Clinical impact and determinants of crossover from local anesthesia to conscious sedation during transfemoral TAVI: a subanalysis from the randomized DOUBLE-CHOICE Trial

Background The DOUBLE-CHOICE trial showed that a sedation-free minimalist strategy for transfemoral TAVI is noninferior to standard of care (SoC), but approximately 20% of patients required intra-procedural crossover. The clinical profile and prognostic implications of such conversion are unclear. Purpose To analyze the clinical impact and determinants of crossover from local anesthesia to conscious sedation during transfemoral TAVI. Methods This subanalysis included all 370 patients randomized to the minimalist approach (including local anesthesia only) in DOUBLE-CHOICE. Crossover to SoC was defined as any systemic administration of sedative or anesthetic medication during the procedure. Outcomes at 30 days were compared between patients who completed TAVI under local anesthesia and those undergoing crossover. Multivariable logistic regression assessed the independent association between crossover and the primary composite endpoint (death, vascular and bleeding complications, infections requiring antibiotics, and neurologic events) and identified baseline predictors of crossover. Results Overall, 72 of 370 patients (19.5%) required crossover. Baseline characteristics were generally similar, although prior stroke was more frequent among crossover patients. Crossover was associated with longer procedure times, greater use of invasive adjuncts, and lower technical (83.3% vs 98.0%) and device success (67.2% vs 87.5%; both p<0.001). The primary endpoint occurred in 38.7% of crossover versus 18.9% of non-crossover patients (odds ratio [OR] 2.7; 95% CI 1.5–4.9; p<0.001). Delirium was also more common after crossover (14.3% vs 3.6%; OR 4.5; 95% CI 1.7–12; p=0.003). In multivariable analysis, crossover remained independently associated with the primary endpoint (adjusted OR 3.28; 95% CI 1.60–6.70; p=0.001). Moderate-to-severe frailty and study center were independent predictors of crossover. Conclusions In sedation-free transfemoral TAVI, intra-procedural crossover to SoC occurs in one in five patients and is associated with adverse 30-day outcomes. Crossover should be regarded as a marker of procedural vulnerability rather than a benign deviation from a minimalist strategy.