Key result
The need for peripheral vascular intervention during TF-TAVR was not associated with a significantly higher risk of death compared to TF-TAVR without PVI (adjusted HR 0.96).
Why the study?
Peripheral vascular intervention is occasionally required to facilitate delivery system insertion or treat vascular complications during TF-TAVR, but its impact on outcomes is not well understood.
Does the need for peripheral vascular intervention during transfemoral TAVR worsen short- and intermediate-term clinical outcomes compared to uncomplicated TF-TAVR or non-transfemoral alternative access?
Cohort (n=2,386)
No
Does the need for peripheral vascular intervention during transfemoral TAVR worsen short- and intermediate-term clinical outcomes compared to uncomplicated TF-TAVR or non-transfemoral alternative access?
Hazard Ratio: 0.96 (95% CI 0.58–1.58)
Absolute Event Rate: 15.4% vs 20.7%
p-value: p=0.88
Requiring peripheral vascular intervention during transfemoral TAVR does not worsen patient prognosis compared to uncomplicated transfemoral TAVR, and remains superior to using alternative non-transfemoral access.
PVI during TF-TAVR was not associated with higher mortality; this Level 3 finding leaves open its influence on access-site decisions.
Background Peripheral vascular intervention (PVI) is occasionally required to facilitate delivery system insertion or to treat vascular complications during transfemoral transcatheter aortic valve replacement (TF‐TAVR). However, the impact of PVI on outcomes is not well understood. Therefore, we aimed to compare outcomes between TF‐TAVR with versus without PVI and between TF‐TAVR with PVI versus non‐TF‐TAVR. Methods and Results We retrospectively reviewed 2386 patients who underwent TAVR with a balloon‐expandable valve at a single institution from 2016 to 2020. The primary outcomes were death and major adverse cardiac/cerebrovascular event (MACCE), defined as death, myocardial infarction, or stroke. Of 2246 TF‐TAVR recipients, 136 (6.1%) required PVI (89% bailout treatment). During follow‐up (median 23.0 months), there were no significant differences between TF‐TAVR with and without PVI in death (15.4% versus 20.7%; adjusted HR [aHR], 0.96 [95% CI, 0.58–1.58]) or MACCE (16.9% versus 23.0%; aHR, 0.84 [95% CI, 0.52–1.36]). However, compared with non‐TF‐TAVR (n=140), TF‐TAVR with PVI carried significantly lower rates of death (15.4% versus 40.7%; aHR, 0.42 [95% CI, 0.24–0.75]) and MACCE (16.9% versus 45.0%; aHR, 0.40 [95% CI, 0.23–0.68]). Landmark analyses demonstrated lower outcome rates following TF‐TAVR with PVI than non‐TF‐TAVR both within 60 days (death 0.7% versus 5.7%, P =0.019; MACCE 0.7% versus 9.3%; P =0.001) and thereafter (death 15.0% versus 38.9%, P =0.014; MACCE 16.5% versus 41.3%, P =0.013). Conclusions The need for PVI during TF‐TAVR is not uncommon, mainly due to the bailout treatment for vascular complications. PVI is not associated with worse outcomes in TF‐TAVR recipients. Even when PVI is required, TF‐TAVR is associated with better short‐ and intermediate‐term outcomes than non‐TF‐TAVR.
No takes yet. Share an insight, caveat, or question.
Isogai et al. (2023) conducted a cohort in Severe aortic stenosis requiring transcatheter aortic valve replacement (n=2,386). Transfemoral transcatheter aortic valve replacement requiring peripheral vascular intervention vs. Transfemoral transcatheter aortic valve replacement without peripheral vascular intervention was evaluated on Death (adjusted HR 0.96, 95% CI 0.58–1.58, p=0.88). The need for peripheral vascular intervention during TF-TAVR was not associated with a significantly higher risk of death compared to TF-TAVR without PVI (adjusted HR 0.96).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: