Comparative Quantitative Aortographic Assessment of Regurgitation in Patients Treated With VitaFlow Transcatheter Heart Valve Vs. Other Self-Expanding Systems

Overview

Journal Front Cardiovasc Med

Specialty Cardiology & Vascular Diseases

Date 2022 Feb 11

PMID 35146004

Authors

Rutao Wang

Hideyuki Kawashima

Chao Gao

Fangjun Mou

Ping Li

Junjie Zhang

Jian Yang

Jianfang Luo

Darren Mylotte

William Wijns

Yoshinobu Onuma

Osama Soliman

Ling Tao

Patrick W Serruys

Affiliations

Soon will be listed here.

Abstract

Objectives: To compare the quantitative angiographic aortic regurgitation (AR) of six self-expanding valves after transcatheter aortic valve replacement (TAVR).

Background: Quantitative videodensitometric aortography (LVOT-AR) is an accurate and reproducible tool for assessment of AR following TAVR.

Methods: This is a retrospective central core-lab analysis of 1,257 consecutive cine aortograms performed post-TAVR. The study included 107 final aortograms of consecutive patients who underwent TAVR with first-generation VitaFlow in four Chinese centers and 1,150 aortograms with five other transcatheter aortic valves (Evolut Pro, Evolut R, CoreValve, Venus A-Valve, and Acurate Neo). LVOT-AR analyses of these five valves were retrieved from a previously published pooled database.

Results: Among 172 aortograms of patients treated with VitaFlow, 107 final aortograms (62.2%) were analyzable by LVOT-AR. In this first in man eight cases necessitated a procedural valve in valve due to inappropriate TAVR positioning and severe aortic paravalvular regurgitation. In the VitaFlow group, the mean LVOT-AR of the intermediate aortograms was 7.3 ± 7.8% and the incidence of LVOT-AR >17% was 8.6%. The mean LVOT-AR of the final aortogram was 6.1 ± 6.4% in the VitaFlow group, followed by Evolut Pro (7.3 ± 6.5%), Evolut R (7.9 ± 7.4%), Venus A-valve (8.9 ± 10.0%), Acurate Neo (9.6 ± 9.2%), and lastly CoreValve (13.7 ± 10.7%) (analysis of variance < 0.001). Post hoc 2-by-2 testing showed that CoreValve had significantly higher LVOT-AR compared with each of the other five THVs. No statistical difference in LVOT-AR was observed between VitaFlow, Evolut Pro, Evolut R, Acurate Neo, and Venus A-valves. The VitaFlow system had the lowest proportion of patients with LVOT-AR >17% (4.7%) (AR after the final aortograms), followed by Evolut Pro (5.3%), Evolut R (8.8%), Acurate Neo (11.3%), Venus A-valve (14.2%), and CoreValve (30.1%) (chi-square < 0.001).

Conclusion: Compared to other commercially available self-expanding valves, VitaFlow seems to have a low degree of AR and a low proportion of patients with ≥moderate/severe AR as assessed by quantitative videodensitometric angiography. Once the learning phase is completed, comparisons of AR between different transcatheter heart valves should be attempted in a prospective randomized trial.

Citing Articles

Predictors for new-onset conduction block in patients with pure native aortic regurgitation after transcatheter aortic valve replacement with a new-generation self-expanding valve (VitaFlow Liberty): a retrospective cohort study.

Zhang X, Liang C, Zha L, Zuo Q, Hu G, Ding J BMC Cardiovasc Disord. 2024; 24(1):77.

PMID: 38281925 PMC: 10822180. DOI: 10.1186/s12872-024-03735-z.

N-terminal pro-B-type natriuretic peptide is associated with clinical outcomes after transcatheter aortic valve replacement.

Yu J, Wang W J Cardiothorac Surg. 2023; 18(1):286.

PMID: 37817246 PMC: 10566171. DOI: 10.1186/s13019-023-02391-2.

Short- to mid-term outcomes after transcatheter aortic valve replacement in patients with ascending aorta dilation: a single-centre retrospective analysis.

Yu J, Wang W BMC Cardiovasc Disord. 2023; 23(1):31.

PMID: 36650444 PMC: 9847094. DOI: 10.1186/s12872-023-03063-8.

References

Attizzani G, Ohno Y, Latib A, Petronio A, De Carlo M, Giannini C . Transcatheter Aortic Valve Implantation Under Angiographic Guidance With and Without Adjunctive Transesophageal Echocardiography. Am J Cardiol. 2015; 116(4):604-11. DOI: 10.1016/j.amjcard.2015.05.024. View

SELLERS R, Levy M, AMPLATZ K, Lillehei C . LEFT RETROGRADE CARDIOANGIOGRAPHY IN ACQUIRED CARDIAC DISEASE: TECHNIC, INDICATIONS AND INTERPRETATIONS IN 700 CASES. Am J Cardiol. 1964; 14:437-47. DOI: 10.1016/0002-9149(64)90027-x. View

Modolo R, Chang C, Abdelghani M, Kawashima H, Ono M, Tateishi H . Quantitative Assessment of Acute Regurgitation Following TAVR: A Multicenter Pooled Analysis of 2,258 Valves. JACC Cardiovasc Interv. 2020; 13(11):1303-1311. DOI: 10.1016/j.jcin.2020.03.002. View

Abdelghani M, Tateishi H, Miyazaki Y, Cavalcante R, Soliman O, Tijssen J . Angiographic assessment of aortic regurgitation by video-densitometry in the setting of TAVI: Echocardiographic and clinical correlates. Catheter Cardiovasc Interv. 2017; 90(4):650-659. DOI: 10.1002/ccd.26926. View

Abdelghani M, Miyazaki Y, de Boer E, Aben J, van Sloun M, Suchecki T . Videodensitometric quantification of paravalvular regurgitation of a transcatheter aortic valve: in vitro validation. EuroIntervention. 2017; 13(13):1527-1535. DOI: 10.4244/EIJ-D-17-00595. View

Kawashima H, Soliman O, Wang R, Ono M, Hara H, Gao C . Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial. Am Heart J. 2020; 232:23-38. DOI: 10.1016/j.ahj.2020.11.001. View

Otto C, Kumbhani D, Alexander K, Calhoon J, Desai M, Kaul S . 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults With Aortic Stenosis: A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2017; 69(10):1313-1346. DOI: 10.1016/j.jacc.2016.12.006. View

Modolo R, Chang C, Tateishi H, Miyazaki Y, Pighi M, Abdelghani M . Quantitative aortography for assessing aortic regurgitation after transcatheter aortic valve implantation: results of the multicentre ASSESS-REGURGE Registry. EuroIntervention. 2019; 15(5):420-426. DOI: 10.4244/EIJ-D-19-00362. View

Genereux P, Piazza N, Alu M, Nazif T, Hahn R, Pibarot P . Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021; 42(19):1825-1857. DOI: 10.1093/eurheartj/ehaa799. View

10.

Hahn R, Pibarot P, Weissman N, Rodriguez L, Jaber W . Assessment of paravalvular aortic regurgitation after transcatheter aortic valve replacement: intra-core laboratory variability. J Am Soc Echocardiogr. 2015; 28(4):415-22. DOI: 10.1016/j.echo.2015.01.007. View

11.

Miyazaki Y, Abdelghani M, de Boer E, Aben J, van Sloun M, Suchecki T . A novel synchronised diastolic injection method to reduce contrast volume during aortography for aortic regurgitation assessment: in vitro experiment of a transcatheter heart valve model. EuroIntervention. 2017; 13(11):1288-1295. DOI: 10.4244/EIJ-D-17-00355. View

12.

Schultz C, Slots T, Yong G, Aben J, van Mieghem N, Swaans M . An objective and reproducible method for quantification of aortic regurgitation after TAVI. EuroIntervention. 2014; 10(3):355-63. DOI: 10.4244/EIJY14M05_06. View

13.

Adams D, Popma J, Reardon M, Yakubov S, Coselli J, Deeb G . Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014; 370(19):1790-8. DOI: 10.1056/NEJMoa1400590. View

14.

Calabro P, Gragnano F, Niccoli G, Marcucci R, Zimarino M, Spaccarotella C . Antithrombotic Therapy in Patients Undergoing Transcatheter Interventions for Structural Heart Disease. Circulation. 2021; 144(16):1323-1343. DOI: 10.1161/CIRCULATIONAHA.121.054305. View

15.

Mack M, Leon M, Smith C, Miller D, Moses J, Tuzcu E . 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015; 385(9986):2477-84. DOI: 10.1016/S0140-6736(15)60308-7. View

16.

Tateishi H, Campos C, Abdelghani M, Leite R, Mangione J, Bary L . Video densitometric assessment of aortic regurgitation after transcatheter aortic valve implantation: results from the Brazilian TAVI registry. EuroIntervention. 2016; 11(12):1409-18. DOI: 10.4244/EIJV11I12A271. View

17.

Modolo R, Chang C, Onuma Y, Schultz C, Tateishi H, Abdelghani M . Quantitative aortography assessment of aortic regurgitation. EuroIntervention. 2019; 16(9):e738-e756. DOI: 10.4244/EIJ-D-19-00879. View

18.

Abdel-Wahab M, Abdelghani M, Miyazaki Y, Holy E, Merten C, Zachow D . A Novel Angiographic Quantification of Aortic Regurgitation After TAVR Provides an Accurate Estimation of Regurgitation Fraction Derived From Cardiac Magnetic Resonance Imaging. JACC Cardiovasc Interv. 2018; 11(3):287-297. DOI: 10.1016/j.jcin.2017.08.045. View

19.

Zhou D, Pan W, Wang J, Wu Y, Chen M, Modine T . VitaFlow™ transcatheter valve system in the treatment of severe aortic stenosis: One-year results of a multicenter study. Catheter Cardiovasc Interv. 2019; 95(2):332-338. DOI: 10.1002/ccd.28226. View

20.

Kawashima H, Wang R, Mylotte D, Jagielak D, De Marco F, Ielasi A . Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves. Glob Heart. 2021; 16(1):20. PMC: 7977026. DOI: 10.5334/gh.959. View