Key result
Routine transfemoral TAVR using a minimalist approach with local anesthesia alone was feasible in 96.8% of patients, with 30-day mortality of 1.6% and stroke of 0.6%.
Why the study?
Procedural simplification has enabled a minimalist approach in transfemoral TAVR, but the feasibility and safety of routine local anesthesia without on-site anesthesiology support required assessment.
Is a minimalist transfemoral TAVR protocol with local anesthesia alone and no on-site anesthesiologist feasible and safe in patients undergoing TAVR?
Cohort (n=321)
No
Is a minimalist transfemoral TAVR protocol with local anesthesia alone and no on-site anesthesiologist feasible and safe in patients undergoing TAVR?
A minimalist transfemoral TAVR approach using only local anesthesia without an on-site anesthesiologist is highly feasible and safe, with low 30-day complication rates.
Hypothesis-generating for local anesthesia TAVR; leaves open randomized confirmation before practice change.
AIMS: Conscious sedation instead of general anesthesia has been increasingly adopted in many centers for transfemoral transcatheter aortic valve replacement (TAVR). Improvement of materials and operators' experience and reduction of periprocedural complications allowed procedural simplification and adoption of a minimalist approach. With this study, we sought to assess the feasibility and safety of transfemoral TAVR routinely performed under local anesthesia without on-site anesthesiology support. METHODS: The routine transfemoral TAVR protocol adopted at our center includes a minimalist approach, local anesthesia alone with fully awake patient, anesthesiologist available on call but not in the room, and direct transfer to the cardiology ward after the procedure. All consecutive patients undergoing transfemoral TAVR between January 2015 and July 2018 were included. We assessed the rates of actual local anesthesia-only procedures, conversion to conscious sedation or general anesthesia and 30-day clinical outcomes. RESULTS: Among 321 patients, 6 received general anesthesia upfront and 315 (98.1%) local anesthesia only. Mean age of the local anesthesia group was 83.2 ± 6.9 years, Society of Thoracic Surgery score 5.8 ± 4.8%. A balloon-expandable valve was used in 65.7%. Four patients (1.3%) shifted to conscious sedation because of pain or anxiety; 6 patients (1.9%) shifted to general anesthesia because of procedural complications. Hence, local anesthesia alone was possible in 305 patients (96.8% of the intended cohort, 95% of all transfemoral procedures). At 30 days, in the intended local anesthesia group, mortality was 1.6%, stroke 0.6%, major vascular complications 2.6%. Median hospital stay was 4 days (IQR 3-7). CONCLUSION: Transfemoral TAVR can be safely performed with local anesthesia alone and without an on-site anesthesiologist in the vast majority of patients.
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Saia et al. (2020) conducted a cohort in Transfemoral transcatheter aortic valve replacement (TAVR) (n=321). Minimalist transfemoral TAVR with local anesthesia alone was evaluated on Feasibility of local anesthesia alone (no conversion to conscious sedation or general anesthesia). Routine transfemoral TAVR using a minimalist approach with local anesthesia alone was feasible in 96.8% of patients, with 30-day mortality of 1.6% and stroke of 0.6%.
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