Comparing balloon-expandable and self-expanding transfemoral transcatheter aortic valve replacement based on subgroups in Germany 2019/2020.
Aortic valve stenosis
In-hospital mortality
National electronic health records
Subgroup analysis
Transcatheter aortic valve implantation
Transcatheter aortic valve replacement
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:
20 Nov 2023
20 Nov 2023
Historique:
received:
17
07
2023
accepted:
16
10
2023
medline:
20
11
2023
pubmed:
20
11
2023
entrez:
20
11
2023
Statut:
aheadofprint
Résumé
Previously, overall comparable outcomes were seen for balloon-expandable (BE) or self-expanding (SE) transfemoral transcatheter aortic valve replacement (TAVR). However, subgroup analyses based on large case numbers are still needed. German national data of all BE and SE transfemoral TAVR treating aortic valve stenosis in 2019 and 2020 were analysed. We then compared different outcomes and performed a subgroup analysis for the endpoint in-hospital mortality. Overall, 46,243 TAVR were analysed, 19,910 BE, and 26,333 SE. Patients in the SE group had a significantly higher logistic EuroSCORE (13.61 vs 12.66%, p < 0.001), age (81.55 vs 79.99a, p < 0.001), and proportion of women (54.82 vs 40.06%, p < 0.001). Both groups showed a similar in-hospital mortality with 2.37% in BE and 2.35% in SE (p = 0.916). In-hospital mortality also did not differ significantly after risk adjustment (OR = 0.98 [0.86, 1.13], p = 0.799). Patients in the SE group had a significantly lower risk of major bleeding (OR = 0.83 [0.73, 0.95], p = 0.006), but a significantly higher risk of stroke (OR = 1.38 [1.19, 1.59], p < 0.001), delirium (OR = 1.15 [1.06, 1.24], p = 0.001), and permanent pacemaker implantation (OR = 1.29 [1.21, 1.37], p < 0.001). In the subgroup analysis of in-hospital mortality, there were no significant differences in any of the observed subgroups (age < 75/75-79/80-84/ ≥ 85a, logistic EuroSCORE < 4/4- < 9/ ≥ 9, gender, NYHA III/IV, previous CABG, peripheral vascular disease, COPD, pulmonary hypertension, renal disease GFR < 30 ml/min, and diabetes mellitus). In the direct comparison of balloon-expandable and self-expanding TAVR, there are no differences for in-hospital mortality in subgroups.
Sections du résumé
BACKGROUND
BACKGROUND
Previously, overall comparable outcomes were seen for balloon-expandable (BE) or self-expanding (SE) transfemoral transcatheter aortic valve replacement (TAVR). However, subgroup analyses based on large case numbers are still needed.
METHODS
METHODS
German national data of all BE and SE transfemoral TAVR treating aortic valve stenosis in 2019 and 2020 were analysed. We then compared different outcomes and performed a subgroup analysis for the endpoint in-hospital mortality.
RESULTS
RESULTS
Overall, 46,243 TAVR were analysed, 19,910 BE, and 26,333 SE. Patients in the SE group had a significantly higher logistic EuroSCORE (13.61 vs 12.66%, p < 0.001), age (81.55 vs 79.99a, p < 0.001), and proportion of women (54.82 vs 40.06%, p < 0.001). Both groups showed a similar in-hospital mortality with 2.37% in BE and 2.35% in SE (p = 0.916). In-hospital mortality also did not differ significantly after risk adjustment (OR = 0.98 [0.86, 1.13], p = 0.799). Patients in the SE group had a significantly lower risk of major bleeding (OR = 0.83 [0.73, 0.95], p = 0.006), but a significantly higher risk of stroke (OR = 1.38 [1.19, 1.59], p < 0.001), delirium (OR = 1.15 [1.06, 1.24], p = 0.001), and permanent pacemaker implantation (OR = 1.29 [1.21, 1.37], p < 0.001). In the subgroup analysis of in-hospital mortality, there were no significant differences in any of the observed subgroups (age < 75/75-79/80-84/ ≥ 85a, logistic EuroSCORE < 4/4- < 9/ ≥ 9, gender, NYHA III/IV, previous CABG, peripheral vascular disease, COPD, pulmonary hypertension, renal disease GFR < 30 ml/min, and diabetes mellitus).
CONCLUSION
CONCLUSIONS
In the direct comparison of balloon-expandable and self-expanding TAVR, there are no differences for in-hospital mortality in subgroups.
Identifiants
pubmed: 37982864
doi: 10.1007/s00392-023-02326-w
pii: 10.1007/s00392-023-02326-w
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023. The Author(s).
Références
Stachon P, Hehn P, Wolf D, Heidt T, Oettinger V, Zehender M et al (2021) In-hospital outcomes of self-expanding and balloon-expandable transcatheter heart valves in Germany. Clin Res Cardiol 110(12):1977–1982
doi: 10.1007/s00392-021-01928-6
pubmed: 34546428
pmcid: 8639556
Thiele H, Kurz T, Feistritzer HJ, Stachel G, Hartung P, Eitel I et al (2020) Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial. Eur Heart J 41(20):1890–1899
doi: 10.1093/eurheartj/ehaa036
pubmed: 32049283
Deharo P, Bisson A, Herbert J, Lacour T, Saint Etienne C, Grammatico-Guillon L et al (2020) Impact of Sapien 3 balloon-expandable versus Evolut R self-expandable transcatheter aortic valve implantation in patients with aortic stenosis: data from a nationwide analysis. Circulation 141(4):260–268
doi: 10.1161/CIRCULATIONAHA.119.043971
pubmed: 31736332
Van Belle E, Vincent F, Labreuche J, Auffret V, Debry N, Lefèvre T et al (2020) Balloon-expandable versus self-expanding transcatheter aortic valve replacement: a propensity-matched comparison from the FRANCE-TAVI registry. Circulation 141(4):243–259
doi: 10.1161/CIRCULATIONAHA.119.043785
pubmed: 31736356
Vlastra W, Chandrasekhar J, Muñoz-Garcia AJ, Tchétché D, de Brito Jr FS, Barbanti M et al (2019) Comparison of balloon-expandable vs self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration. Eur Heart J 40(5):456–465
doi: 10.1093/eurheartj/ehy805
pubmed: 30590565
van Nieuwkerk AC, Santos RB, Andraka L, Tchetche D, de Brito FS, Barbanti M et al (2021) Balloon-expandable versus self-expandable valves in transcatheter aortic valve implantation: complications and outcomes from a large international patient cohort. J Clin Med 10(17):4005
doi: 10.3390/jcm10174005
pubmed: 34501454
pmcid: 8432462
van Nieuwkerk AC, Santos RB, Fernandez-Nofrerias E, Tchetche D, de Brito Jr FS, Barbanti M et al (2022) Outcomes in Valve-in-Valve Transcatheter Aortic Valve Implantation. Am J Cardiol 172:81–89
doi: 10.1016/j.amjcard.2022.02.028
pubmed: 35351288
Reinöhl J, Kaier K, Reinecke H, Schmoor C, Frankenstein L, Vach W et al (2015) Effect of availability of transcatheter aortic-valve replacement on clinical practice. N Engl J Med 373(25):2438–2447
doi: 10.1056/NEJMoa1500893
pubmed: 26672846
Stachon P, Kaier K, Zirlik A, Bothe W, Heidt T, Zehender M et al (2019) Risk-Adjusted Comparison of In-Hospital Outcomes of Transcatheter and Surgical Aortic Valve Replacement. J Am Heart Assoc 8(7):e011504
doi: 10.1161/JAHA.118.011504
pubmed: 30897991
pmcid: 6509703
Stachon P, Kaier K, Oettinger V, Bothe W, Zehender M, Bode C et al (2021) Transapical aortic valve replacement versus surgical aortic valve replacement: a subgroup analyses for at-risk populations. J Thoracic Cardiovasc Surg 162(6):1701–1709. e1
doi: 10.1016/j.jtcvs.2020.02.078
Habertheuer A, Gleason TG, Kilic A, Schindler J, Kliner D, Bianco V et al (2021) Outcomes of current-generation transfemoral balloon-expandable versus self-expandable transcatheter aortic valve replacement. Ann Thorac Surg 111(6):1968–1974
doi: 10.1016/j.athoracsur.2020.08.010
pubmed: 33045207
Abdel-Wahab M, Landt M, Neumann FJ, Massberg S, Frerker C, Kurz T et al (2020) 5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From the CHOICE Randomized Clinical Trial. JACC Cardiovasc Interv 13(9):1071–1082
doi: 10.1016/j.jcin.2019.12.026
pubmed: 32305398
Bruno F, D’Ascenzo F, Vaira MP, Elia E, Omede P, Kodali S et al (2021) Predictors of pacemaker implantation after transcatheter aortic valve implantation according to kind of prosthesis and risk profile: a systematic review and contemporary meta-analysis. Eur Heart J Qual Care Clin Outcomes 7(2):143–153
doi: 10.1093/ehjqcco/qcaa089
van Rosendael PJ, Delgado V, Bax JJ (2018) Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review. Eur Heart J 39(21):2003–2013
doi: 10.1093/eurheartj/ehx785
pubmed: 29420704
Abdel-Wahab M, Fujita B, Frerker C, Bauer T, Beckmann A, Bekeredjian R et al (2020) Transcatheter Versus Rapid-Deployment Aortic Valve Replacement. JACC Cardiovasc Interv 13(22):2642–2654
doi: 10.1016/j.jcin.2020.09.018
pubmed: 33213749
Rudolph TK, Herrmann E, Bon D, Walther T, Bauer T, Ensminger S, et al. Comparison of contemporary transcatheter heart valve prostheses: data from the German Aortic Valve Registry (GARY).Clin Res Cardiol 2023:1–11
Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J et al (2022) 2021 ESC/EACTS Guidelines for the management of valvular heart disease: developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 43(7):561–632
doi: 10.1093/eurheartj/ehab395
pubmed: 34453165
Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP, Gentile F et al (2021) 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 143(5):e72–e227
pubmed: 33332150
Oettinger V, Kaier K, Heidt T, Hortmann M, Wolf D, Zirlik A et al (2020) Outcomes of transcatheter aortic valve implantations in high-volume or low-volume centres in Germany. Heart 106(20):1604–1608
doi: 10.1136/heartjnl-2019-316058
pubmed: 32071092
Kaier K, Oettinger V, Reinecke H, Schmoor C, Frankenstein L, Vach W et al (2018) Volume-outcome relationship in transcatheter aortic valve implantations in Germany 2008–2014: a secondary data analysis of electronic health records. BMJ Open 8(7):e020204
doi: 10.1136/bmjopen-2017-020204
pubmed: 30056377
pmcid: 6067393
Schrage B, Becher PM, Gossling A, Savarese G, Dabboura S, Yan I et al (2021) Temporal trends in incidence, causes, use of mechanical circulatory support and mortality in cardiogenic shock. ESC Heart Fail 8(2):1295–1303
doi: 10.1002/ehf2.13202
pubmed: 33605565
pmcid: 8006704
Neumann JT, Gossling A, Sorensen NA, Blankenberg S, Magnussen C, Westermann D (2020) Temporal trends in incidence and outcome of acute coronary syndrome. Clin Res Cardiol 109(9):1186–1192
doi: 10.1007/s00392-020-01612-1
pubmed: 32034482
Freisinger E, Fuerstenberg T, Malyar NM, Wellmann J, Keil U, Breithardt G et al (2014) German nationwide data on current trends and management of acute myocardial infarction: discrepancies between trials and real-life. Eur Heart J 35(15):979–988
doi: 10.1093/eurheartj/ehu043
pubmed: 24558113
Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P et al (2021) Valve academic research consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J 42(19):1825–1857
doi: 10.1093/eurheartj/ehaa799