Routine postdilation after 23 mm Sapien 3 Ultra implantation in the aortic position.
TAVR
balloon‐expandable valve
gradients
prosthesis‐patient mismatch
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
06 Jun 2024
06 Jun 2024
Historique:
revised:
14
04
2024
received:
19
02
2024
accepted:
26
05
2024
medline:
6
6
2024
pubmed:
6
6
2024
entrez:
6
6
2024
Statut:
aheadofprint
Résumé
Residual transprosthetic gradient (TG) after transcatheter aortic valve replacement (TAVR) with balloon-expandable valves (BEV) may be due to suboptimal valve expansion. To compare hemodynamics after TAVR with small BEV according to postdilation strategy. This observational, retrospective cohort study included 184 consecutive patients from a single center treated with 23 mm Sapien 3 Ultra (Edwards Lifesciences) BEV implantation in the aortic position and enrolled between January 2020 and April 2023. Patients treated with routine postdilation (RP, n = 73) were compared to patients treated according to local standard practice (SP, n = 111). Primary endpoint was 30-day mean TG. Secondary endpoints were incidence of 30-day prosthesis-patient mismatch (PPM), technical success and device success. Thirty-day mean TG was lower in RP versus SP (12.3 ± 4.6 mmHg vs. 14.1 ± 5.7 mmHg, p = 0.031), and incidence of PPM was less common with RP versus SP (47.3% vs. 71.0%, p = 0.006). Technical success (98.6% vs. 99.1%, p = 0.637) and device success (93.1% vs. 90.1%, p = 0.330) did not differ between groups. Differences in 30-day mean TG were driven by patients at normal flow (12.1 ± 4.0 mmHg vs. 15.0 ± 5.5 mmHg, p = 0.014), while no differences were evident among patients at low flow (12.5 ± 5.5 mmHg vs. 11.7 ± 5.5 mmHg, p = 0.644). RP decreased height and increased width of BEV, and a linear regression established that final BEV width could predict 30-day mean TG (r = -0.6654, p < 0.0001). RP after TAVR with small BEV was associated with more favorable forward-flow hemodynamics than SP.
Sections du résumé
BACKGROUND
BACKGROUND
Residual transprosthetic gradient (TG) after transcatheter aortic valve replacement (TAVR) with balloon-expandable valves (BEV) may be due to suboptimal valve expansion.
AIMS
OBJECTIVE
To compare hemodynamics after TAVR with small BEV according to postdilation strategy.
METHODS
METHODS
This observational, retrospective cohort study included 184 consecutive patients from a single center treated with 23 mm Sapien 3 Ultra (Edwards Lifesciences) BEV implantation in the aortic position and enrolled between January 2020 and April 2023. Patients treated with routine postdilation (RP, n = 73) were compared to patients treated according to local standard practice (SP, n = 111). Primary endpoint was 30-day mean TG. Secondary endpoints were incidence of 30-day prosthesis-patient mismatch (PPM), technical success and device success.
RESULTS
RESULTS
Thirty-day mean TG was lower in RP versus SP (12.3 ± 4.6 mmHg vs. 14.1 ± 5.7 mmHg, p = 0.031), and incidence of PPM was less common with RP versus SP (47.3% vs. 71.0%, p = 0.006). Technical success (98.6% vs. 99.1%, p = 0.637) and device success (93.1% vs. 90.1%, p = 0.330) did not differ between groups. Differences in 30-day mean TG were driven by patients at normal flow (12.1 ± 4.0 mmHg vs. 15.0 ± 5.5 mmHg, p = 0.014), while no differences were evident among patients at low flow (12.5 ± 5.5 mmHg vs. 11.7 ± 5.5 mmHg, p = 0.644). RP decreased height and increased width of BEV, and a linear regression established that final BEV width could predict 30-day mean TG (r = -0.6654, p < 0.0001).
CONCLUSIONS
CONCLUSIONS
RP after TAVR with small BEV was associated with more favorable forward-flow hemodynamics than SP.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 Wiley Periodicals LLC.
Références
Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American college of Cardiology/American heart association joint committee on clinical practice guidelines. J Am Coll Cardiol. 2021;77(4):450‐500. doi:10.1016/j.jacc.2020.11.035
Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic valve replacement with a balloon‐expandable valve in low‐risk patients. N Engl J Med. 2019;380:1695‐1705. doi:10.1056/NEJMoa1814052
Leone PP, Scotti A, Ho EC, et al. Prosthesis tailoring for patients undergoing transcatheter aortic valve implantation. J Clin Med. 2023;12(1):338. doi:10.3390/jcm12010338
Saia F, Gandolfo C, Palmerini T, et al. In‐hospital and thirty‐day outcomes of the SAPIEN 3 ultra balloon‐expandable transcatheter aortic valve: the S3U registry. EuroIntervention. 2020;15(14):1240‐1247. doi:10.4244/EIJ-D-19-00541
Rheude T, Pellegrini C, Lutz J, et al. Transcatheter aortic valve replacement with Balloon‐Expandable valves. JACC Cardiovasc Interv. 2020;13(22):2631‐2638. doi:10.1016/j.jcin.2020.07.013
Leone PP, Regazzoli D, Pagnesi M, et al. Implantation of contemporary transcatheter aortic valves in small aortic annuli: the international multicentre TAVI‐SMALL 2 registry. EuroIntervention. 2023;19:256‐266. doi:10.4244/EIJ-D-22-00843
Abdel‐Wahab M, Landt M, Neumann FJ, et al. 5‐Year outcomes after TAVR with Balloon‐Expandable versus Self‐Expanding valves. JACC Cardiovasc Interv. 2020;13(9):1071‐1082. doi:10.1016/j.jcin.2019.12.026
Makkar RR, Cheng W, Waksman R, et al. Self‐expanding intra‐annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non‐inferiority trial. Lancet. 2020;396(10252):669‐683. doi:10.1016/S0140-6736(20)31358-1
Hahn RT, Pibarot P, Webb J, et al. Outcomes with post‐dilation following transcatheter aortic valve replacement: the PARTNER I trial (placement of aortic transcatheter valve). JACC Cardiovasc Interv. 2014;7(7):781‐789. doi:10.1016/j.jcin.2014.02.013
Leone PP, Regazzoli D, Pagnesi M, et al. Predictors and clinical impact of Prosthesis‐Patient mismatch after Self‐Expandable TAVR in small annuli. JACC: Cardiovasc Interv. 2021;14(11):1218‐1228. doi:10.1016/j.jcin.2021.03.060
Akodad M, Blanke P, Chuang MYA, et al. Late balloon valvuloplasty for transcatheter heart valve dysfunction. J Am Coll Cardiol. 2022;79(14):1340‐1351. doi:10.1016/j.jacc.2022.01.041
Barbanti M, Yang T‐H, Rodès Cabau J, et al. Anatomical and procedural features associated with aortic root rupture during balloon‐ expandable transcatheter aortic valve replacement. Circulation. 2013;128:244‐253.
Hachinohe D, Latib A, Laricchia A, et al. Anatomic and procedural associations of transcatheter heart valve displacement following evolut R implantation. Catheter Cardiovasc Interv. 2019;93(3):522‐529. doi:10.1002/ccd.27827
Herrmann HC, Pibarot P, Wu C, et al. Bioprosthetic aortic valve hemodynamics: definitions, outcomes, and evidence gaps. J Am Coll Cardiol. 2022;80(5):527‐544. doi:10.1016/j.jacc.2022.06.001
Généreux P, Piazza N, Alu MC, et al. Valve academic research consortium 3: updated endpoint definitions for aortic valve clinical research. J Am Coll Cardiol. 2021;77(21):2717‐2746. doi:10.1016/j.jacc.2021.02.038
Hahn RT, Leipsic J, Douglas PS, et al. Comprehensive echocardiographic assessment of normal transcatheter valve function. JACC Cardiovasc Imag. 2019;12(1):25‐34. doi:10.1016/j.jcmg.2018.04.010
Ternacle J, Guimaraes L, Vincent F, et al. Reclassification of prosthesis‐patient mismatch after transcatheter aortic valve replacement using predicted vs. measured indexed effective orifice area. Euro Heart J Cardiovasc Imag. 2021;22(1):11‐20. doi:10.1093/ehjci/jeaa235
Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979;86(2):420‐428. doi:10.1037//0033-2909.86.2.420
Herrmann HC, Abdel‐Wahab M, Attizzani GF, et al. Rationale and design of the SMall annuli randomized to evolut or SAPIEN trial (SMART Trial). Am Heart J. 2022;243(21):92‐102. doi:10.1016/j.ahj.2021.09.011
Sondergaard L, Walton AS, Worthley SG, et al. Thirty‐day and one‐year outcomes of the navitor transcatheter heart valve in patients with aortic stenosis: the prospective, multicentre, global PORTICO NG study. EuroIntervention. 2023;19:248‐255. doi:10.4244/EIJ-D-22-01108
Okuno T, Terauchi K, Kai T, et al. Enhanced hemodynamic performance of a New‐Generation 23‐mm Balloon‐Expandable transcatheter heart valve. JACC Cardiovasc Interv. 2024;17:454‐456. doi:10.1016/j.jcin.2023.10.056
Khalili H, Pibarot P, Hahn RT, et al. Transvalvular pressure gradients and All‐Cause mortality following TAVR. JACC Cardiovasc Interv. 2022;15(18):1837‐1848. doi:10.1016/j.jcin.2022.07.033
Leone PP, Fazzari F, Cannata F, et al. Clinical and technical challenges of prosthesis‐patient mismatch after transcatheter aortic valve implantation. Front Cardiovasc Med. 2021;8:670457. doi:10.3389/fcvm.2021.670457
Leone PP, Gohar A, Pagnesi M, et al. Clinical outcomes in women and men with small aortic annuli undergoing transcatheter aortic valve implantation: a multicenter, retrospective, propensity score‐matched comparison. Int J Cardiol. 2023;379:16‐23. doi:10.1016/j.ijcard.2023.02.044
Sá MP, Jacquemyn X, Van den Eynde J, et al. Impact of Prosthesis‐Patient mismatch after transcatheter aortic valve replacement. JACC Cardiovasc Imag. 2023;16(3):298‐310. doi:10.1016/j.jcmg.2022.07.013
Kalogeras K, Jabbour RJ, Pracon R, et al. Midterm outcomes in patients with aortic stenosis treated with contemporary balloon‐expandable and self‐expanding valves: does valve size have an impact on outcome? J Am Heart Assoc. 2023;12:e028038. doi:10.1161/JAHA.122.028038
Nombela‐Franco L, Webb JG, de Jaegere PP, et al. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation. 2012;126(25):3041‐3053. doi:10.1161/CIRCULATIONAHA.112.110981
Kleiman NS, Maini BJ, Reardon MJ, et al. Neurological events following transcatheter aortic valve replacement and their predictors: a report from the CoreValve trials. Circ Cardiovasc Interv. 2016;9(9):e003551. doi:10.1161/CIRCINTERVENTIONS.115.003551
Nombela‐Franco L, Rodés‐Cabau J, DeLarochellière R, et al. Predictive factors, efficacy, and safety of balloon post‐dilation after transcatheter aortic valve implantation with a balloon‐expandable valve. JACC Cardiovasc Interv. 2012;5(5):499‐512. doi:10.1016/j.jcin.2012.02.010
Gallone G, Islas F, Gorla R, et al. Stroke volume index and transvalvular flow rate trajectories in severe aortic stenosis treated with TAVR. Euro Heart J Cardiovasc Imag. 2023;24:1052‐1061. doi:10.1093/ehjci/jead018
Leone PP, Pu M, Latib A, Herrmann HC. Is it too early to predict effective orifice area in the TAVR era? JACC Cardiovasc Imag. 2023;16(1):138‐139. doi:10.1016/j.jcmg.2022.10.025