Comparison of a novel self-expanding transcatheter heart valve with two established devices for treatment of degenerated surgical aortic bioprostheses.
Aortic valve disease
Bioprosthetic valves
TAVI
Valve-in-valve
Journal
Clinical research in cardiology : official journal of the German Cardiac Society
ISSN: 1861-0692
Titre abrégé: Clin Res Cardiol
Pays: Germany
ID NLM: 101264123
Informations de publication
Date de publication:
05 Apr 2023
05 Apr 2023
Historique:
received:
25
10
2022
accepted:
03
03
2023
pubmed:
6
4
2023
medline:
6
4
2023
entrez:
5
4
2023
Statut:
aheadofprint
Résumé
This study was performed to compare haemodynamic properties of a novel transcatheter heart valve (THV) with two established valve technologies for treatment of failing surgical aortic bioprosthetic valves (SAV). The ALLEGRA THV has been recently described with a proven safety and performance profile. The study was designed as a retrospective, single-centre study investigating 112 patients (77.7 ± 7.1 years, 53.8% female, STS score 6.8 ± 5.8% and logEuroSCORE I 27.4 ± 16.1%) with failing SAV. Patients were treated with the ALLEGRA THV (NVT, n = 24), the CoreValve/EvolutR (MTD, n = 64) or the Edwards Sapien/Sapien XT/Sapien 3 (EDW, n = 24). Adverse events, haemodynamic outcomes and patient safety were analysed according to VARC-3 definitions. Overall procedural success was high (94.6%), even though 58.9% of the treated SAV were classified as small (true inner diameter < 21 mm). After treatment, the mean pressure gradient was significantly reduced (baseline: 33.7 ± 16.5 mmHg, discharge: 18.0 ± 7.1 mmHg), with a corresponding increase in effective orifice area (EOA). The complication rates did not differ in between groups. There was a trend to lower mean transvalvular gradients after implantation of self-expanding THV with supra-annular valve function, despite a higher frequency of smaller SAVs in the NVT and MTD group. Additionally, comparison between NVT and MTD revealed statistically lower transvalvular gradients (NVT 14.9 ± 5.0 mmHg, MTD 18.7 ± 7.5 mmHg, p = 0.0295) in a subgroup analysis. Valve-in-valve (ViV) treatment of failing SAV with supra-annular design like the ALLEGRA THV resulted in favourable haemodynamic outcomes with similar low clinical event rates and may therefore be an interesting alternative for VIV TAVI.
Identifiants
pubmed: 37017780
doi: 10.1007/s00392-023-02181-9
pii: 10.1007/s00392-023-02181-9
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023. The Author(s).
Références
Thourani VH, Suri RM, Gunter RL, Sheng S, O’Brien SM, Ailawadi G, Szeto WY, Dewey TM, Guyton RA, Bavaria JE, Babaliaros V, Gammie JS, Svensson L, Williams M, Badhwar V, Mack MJ (2015) Contemporary real-world outcomes of surgical aortic valve replacement in 141,905 low-risk, intermediate-risk, and high-risk patients. Ann Thorac Surg 99(1):55–61. https://doi.org/10.1016/j.athoracsur.2014.06.050
doi: 10.1016/j.athoracsur.2014.06.050
pubmed: 25442986
Beckmann A, Funkat AK, Lewandowski J, Frie M, Ernst M, Hekmat K, Schiller W, Gummert JF, Cremer JT (2015) Cardiac surgery in Germany during 2014: a report on Behalf of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg 63(4):258–269. https://doi.org/10.1055/s-0035-1551676
doi: 10.1055/s-0035-1551676
pubmed: 26011675
Jones JM, O’Kane H, Gladstone DJ, Sarsam MA, Campalani G, MacGowan SW, Cleland J, Cran GW (2001) Repeat heart valve surgery: risk factors for operative mortality. J Thorac Cardiovasc Surg 122(5):913–918. https://doi.org/10.1067/mtc.2001.116470
doi: 10.1067/mtc.2001.116470
pubmed: 11689796
David TE, Ivanov J, Armstrong S, Feindel CM, Cohen G (2001) Late results of heart valve replacement with the Hancock II bioprosthesis. J Thorac Cardiovasc Surg 121(2):268–277. https://doi.org/10.1067/mtc.2001.112208
doi: 10.1067/mtc.2001.112208
pubmed: 11174732
Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL, E. S. C. S. D. Group (2017) 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 38(36):2739–2791. https://doi.org/10.1093/eurheartj/ehx391
doi: 10.1093/eurheartj/ehx391
pubmed: 28886619
Ferrari E, Stortecky S, Heg D, Muller O, Nietlispach F, Tueller D, Toggweiler S, Noble S, Maisano F, Roffi M, Jeger R, Grünenfelder J, Huber C, Windecker S, Wenaweser P (2019) The hospital results and 1-year outcomes of transcatheter aortic valve-in-valve procedures and transcatheter aortic valve implantations in the native valves: the results from the Swiss-TAVI Registry. Eur J Cardiothorac Surg 56(1):55–63. https://doi.org/10.1093/ejcts/ezy471
doi: 10.1093/ejcts/ezy471
pubmed: 30689870
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, Investigators PT (2010) Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363(17):1597–1607. https://doi.org/10.1056/NEJMoa1008232
doi: 10.1056/NEJMoa1008232
pubmed: 20961243
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, Investigators PT (2011) Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 364(23):2187–2198. https://doi.org/10.1056/NEJMoa1103510
doi: 10.1056/NEJMoa1103510
pubmed: 21639811
Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK, I. CoreValve United States Clinical (2014) Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol 63(19):1972–1981. https://doi.org/10.1016/j.jacc.2014.02.556
doi: 10.1016/j.jacc.2014.02.556
pubmed: 24657695
Adams DH, Popma JJ, Reardon MJ (2014) Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 371(10):967–968. https://doi.org/10.1056/NEJMc1408396
doi: 10.1056/NEJMc1408396
pubmed: 25184874
Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG, Investigators P (2016) Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 374(17):1609–1620. https://doi.org/10.1056/NEJMoa1514616
doi: 10.1056/NEJMoa1514616
pubmed: 27040324
Webb JG, Mack MJ, White JM, Dvir D, Blanke P, Herrmann HC, Leipsic J, Kodali SK, Makkar R, Miller DC, Pibarot P, Pichard A, Satler LF, Svensson L, Alu MC, Suri RM, Leon MB (2017) transcatheter aortic valve implantation within degenerated aortic surgical bioprostheses: PARTNER 2 valve-in-valve registry. J Am Coll Cardiol 69(18):2253–2262. https://doi.org/10.1016/j.jacc.2017.02.057
doi: 10.1016/j.jacc.2017.02.057
pubmed: 28473128
Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP (2017) Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med 376(14):1321–1331. https://doi.org/10.1056/NEJMoa1700456
doi: 10.1056/NEJMoa1700456
pubmed: 28304219
Tchetche D, Chevalier B, Holzhey D, Harnath A, Schafer U, Teiger E, Manigold T, Modine T, Souteyrand G, Champagnac D, Oh JK, Li S, Verhoye JP, Kornowski R, Investigators V (2019) TAVR for failed surgical aortic bioprostheses using a self-expanding device: 1-year results from the prospective VIVA postmarket study. JACC Cardiovasc Interv 12(10):923–932. https://doi.org/10.1016/j.jcin.2019.02.029
doi: 10.1016/j.jcin.2019.02.029
pubmed: 31122349
Dvir D, Webb JG, Bleiziffer S, Pasic M, Waksman R, Kodali S, Barbanti M, Latib A, Schaefer U, Rodes-Cabau J, Treede H, Piazza N, Hildick-Smith D, Himbert D, Walther T, Hengstenberg C, Nissen H, Bekeredjian R, Presbitero P, Ferrari E, Segev A, de Weger A, Windecker S, Moat NE, Napodano M, Wilbring M, Cerillo AG, Brecker S, Tchetche D, Lefevre T, De Marco F, Fiorina C, Petronio AS, Teles RC, Testa L, Laborde JC, Leon MB, Kornowski R, I. Valve-in-Valve International Data Registry (2014) Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA 312(2):162–170. https://doi.org/10.1001/jama.2014.7246
doi: 10.1001/jama.2014.7246
pubmed: 25005653
Simonato M, Webb J, Kornowski R, Vahanian A, Frerker C, Nissen H, Bleiziffer S, Duncan A, Rodes-Cabau J, Attizzani GF, Horlick E, Latib A, Bekeredjian R, Barbanti M, Lefevre T, Cerillo A, Hernandez JM, Bruschi G, Spargias K, Iadanza A, Brecker S, Palma JH, Finkelstein A, Abdel-Wahab M, Lemos P, Petronio AS, Champagnac D, Sinning JM, Salizzoni S, Napodano M, Fiorina C, Marzocchi A, Leon M, Dvir D (2016) Transcatheter replacement of failed bioprosthetic valves: large multicenter assessment of the effect of implantation depth on hemodynamics after aortic valve-in-valve. Circ Cardiovasc Interv 9(6):eee03651. https://doi.org/10.1161/CIRCINTERVENTIONS.115.003651
doi: 10.1161/CIRCINTERVENTIONS.115.003651
Deeb GM, Chetcuti SJ, Reardon MJ, Patel HJ, Grossman PM, Schreiber T, Forrest JK, Bajwa TK, O’Hair DP, Petrossian G, Robinson N, Katz S, Hartman A, Dauerman HL, Schmoker J, Khabbaz K, Watson DR, Yakubov SJ, Oh JK, Li S, Kleiman NS, Adams DH, Popma JJ (2017) 1-Year results in patients undergoing transcatheter aortic valve replacement with failed surgical bioprostheses. JACC Cardiovasc Interv 10(10):1034–1044. https://doi.org/10.1016/j.jcin.2017.03.018
doi: 10.1016/j.jcin.2017.03.018
pubmed: 28521921
Pibarot P, Simonato M, Barbanti M, Linke A, Kornowski R, Rudolph T, Spence M, Moat N, Aldea G, Mennuni M, Iadanza A, Amrane H, Gaia D, Kim WK, Napodano M, Baumbach H, Finkelstein A, Kobayashi J, Brecker S, Don C, Cerillo A, Unbehaun A, Attias D, Nejjari M, Jones N, Fiorina C, Tchetche D, Philippart R, Spargias K, Hernandez JM, Latib A, Dvir D (2018) Impact of pre-existing prosthesis-patient mismatch on survival following aortic valve-in-valve procedures. JACC Cardiovasc Interv 11(2):133–141. https://doi.org/10.1016/j.jcin.2017.08.039
doi: 10.1016/j.jcin.2017.08.039
pubmed: 29348008
Wenaweser P, Stortecky S, Schutz T, Praz F, Gloekler S, Windecker S, Elsasser A (2016) Transcatheter aortic valve implantation with the NVT Allegra transcatheter heart valve system: first-in-human experience with a novel self-expanding transcatheter heart valve. EuroIntervention 12(1):71–77. https://doi.org/10.4244/EIJV12I1A13
doi: 10.4244/EIJV12I1A13
pubmed: 27173865
Schafer U, Kalbacher D, Voigtlander L, Conradi L (2018) First-in-human implantation of a novel self-expanding supra-annular transcatheter heart valve for transcatheter aortic valve implantation inside a small degenerated aortic surgical bioprosthesis. Catheter Cardiovasc Interv 92(7):1453–1457. https://doi.org/10.1002/ccd.27466
doi: 10.1002/ccd.27466
pubmed: 29359506
Jagielak D, Stanska A, Klapkowski A, Brzezinski M, Kowalik M, Ciecwierz D, Jaguszewski M, Fijalkowski M (2019) Transfermoral aortic valve implantation using self-expanding New Valve Technology (NVT) Allegra bioprosthesis: a pilot prospective study. Cardiol J 28(3):384–390. https://doi.org/10.5603/CJ.a2019.0019
doi: 10.5603/CJ.a2019.0019
pubmed: 30761515
Sedaghat A, Sinning JM, Werner N, Nickenig G, Conradi L, Toggweiler S, Schäfer U (2018) In vitro hydrodynamic and acute clinical performance of a novel self-expanding transcatheter heart valve in various surgical bioprostheses. EuroIntervention 13(17):2014–2017. https://doi.org/10.4244/EIJ-D-17-00844 . (PMID: 29260712)
doi: 10.4244/EIJ-D-17-00844
pubmed: 29260712
Sathananthan J, Fraser R, Kütting M, Hensey M, Landes U, Alkhodair A, Sedaghat A, Blanke P, Toggweiler S, Leipsic J, Søndergaard L, Wood D, Webb JG (2020) Impact of implant depth on hydrodynamic function of the ALLEGRA bioprosthesis in valve-in-valve interventions. EuroIntervention 15(15):e1335–e1342. https://doi.org/10.4244/EIJ-D-19-00782
doi: 10.4244/EIJ-D-19-00782
pubmed: 31607682
Schafer U, Butter C, Landt M, Frerker C, Treede H, Schirmer J, Koban C, Allali A, Schmidt T, Charitos E, Conradi L (2019) Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study. EuroIntervention 15(9):e757–e763. https://doi.org/10.4244/EIJ-D-19-00331
doi: 10.4244/EIJ-D-19-00331
pubmed: 31355750
Schäfer U, Butter C, Landt M, Frerker C, Treede H, Schirmer J, Koban C, Allali A, Schmidt T, Charitos E, Nikolayevska O, Conradi L (2021) One-year clinical outcomes of a novel transcatheter heart valve to treat degenerated surgical valves—the “VIVALL” study. EuroIntervention 17(13):1077–1080. https://doi.org/10.4244/EIJ-D-20-01241
doi: 10.4244/EIJ-D-20-01241
Lancellotti P, Tribouilloy C, Hagendorff A, Moura L, Popescu BA, Agricola E, Monin JL, Pierard LA, Badano L, Zamorano JL (2010) European Association of Echocardiography. European Association of Echocardiography recommendations for the assessment of valvular regurgitation. Part 1: aortic and pulmonary regurgitation (native valve disease). Eur J Echocardiogr 3:223–244. https://doi.org/10.1093/ejechocard/jeq030 . (PMID: 20375260)
doi: 10.1093/ejechocard/jeq030
Dvir D, Webb J, Brecker S, Bleiziffer S, Hildick-Smith D, Colombo A, Descoutures F, Hengstenberg C, Moat NE, Bekeredjian R, Napodano M, Testa L, Lefevre T, Guetta V, Nissen H, Hernández JM, Roy D, Teles RC, Segev A, Dumonteil N, Fiorina C, Gotzmann M, Tchetche D, Abdel-Wahab M, De Marco F, Baumbach A, Laborde JC, Kornowski R (2012) Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: results from the global valve-in-valve registry. Circulation 126(19):2335–2344. https://doi.org/10.1161/CIRCULATIONAHA.112.104505
doi: 10.1161/CIRCULATIONAHA.112.104505
pubmed: 23052028
Ribeiro HB, Rodés-Cabau J, Blanke P, Leipsic J, Kwan Park J, Bapat V, Makkar R, Simonato M, Barbanti M, Schofer J, Bleiziffer S, Latib A, Hildick-Smith D, Presbitero P, Windecker S, Napodano M, Cerillo AG, Abdel-Wahab M, Tchetche D, Fiorina C, Sinning JM, Cohen MG, Guerrero ME, Whisenant B, Nietlispach F, Palma JH, Nombela-Franco L, de Weger A, Kass M, Sandoli de Brito Jr. F, Lemos PA, Kornowski R, Webb J, Dvir D (2018) Incidence, predictors, and clinical outcomes of coronary obstruction following transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: insights from the VIVID registry. Eur Heart J 39(8):687–695. https://doi.org/10.1093/eurheartj/ehx455
doi: 10.1093/eurheartj/ehx455
pubmed: 29020413
Tarantini G, Dvir D, Tang GHL (2021) Transcatheter aortic valve implantation in degenerated surgical aortic valves. EuroIntervention 17(9):709–719. https://doi.org/10.4244/EIJ-D-21-00157 . (PMID: 34665140)
doi: 10.4244/EIJ-D-21-00157
pubmed: 34665140
pmcid: 9725043
Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB, VARC-3 WRITING COMMITTEE (2021) Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J 42(19):1825–1857. https://doi.org/10.1093/eurheartj/ehaa799 . (PMID: 33871579)
doi: 10.1093/eurheartj/ehaa799
pubmed: 33871579
Moreno R, Baz JA, Moreu J, Berenguer A, Gonzálvez-García A, Galeote G, Hernández U, Cantón T, Jiménez-Valero S, Jurado-Román A, Moya H, Lázaro E (2021) Transcatheter aortic valve implantation for degenerated aortic valves: experience with a new supra-annular device. The Spanish Allegra valve-in-valve (SAVIV) registry. Catheter Cardiovasc Interv 98(2):365–370. https://doi.org/10.1002/ccd.29742 . (Epub 2021 Apr 23. PMID: 33890713)
doi: 10.1002/ccd.29742
pubmed: 33890713
Neuser J, Kempf T, Bauersachs J, Widder JD (2022) Novel self-expanding ALLEGRA transcatheter aortic valve for native aortic stenosis and degenerated bioprosthesis. Catheter Cardiovasc Interv 99(4):1234–1242. https://doi.org/10.1002/ccd.30003
doi: 10.1002/ccd.30003
pubmed: 34787372
Christie GW, Barratt-Boyes BG (1991) On stress reduction in bioprosthetic heart valve leaflets by the use of a flexible stent. J Card Surg 1(4):476–481. https://doi.org/10.1111/j.1540-8191.1991.tb00348.x . (PMID: 1815772)
doi: 10.1111/j.1540-8191.1991.tb00348.x
Hatoum H, Gooden SCM, Sathananthan J, Sellers S, Kutting M, Marx P, Lilly SM, Ihdayhid AR, Thourani VH, Dasi LP (2021) Neosinus and sinus flow after self-expanding and balloon-expandable transcatheter aortic valve replacement. JACC Cardiovasc Interv 14(24):2657–2666. https://doi.org/10.1016/j.jcin.2021.09.013 . (Epub 2021 Nov 24 PMID: 34838462)
doi: 10.1016/j.jcin.2021.09.013
pubmed: 34838462
Hatoum H, Samaee M, Sathananthan J, Sellers S, Kuetting M, Lilly SM, Ihdayhid AR, Blanke P, Leipsic J, Thourani VH, Dasi LP (2022) Comparison of performance of self-expanding and balloon-expandable transcatheter aortic valves. JTCVS Open 10:128–139. https://doi.org/10.1016/j.xjon.2022.04.015 . (PMID: 36004225; PMCID: PMC9390782)
doi: 10.1016/j.xjon.2022.04.015
pubmed: 36004225
pmcid: 9390782
Cuevas O, Moreno R, Pascual-Tejerina V, Toggweiler S, Brinkert M, Baz J, Jimenez V, Molina E, Sánchez-Gila J, Taramasso M, Nietlispach F (2019) The Allegra transcatheter heart valve: European multicentre experience with a novel self-expanding transcatheter aortic valve. EuroIntervention 15(1):71–73. https://doi.org/10.4244/EIJ-D-18-00861 . (PMID: 30777839)
doi: 10.4244/EIJ-D-18-00861
pubmed: 30777839