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Observational Study
. 2025 Jan 13;18(1):72-85.
doi: 10.1016/j.jcin.2024.09.039.

Hemodynamic Valve Deterioration After Transcatheter Aortic Valve Replacement: Incidence, Predictors, and Clinical Outcomes

Bashir Alaour  1 , Daijiro Tomii  2 , Masaaki Nakase  3 , Dik Heg  4 , Stefan Stortecky  3 , Jonas Lanz  3 , Daryoush Samim  3 , David Reineke  5 , Fabien Praz  3 , Stephan Windecker  3 , Thomas Pilgrim  6
Affiliations
Free article
Observational Study

Hemodynamic Valve Deterioration After Transcatheter Aortic Valve Replacement: Incidence, Predictors, and Clinical Outcomes

Bashir Alaour et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Reports on the durability of transcatheter aortic valve replacement (TAVR) prostheses are scarce and confounded by varying definitions and competing risks of death.

Objectives: The authors sought to determine the incidence, predictors, and clinical outcomes of hemodynamic valve deterioration (HVD) according to the Valve Academic Research Consortium 3 definition after TAVR.

Methods: We analyzed consecutive patients undergoing TAVR in the prospective Bern TAVI (Transcatheter Aortic Valve Implantation) registry between August 2007 and June 2022 for the incidence and predictors of HVD and performed case control-matching to compare outcomes according to HVD.

Results: A total of 2,403 eligible patients (mean age 81.8 ± 6.2 years, median Society of Thoracic Surgeons Predicted Risk of Mortality score 3.8% [Q1-Q3: 2.4%-6.0%]) were included and had a median duration of follow-up of 376 days (Q1-Q3: 365-1,825 days). The cumulative incidence of moderate or severe HVD was 2.2% (95% CI: 1.6%-3.1%), 10.8% (95% CI: 9.2%-12.7%), and 25.6% (95% CI: 17.5%-36.5%) at 1, 5, and 10 years, respectively. Aortic valve complex calcium volume (HR: 1.81; 95% CI: 1.11-2.97; P = 0.018), residual aortic regurgitation at discharge (HR: 1.87; 95% CI: 1.34-2.60; P < 0.001), and treatment with oral anticoagulants (HR: 1.78; 95% CI: 1.00-3.15; P = 0.048) were independent predictors of HVD. In the case control-matched cohort (HVD, n = 155, no-HVD, n = 600), patients with HVD had similar yearly rates of all-cause and cardiovascular mortality, and infective endocarditis, but higher rates of repeat aortic valve intervention (rate ratio [RR]: 4.81 [95% CI: 1.74-13.26]; P = 0.001).

Conclusions: HVD occurred in up to 1 in 4 patients throughout 10-year post-TAVR and was associated with a 5-fold increase in the risk of aortic valve reintervention.

Keywords: bioprosthetic valve failure; hemodynamic valve deterioration; transcatheter aortic valve replacement.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Alaour is supported by a British Cardiac Intervention Society BCIS International Structural Intervention Fellow, funded by Edwards Lifesciences through BCIS education fund; he does not receive any fund directly from Edwards Lifesciences. Dr Heg’s employer, CTU Bern, is involved in the design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern’s conflicts of interest see https://dcr.unibe.ch/services/terms__conditions/index_eng.html. Dr Stortecky has received institutional research grants from Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific; and has received speaker fees from Boston Scientific. Dr Lanz has received speaker fees from Edwards Lifesciences. Dr Samim has received funding for an online course from Edwards Lifesciences. Dr Praz has received travel expenses from Abbott, Edwards Lifesciences, and Polares Medical. Dr Windecker reports institutional research, travel, or educational grants without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, CorFlow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse Inc, Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, MedAlliance, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech. Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave. Dr Windecker has served as a advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to his institution; and has served as a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without personal remuneration. Dr Pilgrim has received institutional research, travel, or educational grants without personal remuneration from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens; has received institutional speaker fees and consultancy fees from Biotronik, Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, Biosensors, and Highlife. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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