Advertisement

Transfemoral Aortic Valve Implantation in Patients With an Annulus Dimension Suitable for Either the Edwards Valve or the CoreValve

      The aim of this study was to compare the outcomes of transcatheter aortic valve implantation using the Edwards SAPIEN valve and the Medtronic CoreValve in patients with annulus of intermediate size (20 to 25 mm). From October 2008 to April 2012, 662 consecutive patients who underwent transcatheter aortic valve implantation were studied at 2 French centers. After propensity score matching, a total of 192 patients with intermediate-sized aortic annulus who had received either Edwards (n = 96, mean age 82.4 ± 7.9 years, 48% men, 61.9% receiving the 26-mm valve) or CoreValve (n = 96, mean age 82.5 ± 7.7 years, 50% men, 64.6% receiving the 29-mm valve) prostheses through the transfemoral approach were studied. Adequate reduction in postprocedural mean pressure gradients was achieved with the Edwards valve and the CoreValve (10.9 ± 4.7 vs 9.1 ± 4.4 mm Hg, respectively, p <0.01). Major vascular complications (5.2% vs 3.1%, p = 0.36), device success (95.8% vs 93.8%, p = 0.52), and 30-day survival (90.6% vs 89.6%, p = 0.81) were similar. The incidence of postprocedural aortic regurgitation grade ≥2/4 and new pacemaker implantation was more frequent in the CoreValve group (14.3% vs 35.5%, p <0.01, and 4.2% vs 18.8%, p <0.01, respectively). There was no significant difference in 1-year cumulative survival rates in the Edwards valve group compared with the CoreValve group (80.1 ± 4.2% vs 75.6 ± 4.9%, log-rank p = 0.31). In conclusion, in patients with annulus of intermediate size, similar device success and short-term and midterm outcomes were achieved with either of the valves, irrespective of the specific complications related to each valve.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to American Journal of Cardiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Webb J.
        • Cribier A.
        Percutaneous transarterial aortic valve implantation: what do we know?.
        Eur Heart J. 2011; 32: 140-147
        • 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.
        • Carrie 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 J.P.
        • Bourlon F.
        • Bertrand B.
        • Van Belle E.
        • Laskar M.
        Registry of transcatheter aortic-valve implantation in high-risk patients.
        N Engl J Med. 2012; 366: 1705-1715
        • Moat N.E.
        • Ludman P.
        • de Belder M.A.
        • Bridgewater B.
        • Cunningham A.D.
        • Young C.P.
        • Thomas M.
        • Kovac J.
        • Spyt T.
        • MacCarthy P.A.
        • Wendler O.
        • Hildick-Smith D.
        • Davies S.W.
        • Trivedi U.
        • Blackman D.J.
        • Levy R.D.
        • Brecker S.J.
        • Baumbach A.
        • Daniel T.
        • Gray H.
        • Mullen M.J.
        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
        • Zahn R.
        • Gerckens U.
        • Grube E.
        • Linke A.
        • Sievert H.
        • Eggebrecht H.
        • Hambrecht R.
        • Sack S.
        • Hauptmann K.E.
        • Richardt G.
        • Figulla H.R.
        • Senges J.
        Transcatheter aortic valve implantation: first results from a multi-centre real-world registry.
        Eur Heart J. 2011; 32: 198-204
        • Hayashida K.
        • Bouvier E.
        • Lefevre T.
        • Hovasse T.
        • Morice M.C.
        • Chevalier B.
        • Romano M.
        • Garot P.
        • Mylotte D.
        • Farge A.
        • Donzeau-Gouge P.
        • Cormier B.
        Impact of CT-guided valve sizing on post-procedural aortic regurgitation in transcatheter aortic valve implantation.
        EuroIntervention. 2012; 8: 546-555
        • Kappetein A.P.
        • Head S.J.
        • Genereux P.
        • Piazza N.
        • van Mieghem N.M.
        • Blackstone E.H.
        • Brott T.G.
        • Cohen D.J.
        • Cutlip D.E.
        • van Es G.A.
        • Hahn R.T.
        • Kirtane A.J.
        • Krucoff M.W.
        • Kodali S.
        • Mack M.J.
        • Mehran R.
        • Rodes-Cabau J.
        • Vranckx P.
        • Webb J.G.
        • Windecker S.
        • Serruys P.W.
        • Leon M.B.
        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
        • Eltchaninoff H.
        • Prat A.
        • Gilard M.
        • Leguerrier A.
        • Blanchard D.
        • Fournial G.
        • Iung B.
        • Donzeau-Gouge P.
        • Tribouilloy C.
        • Debrux J.L.
        • Pavie A.
        • Gueret P.
        Transcatheter aortic valve implantation: early results of the FRANCE (French Aortic National CoreValve and Edwards) registry.
        Eur Heart J. 2011; 32: 191-197
        • Kodali S.K.
        • Williams M.R.
        • Smith C.R.
        • Svensson L.G.
        • Webb J.G.
        • Makkar R.R.
        • Fontana G.P.
        • Dewey T.M.
        • Thourani V.H.
        • Pichard A.D.
        • Fischbein M.
        • Szeto W.Y.
        • Lim S.
        • Greason K.L.
        • Teirstein P.S.
        • Malaisrie S.C.
        • Douglas P.S.
        • Hahn R.T.
        • Whisenant B.
        • Zajarias A.
        • Wang D.
        • Akin J.J.
        • Anderson W.N.
        • Leon M.B.
        Two-year outcomes after transcatheter or surgical aortic-valve replacement.
        N Engl J Med. 2012; 366: 1686-1695
        • Chieffo A.
        • Buchanan G.L.
        • Van Mieghem N.M.
        • Tchetche D.
        • Dumonteil N.
        • Latib A.
        • van der Boon R.M.
        • Vahdat O.
        • Marcheix B.
        • Farah B.
        • Serruys P.W.
        • Fajadet J.
        • Carrie D.
        • de Jaegere P.P.
        • Colombo A.
        Transcatheter aortic valve implantation with the Edwards SAPIEN versus the Medtronic CoreValve ReValving System devices: a multicenter collaborative study: the PRAGMATIC Plus Initiative (Pooled-Rotterdam-Milano-Toulouse in Collaboration).
        J Am Coll Cardiol. 2013; 61: 830-836
        • Pasic M.
        • Unbehaun A.
        • Dreysse S.
        • Buz S.
        • Drews T.
        • Kukucka M.
        • D'Ancona G.
        • Seifert B.
        • Hetzer R.
        Rupture of the device landing zone during transcatheter aortic valve implantation: a life-threatening but treatable complication.
        Circ Cardiovasc Interv. 2012; 5: 424-432
        • Hayashida K.
        • Bouvier E.
        • Lefevre T.
        • Hovasse T.
        • Morice M.C.
        • Chevalier B.
        • Romano M.
        • Garot P.
        • Farge A.
        • Donzeau-Gouge P.
        • Cormier B.
        Potential mechanism of annulus rupture during transcatheter aortic valve implantation.
        Catheter Cardiovasc Interv. 2012; ([Epub ahead of print: June 21])
        • Blanke P.
        • Reinohl J.
        • Schlensak C.
        • Siepe M.
        • Pache G.
        • Euringer W.
        • Geibel-Zehender A.
        • Bode C.
        • Langer M.
        • Beyersdorf F.
        • Zehender M.
        Prosthesis oversizing in balloon-expandable transcatheter aortic valve implantation is associated with contained rupture of the aortic root.
        Circ Cardiovasc Interv. 2012; 5: 540-548
        • Jilaihawi H.
        • Kashif M.
        • Fontana G.
        • Furugen A.
        • Shiota T.
        • Friede G.
        • Makhija R.
        • Doctor N.
        • Leon M.B.
        • Makkar R.R.
        Cross-sectional computed tomographic assessment improves accuracy of aortic annular sizing for transcatheter aortic valve replacement and reduces the incidence of paravalvular aortic regurgitation.
        J Am Coll Cardiol. 2012; 59: 1275-1286
        • Schultz C.J.
        • Moelker A.D.
        • Tzikas A.
        • Rossi A.
        • van Geuns R.J.
        • de Feyter P.J.
        • Serruys P.W.
        Cardiac CT: necessary for precise sizing for transcatheter aortic implantation.
        EuroIntervention. 2010; 6: G6-G13
        • Lefevre T.
        • Kappetein A.P.
        • Wolner E.
        • Nataf P.
        • Thomas M.
        • Schachinger V.
        • De Bruyne B.
        • Eltchaninoff H.
        • Thielmann M.
        • Himbert D.
        • Romano M.
        • Serruys P.
        • Wimmer-Greinecker G.
        One year follow-up of the multi-centre European PARTNER transcatheter heart valve study.
        Eur Heart J. 2011; 32: 148-157
        • Stabile E.
        • Sorropago G.
        • Cioppa A.
        • Cota L.
        • Agrusta M.
        • Lucchetti V.
        • Rubino P.
        Acute left main obstructions following TAVI.
        EuroIntervention. 2010; 6: 100-105
        • Webb J.G.
        Coronary obstruction due to transcatheter valve implantation.
        Catheter Cardiovasc Interv. 2009; 73: 973
        • Khawaja M.Z.
        • Rajani R.
        • Cook A.
        • Khavandi A.
        • Moynagh A.
        • Chowdhary S.
        • Spence M.S.
        • Brown S.
        • Khan S.Q.
        • Walker N.
        • Trivedi U.
        • Hutchinson N.
        • De Belder A.J.
        • Moat N.
        • Blackman D.J.
        • Levy R.D.
        • Manoharan G.
        • Roberts D.
        • Khogali S.S.
        • Crean P.
        • Brecker S.J.
        • Baumbach A.
        • Mullen M.
        • Laborde J.C.
        • Hildick-Smith D.
        Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing factors (the UK CoreValve Collaborative).
        Circulation. 2011; 123: 951-960
        • Munoz-Garcia A.J.
        • Hernandez-Garcia J.M.
        • Jimenez-Navarro M.F.
        • Alonso-Briales J.H.
        • Dominguez-Franco A.J.
        • Fernandez-Pastor J.
        • Pena Hernandez J.
        • Barrera Cordero A.
        • Alzueta Rodriguez J.
        • de Teresa-Galvan E.
        Factors predicting and having an impact on the need for a permanent pacemaker after CoreValve prosthesis implantation using the new Accutrak delivery catheter system.
        JACC Cardiovasc Interv. 2012; 5: 533-539
        • Tchetche D.
        • Modine T.
        • Farah B.
        • Vahdat O.
        • Sudre A.
        • Koussa M.
        • Lereun C.
        • Nejjari M.
        • Choby M.
        • Rosencher J.
        • Sorbets E.
        • Fajadet J.
        Update on the need for a permanent pacemaker after transcatheter aortic valve implantation using the CoreValve® Accutrak system.
        EuroIntervention. 2012; 8: 556-562
        • Thomas M.
        • Schymik G.
        • Walther T.
        • Himbert D.
        • Lefevre T.
        • Treede H.
        • Eggebrecht H.
        • Rubino P.
        • Michev I.
        • Lange R.
        • Anderson W.N.
        • Wendler O.
        Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.
        Circulation. 2010; 122: 62-69
        • Sinning J.M.
        • Hammerstingl C.
        • Vasa-Nicotera M.
        • Adenauer V.
        • Lema Cachiguango S.J.
        • Scheer A.C.
        • Hausen S.
        • Sedaghat A.
        • Ghanem A.
        • Muller C.
        • Grube E.
        • Nickenig G.
        • Werner N.
        Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation.
        J Am Coll Cardiol. 2012; 59: 1134-1141
        • Tamburino C.
        • Capodanno D.
        • Ramondo A.
        • Petronio A.S.
        • Ettori F.
        • Santoro G.
        • Klugmann S.
        • Bedogni F.
        • Maisano F.
        • Marzocchi A.
        • Poli A.
        • Antoniucci D.
        • Napodano M.
        • De Carlo M.
        • Fiorina C.
        • Ussia G.P.
        Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis.
        Circulation. 2011; 123: 299-308
        • Hayashida K.
        • Lefevre T.
        • Chevalier B.
        • Hovasse T.
        • Romano M.
        • Garot P.
        • Bouvier E.
        • Farge A.
        • Donzeau-Gouge P.
        • Cormier B.
        • Morice M.C.
        Impact of post-procedural aortic regurgitation on mortality after transcatheter aortic valve implantation.
        JACC Cardiovasc Interv. 2012; 5: 1247-1256
        • Rodes-Cabau J.
        • Webb J.G.
        • Cheung A.
        • Ye J.
        • Dumont E.
        • Osten M.
        • Feindel C.M.
        • Natarajan M.K.
        • Velianou J.L.
        • Martucci G.
        • DeVarennes B.
        • Chisholm R.
        • Peterson M.
        • Thompson C.R.
        • Wood D.
        • Toggweiler S.
        • Gurvitch R.
        • Lichtenstein S.V.
        • Doyle D.
        • DeLarochelliere R.
        • Teoh K.
        • Chu V.
        • Bainey K.
        • Lachapelle K.
        • Cheema A.
        • Latter D.
        • Dumesnil J.G.
        • Pibarot P.
        • Horlick E.
        Long-term outcomes after transcatheter aortic valve implantation: insights on prognostic factors and valve durability from the Canadian multicenter experience.
        J Am Coll Cardiol. 2012; 60: 1864-1875
        • Rajani R.
        • Kakad M.
        • Khawaja M.Z.
        • Lee L.
        • James R.
        • Saha M.
        • Hildick-Smith D.
        Paravalvular regurgitation one year after transcatheter aortic valve implantation.
        Catheter Cardiovasc Interv. 2010; 75: 868-872
        • Giordana F.
        • Capriolo M.
        • Frea S.
        • Marra W.G.
        • Giorgi M.
        • Bergamasco L.
        • Omede P.L.
        • Sheiban I.
        • D'Amico M.
        • Bovolo V.
        • Salizzoni S.
        • La Torre M.
        • Rinaldi M.
        • Marra S.
        • Gaita F.
        • Morello M.
        Impact of TAVI on mitral regurgitation: a prospective echocardiographic study.
        Echocardiography. 2013; 30: 250-257
        • De Chiara B.
        • Moreo A.
        • De Marco F.
        • Musca F.
        • Oreglia J.
        • Lobiati E.
        • Bruschi G.
        • Belli O.
        • Mauri F.
        • Klugmann S.
        Influence of CoreValve ReValving System implantation on mitral valve function: an echocardiographic study in selected patients.
        Catheter Cardiovasc Interv. 2011; 78: 638-644