Highlight
– Annual volumes of redo transcatheter aortic valve replacement (redo TAVR) and TAVR explant procedures have steadily increased between 2012 and 2024.
– Contemporary data show that redo TAVR predominates as the reintervention strategy beyond 5 years from initial TAVR.
– The annual incidence of TAVR reintervention increased from 0.17% in 2019 to 0.28% in 2023.
– Comprehensive evaluation includes valve-in-valve (ViV) TAVR and redo surgical aortic valve replacement (SAVR) defining broader trends of aortic valve reintervention.
Study Background and Disease Burden
Aortic valve replacement (AVR) is the definitive therapy for severe aortic valve diseases such as aortic stenosis or regurgitation. Transcatheter aortic valve replacement (TAVR) has become an increasingly preferred option, especially in adult patients at intermediate or high surgical risk. Since its introduction, TAVR has evolved dramatically, expanding to younger and lower-risk populations. Consequently, the need for valve reintervention due to structural valve deterioration, leaflet thrombosis, prosthesis-patient mismatch, or other complications has become an emerging concern.
Reintervention after TAVR typically occurs via two main approaches: redo TAVR (performing another transcatheter valve-in-valve implantation) or TAVR explant with surgical aortic valve replacement (SAVR). However, contemporary comprehensive data on the incidence and procedural volume of TAVR reinterventions remain limited, complicating efforts to optimize clinical decision-making and resource allocation.
Understanding the trends in procedural volumes and timing of reinterventions is critical to inform patient counseling, procedural risk assessment, and strategic planning for valve durability management in a growing population with prosthetic valves.
Study Design
This retrospective cohort analysis analyzed data from the US Centers for Medicare & Medicaid Services Virtual Research Data Center, examining procedural volumes and annual incidences of redo TAVR, TAVR explants, valve-in-valve (ViV) TAVR, and redo SAVR between January 2012 and June 2024.
The study population included patients with a history of prior aortic valve replacement via TAVR or SAVR who subsequently underwent another TAVR or SAVR procedure. The key exposure groups were defined as follows:
– Redo TAVR group: TAVR performed after a previous TAVR.
– TAVR explant group: SAVR performed after a prior TAVR, representing surgical removal of the transcatheter valve.
– Valve-in-valve (ViV) TAVR group: TAVR performed after previous SAVR.
– Redo SAVR group: SAVR performed after previous SAVR.
The primary outcomes were annual incidence and procedural volume of redo TAVR and TAVR explant operations. Secondary outcomes included similar metrics for ViV TAVR and redo SAVR.
Key Findings
From January 2012 to June 2024, a total of 410,720 TAVR procedures were identified. Among these, 2,374 were redo TAVRs and 1,346 were TAVR explants. Simultaneously, from 299,780 SAVRs performed in this period, there were 5,044 ViV TAVRs and 4,202 redo SAVRs.
Since 2020 alone, there has been a notable increase with 1,518 redo TAVRs and 1,007 TAVR explants performed, reflecting a rising need for reintervention in the growing population of TAVR recipients.
The annual incidence of TAVR reintervention has increased progressively from 0.17% in 2019 to 0.28% in 2023, signifying an expanding clinical challenge.
The temporal distribution of reinterventions revealed meaningful patterns:
– The most common time interval for redo TAVR following the index TAVR was within 3 months, accounting for 17.3% (410 of 2,374) of cases, likely reflecting early procedural failures or complications.
– For TAVR explant operations, the peak interval was 1 to 2 years post-index TAVR, constituting 19.2% (259 of 1,346) of cases, possibly related to early structural deterioration or complications necessitating valve removal.
– Notably, beyond 5 years after the index TAVR, redo TAVR was the predominant reintervention approach, comprising 88.5% (725 of 819) of reinterventions, suggesting growing clinical preference or feasibility of valve-in-valve techniques in late failures.
When examining broader aortic valve reintervention strategies, ViV TAVR after SAVR overtook redo SAVR in procedural numbers, indicating less invasive valve-in-valve approaches are favored across both primary TAVR and surgical cohorts.
Expert Commentary
The observed rise in redo TAVR and TAVR explant procedures reflects not only the expanding utilization of TAVR but also a maturing patient population requiring late valve management. The predominance of redo TAVR beyond 5 years underscores the procedural evolution toward less invasive reintervention methods, leveraging valve-in-valve technology to minimize surgical risks, especially in higher-risk or frail patients.
This shift is supported by emerging clinical data demonstrating acceptable safety and efficacy profiles for redo TAVR in selected patients. However, while redo TAVR offers procedural advantages, the durability of multiple transcatheter valves over extended periods remains under investigation. Surgical explant remains essential for managing cases with severe complications such as endocarditis, prosthetic valve failure unsuitable for valve-in-valve approaches, or complex anatomical challenges.
Study limitations include its retrospective design, reliance on administrative claims data which may miss granular clinical details (e.g., valve type, precise indication for reintervention), and potential confounding factors influencing procedure selection. Generalizability to non-Medicare populations or other healthcare systems may be limited.
Current guidelines recommend individualized assessment when considering redo TAVR versus surgical explant, taking into account patient anatomy, comorbidities, prosthesis characteristics, and center expertise. Future prospective studies and registries are needed to refine decision aid tools and optimize outcomes.
Conclusion
This large-scale, retrospective analysis reveals a clear trend toward increasing volumes and incidence of TAVR reinterventions in the contemporary era, paralleled by growing utilization of redo TAVR, especially beyond 5 years from the initial procedure. These findings highlight the importance of longitudinal management strategies for patients undergoing TAVR and support continued innovation and research into tailored reintervention approaches balancing durability, safety, and procedural invasiveness.
Clinicians should remain vigilant in monitoring TAVR recipients for late valve dysfunction, counsel patients about potential need for future interventions, and consider both redo TAVR and TAVR explant options within a patient-centered, multidisciplinary framework.
Further research efforts are critical to clarify best practices, develop risk stratification tools, and optimize procedural outcomes in this evolving landscape of aortic valve therapy.
References
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