Long-Term Clinical Outcomes of Transcatheter Aortic Valve Replacement Using J-Valve System for Patients with Pure Native Aortic Regurgitation
DOI:
https://doi.org/10.59958/hsf.7983Keywords:
transcatheter aortic valve replacement, pure native aortic regurgitation, long-term follow-up, structural valve deteriorationAbstract
Background: The J-Valve, an “on-label” transcatheter heart valve, has been used for over a decade in patients with pure native aortic regurgitation (PNAR); however, long-term follow-up outcomes have not yet been documented. This study aims to evaluate the long-term safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with PNAR. Methods: We retrospectively reviewed 36 patients with PNAR who underwent TAVR using the J-Valve. Clinical data were collected, and follow-up assessments were performed via telephone or during outpatient visits. Results: The median follow-up duration was 5.26 years, and the cumulative 5-year survival rate was 74.0%. The initial procedural success rate of the J-Valve was remarkably high at 94.44%. There was no significant morphological or hemodynamic structural valve deterioration observed among these patients. Only one patient experienced moderate paravalvular leakage, which required surgical aortic valve replacement 4 years after the TAVR. Additionally, no instances of moderate or severe intra-prosthetic regurgitation were detected in this cohort. A significant reduction in left ventricular end-diastolic dimension was observed during the follow-up period compared to pre-operative measurements (p < 0.001). Conclusions: The J-Valve exhibited favorable long-term clinical outcomes, robust valve durability, and optimal hemodynamic performance in patients with PNAR.
References
Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP, 3rd, Gentile F, 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. Circulation. 2021; 143: e35–e71.
Mack MJ, Leon MB, Thourani VH, Pibarot P, Hahn RT, Genereux P, et al. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years. The New England Journal of Medicine. 2023; 389: 1949–1960.
Didier R, Eltchaninoff H, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, et al. Five-Year Clinical Outcome and Valve Durability After Transcatheter Aortic Valve Replacement in High-Risk Patients. Circulation. 2018; 138: 2597–2607.
de Freitas Campos Guimarães L, Urena M, Wijeysundera HC, Munoz-Garcia A, Serra V, Benitez LM, et al. Long-Term Outcomes After Transcatheter Aortic Valve-in-Valve Replacement. Circulation. Cardiovascular Interventions. 2018; 11: e007038.
Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, et al. 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: 2477–2484.
Wernly B, Eder S, Navarese EP, Kretzschmar D, Franz M, Alushi B, et al. Transcatheter aortic valve replacement for pure aortic valve regurgitation: “on-label” versus “off-label” use of TAVR devices. Clinical Research in Cardiology. 2019; 108: 921–930.
Shi J, Wei L, Chen Y, Wang X, Ye J, Qin C, et al. Transcatheter Aortic Valve Implantation With J-Valve: 2-Year Outcomes From a Multicenter Study. The Annals of Thoracic Surgery. 2021; 111: 1530–1536.
Luo X, Wang X, Li X, Wang X, Xu F, Liu M, et al. Transapical transcatheter aortic valve implantation using the J-Valve system: A 1-year follow-up study. The Journal of Thoracic and Cardiovascular Surgery. 2017; 154: 46–55.
Tung M, Wang X, Li F, Wang H, Guo Y, Wang C, et al. A versatile transapical device for aortic valvular disease: One-year outcomes of a multicenter study on the J-Valve system. Journal of Cardiology. 2018; 72: 377–384.
Li F, Wang X, Wang Y, Xu F, Wang X, Li X, et al. Structural Valve Deterioration after Transcatheter Aortic Valve Implantation Using J-Valve: A Long-Term Follow-Up. Annals of Thoracic and Cardiovascular Surgery. 2020; 26: 158–165.
Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal. 2017; 38: 3382–3390.
Noble S, Mauler-Wittwer S. TAVR as an Alternative to SAVR for Pure Native Aortic Regurgitation. The Canadian Journal of Cardiology. 2024; 40: 316–325.
De Backer O, Pilgrim T, Simonato M, Mackensen GB, Fiorina C, Veulemanns V, et al. Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation. The American Journal of Cardiology. 2018; 122: 1028–1035.
Vora AN, Sreenivasan J, Forrest JK. Progressing Forward in Transcatheter Aortic Valve Replacement for Pure Aortic Regurgitation. JACC. Cardiovascular Interventions. 2023; 16: 1986–1989.
Franzone A, Piccolo R, Siontis GCM, Lanz J, Stortecky S, Praz F, et al. Transcatheter Aortic Valve Replacement for the Treatment of Pure Native Aortic Valve Regurgitation: A Systematic Review. JACC. Cardiovascular Interventions. 2016; 9: 2308–2317.
Takagi H, Hari Y, Kawai N, Ando T. Meta-Analysis and Meta-Regression of Transcatheter Aortic Valve Implantation for Pure Native Aortic Regurgitation. Heart, Lung & Circulation. 2020; 29: 729–741.
Poletti E, De Backer O, Scotti A, Costa G, Bruno F, Fiorina C, et al. Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: The PANTHEON International Project. JACC. Cardiovascular Interventions. 2023; 16: 1974–1985.
Vahl TP, Thourani VH, Makkar RR, Hamid N, Khalique OK, Daniels D, et al. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. Lancet. 2024; 403: 1451–1459.
Liu H, Yang Y, Wang W, Zhu D, Wei L, Guo K, et al. Transapical transcatheter aortic valve replacement for aortic regurgitation with a second-generation heart valve. The Journal of Thoracic and Cardiovascular Surgery. 2018; 156: 106–116.
Haddad A, Arwani R, Altayar O, Sawas T, Murad MH, de Marchena E. Transcatheter aortic valve replacement in patients with pure native aortic valve regurgitation: A systematic review and meta-analysis. Clinical Cardiology. 2019; 42: 159–166.
Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Bärwolf C, Levang OW, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal. 2003; 24: 1231–1243.
Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. The New England Journal of Medicine. 2011; 364: 2187–2198.
Garcia S, Ye J, Webb J, Reardon M, Kleiman N, Goel S, et al. Transcatheter Treatment of Native Aortic Valve Regurgitation: The North American Experience With a Novel Device. JACC. Cardiovascular Interventions. 2023; 16: 1953–1960.
Mentias A, Saad M, Menon V, Reed GW, Popovic Z, Johnston D, et al. Transcatheter vs Surgical Aortic Valve Replacement in Pure Native Aortic Regurgitation. The Annals of Thoracic Surgery. 2023; 115: 870–876.
Alharbi AA, Khan MZ, Osman M, Khan MU, Munir MB, Syed M, et al. Transcatheter Aortic Valve Replacement vs Surgical Replacement in Patients With Pure Aortic Insufficiency. Mayo Clinic Proceedings. 2020; 95: 2655–2664.
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