Although transcatheter aortic valve implantation (TAVI) has gained widespread adoption, surpassing surgical prostheses in the United States, there is still limited understanding of the frequency and outcomes of reinterventions in patients with such prostheses.

This study reviewed reinterventions in patients who underwent TAVI from 2012 to 2019, utilizing data from the Society of Thoracic Surgeons (STS) database and Michigan’s Transcatheter Valve Therapy Registry. The analysis included the reintervention frequency and clinical outcomes, particularly examining the observed-to-expected mortality ratio based on the STS Predicted Risk of Mortality index. Among the 9,694 patients who received TAVI, 87 (0.90%) required reintervention, either through surgical transcatheter valve explantation with surgical aortic valve replacement (SAVR) or a second TAVI procedure (TAVI-in-TAVI). The SAVR group showed a higher STS-predicted mortality risk. The number of reintervention cases rose from zero in 2012-2013 to 26 by 2019, with the proportion of transcatheter prosthesis explants with SAVR increasing from 13% in 2013 to 65% in 2019. Self-expanding devices exhibited a higher reintervention rate due to a greater need for SAVR (0.58% versus 0.19%; p = 0.001). However, TAVI-in-TAVI rates were similar. For patients requiring SAVR, contraindications for TAVI-in-TAVI included unfavorable anatomy (75%), need for another cardiac surgery (29%), structural issues with the transcatheter prosthesis (18%), and endocarditis (12%). Thirty-day mortality was 15% for SAVR and 2% for TAVI-in-TAVI (p = 0.032), with an observed-to-expected mortality ratio of 1.8 and 0.3, respectively (p = 0.018).

The authors conclude that reintervention on transcatheter prostheses in the aortic position remains rare but is on the rise. The significant clinical impact of surgical explantation is emphasized, particularly in patients with self-expanding devices.

COMMENTARY:

One primary finding from Fukuhara et al.’s study is that, to date, the reintervention rate after TAVI remains low—under 1%—similar to other studies (1.4% in PARTNER II and 2.8% in SURTAVI). Additionally, reintervention occurs relatively soon after TAVI (median of 9.6 months). However, this low rate does not fully reflect the true incidence of structural deterioration or dysfunction of bioprostheses, nor their durability, as reintervention patients in this series were carefully selected. Therefore, age, frailty, and other considerations for reintervention candidates were not adequately captured in the study. Furthermore, there are limited studies on TAVI’s long-term outcomes (beyond 5 years), as short survival following TAVI initially limited assessments of long-term prosthesis durability. As TAVI indications expand to all surgical risk categories, we anticipate a rise in reintervention rates for these prostheses, and, consequently, more data on durability and true reintervention criteria.

Another key takeaway is that nearly half of patients needing reintervention required surgical explantation and replacement of the aortic prosthesis rather than a second TAVI. Notably, surgical mortality was high, around 15%, similar to other series. This elevated mortality, contrasting with lower surgical reintervention mortality for surgically implanted bioprostheses (<3%), underscores the technical challenge of this procedure. Possible explanations may include the high percentage of concomitant procedures (two-thirds of patients) and aortic root structure damage during explantation (one-third required aortic repair). Given these figures and knowing most patients needing concomitant procedures likely had other valvulopathies or ischemic heart disease prior to their first TAVI, raises the question of the most appropriate initial procedure for these patients. Additionally, surgical reintervention is technically challenging due to firm adhesions, not only at the aortic annulus (similar to conventional surgical prostheses) but also at the aortic root wall and sinotubular junction, especially with self-expanding prostheses, as evidenced by the high aortic repair rate in these cases.

These concerning reintervention outcomes highlight particular relevance in low-surgical-risk patients requiring definitive aortic stenosis treatment, whose life expectancy may exceed bioprosthesis durability. Both SAVR and TAVI offer excellent short-term prognoses in these patients, but in cases where a percutaneous prosthesis is chosen, future high-risk surgical reintervention may be necessary. While Fukuhara et al.’s study shows favorable short-term TAVI-in-TAVI outcomes, data beyond one year on this approach’s durability is lacking, and emerging evidence links it to accelerated structural deterioration and leaflet thrombosis. Thus, it is crucial for the Heart Team to consider these long-term challenges and risks when evaluating TAVI as an option in low-risk aortic stenosis patients, as it may offer initially favorable outcomes with potential future complications yet to be clarified.

The relationship found between self-expanding devices and higher reintervention rates lacks sufficient detail to draw significant conclusions. Although self-expanding prostheses continue to show favorable short-term outcomes, with low pacemaker implantation rates and paravalvular leakage, other questions remain unresolved. For instance, is there a higher risk of coronary obstruction during TAVI-in-TAVI procedures? Should we consider SAVR and concomitant coronary surgery for cases with difficult coronary artery access?

Indications for choosing SAVR over TAVI-in-TAVI typically include severe paravalvular leak, small prosthesis size with structural deterioration, unfavorable coronary anatomy, the need for concomitant procedures, and prosthetic endocarditis. Notably, the latter condition, with its exponential growth, is a rising concern, further elevating reintervention risk. Therefore, increased prosthetic endocarditis prevalence necessitates a multidisciplinary and personalized approach for patient management.

This study provides a comprehensive view of post-TAVI reinterventions, prompting a reevaluation of patient discussions regarding aortic stenosis interventions. Often overlooked, it is vital to address both short- and long-term risks and benefits of intervention options, whether TAVI or SAVR, especially in younger, low-risk patients, as the need for reintervention after a first transcatheter prosthesis may negatively impact their long-term prognosis.

REFERENCE:

Fukuhara S, Tanaka D, Brescia AA, Wai Sang SL, Grossman PM, et al. Aortic valve reintervention in patients with failing transcatheter aortic bioprostheses: A statewide experience. J Thorac Cardiovasc Surg. 2023 Jun;165(6):2011-2020.e5. doi: 10.1016/j.jtcvs.2021.08.057.