A 100% transfemoral TAVI approach was feasible with 99.8% success; facilitated TF-TAVI had similar procedural outcomes but higher 30-day mortality (4.4% vs 0.9%, p=0.002).
Does facilitated transfemoral TAVI compared to standard transfemoral TAVI affect 30-day mortality and procedural outcomes in patients with severe PAD undergoing TAVI?
A facilitated transfemoral TAVI strategy for patients with severe PAD is feasible and yields similar procedural success to standard transfemoral access, though it is associated with higher 30-day mortality due to higher baseline clinical risk.
Absolute Event Rate: 0% vs 0%
Abstract Background In patients with peripheral arterial disease (PAD) alternative access routes for transcatheter aortic valve implantation (TAVI) maybe associated with inferior procedural outcomes as compared to transfemoral (TF) access. We investigated feasibility and safety of a strategy of systematic ilio-femoral axis pre-treatment (facilitated TF-TAVI) in all consecutive patients with severe PAD undergoing TAVI at our center. Methods The 100% transfemoral strategy has been applied from December 2020 to all consecutive TAVI patients and we present results through to December 2024. Patients were divided into standard and facilitated TF-TAVI groups. The primary outcome was all-cause mortality at 30 days. The secondary outcomes include device success and major adverse cardiovascular events (MACE) defined as cardiovascular death, stroke/transient ischemic attack and major vascular complication according to VARC-3 definitions. Results Over the study period 1267 TAVIs for AS were performed, 1265 (99.8%) through TF access. In 2 cases (0.2%) TF access was not attempted and TAVI was performed via alternative route, both not due to obstructive ilio-femoral PAD. 7.1% patients (n=90) were in the facilitated TF-TAVI group (3.3% surgical femoral cutdown) and pre-treated with: 51.1% (n=46) percutaneous angioplasty (PTA), 40.0% (n=36) PTA with intravascular lithotripsy, 3.3% (n=3) PTA with stenting and 5.6% (n=5) "paving and cracking" technique. 100% of attempted TF-TAVIs resulted in successful valve delivery. The facilitated TF-TAVI group showed higher baseline risk than standard TF-TAVI (diabetes 38.9% vs 28.3%, p=0.03, prior myocardial infarction 26.7% vs 17.8%, p=0.04, higher creatinine 1.4 vs 1.2 mg/dL, p=0.03) and a higher STS score: 6.1 vs 5.2%, p=0.04, respectively.(Table 1) There was no significant difference between groups (facilitated vs standard, respectively) in rates of technical (96.7 vs 97%, p=0.85) and device success (88.9 vs 91.3%, p=0.45), in the overall incidence of major vascular (2.2 vs 1.3 %, p=0.45) or major cardiac structural complications (1.1 vs 1.1%, p=0.99) and 30-day MACE (5.6 vs 3.1%, p=0.2) (Table 2). Notably, however, facilitated TF-TAVI showed higher 30-day mortality as compared to standard TF-TAVI (4.4% vs 0.9%, p=0.002). Vessel pre-treatment was not significantly associated with device success on multivariate analysis (OR 0.88, 95%CI 0.42-1.8, p=0.72). Independent predictors of 30-day MACE were identified as low left ventricular ejection fraction (1.04, 95%CI 1.02-1.06, p=0.003) and STS score (OR 1.10, 95%CI 1.04-1.16, p0.001). Conclusions A 100% TF-TAVI strategy is feasible and facilitated TF-TAVI shows good procedural results comparable to standard TF-TAVI. Higher 30-day mortality despite similar procedural outcomes in facilitated TF-TAVI is due to the inherent elevated risk of patients with severe PAD as documented in previous studies. Randomized trials of facilitated TF-TAVI vs TAVI through alternative access are warranted.
Sclafani et al. (Sat,) reported a other. A 100% transfemoral TAVI approach was feasible with 99.8% success; facilitated TF-TAVI had similar procedural outcomes but higher 30-day mortality (4.4% vs 0.9%, p=0.002).