumann FJ, Kurz T, Tölg R, Zachow D, Guerra E, Massberg S, Schäfer U, El-Mawardy M, Richardt G; CHOICE investigators. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA. 2014;311:1503-1514. doi: 10.1001/jama.2014.3316.
34. Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, El-Chami MF, Herrmann HC, Mack M, Makkar RR, Miller DC, Pichard A, Tuzcu EM, Szeto WY, Webb JG, Moses JW, Smith CR, Williams MR, Leon MB, Kodali SK; PARTNER Publications Office. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc Interv. 2015;8(1 pt A):60-69. doi: 10.1016/j.jcin.2014.07.022.
35. Binder RK, Webb JG, Toggweiler S, Freeman M, Barbanti M, Willson AB, Alhassan D, Hague CJ, Wood DA, Leipsic J. Impact of post-implant SAPIEN XT geometry and position on conduction disturbances, hemodynamic performance, and paravalvular regurgitation. JACC Cardiovasc Interv. 2013;6:462-468. doi: 10.1016/j.jcin.2012.12.128.
36. Tarantini G, Mojoli M, Purita P, Napodano M, D'Onofrio A, Frigo A, Covolo E, Facchin M, Isabella G, Gerosa G, Iliceto S. Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve. EuroIntervention. 2015;11:343-350. doi: 10.4244/EIJY14M11-06.
37. Urena M, Webb JG, Tamburino C, Munõz-Garciá AJ, Cheema A, Dager AE, Serra V, Amat-Santos IJ, Barbanti M, Immè S, Briales JH, Benitez LM, Al Lawati H, Cucalon AM, Garciá Del Blanco B, López J, Dumont E, Delarochellière R, Ribeiro HB, Nombela-Franco L, Philippon F, Rodés-Cabau J. Permanent pacemaker implantation after transcatheter aortic valve implantation: impact on late clinical outcomes and left ventricular function. Circulation. 2014;129:1233-1243. doi: 10.1161/CIRCULATIONAHA.113.005479.