BACKGROUND: The axillary artery is an alternative route for patients with comorbidities and unfavorable femoral arteries who need transcatheter aortic valve replacement (TAVR). Simplified trans-axillary transcatheter aortic valve replacement (TAx-TAVR) implies a completely percutaneous approach under local anesthesia and arteriotomy closure with vascular closure techniques. Herein, we report on early experience with simplified TAx-TAVR under local anesthesia. METHODS: We enrolled all consecutive patients who underwent simplified TAx-TAVR in our center. Main study parameter was the incidence of axillary access related major vascular complications within 30 days. Secondary parameters included a composite early safety endpoint, axillary access-site related vascular/bleeding complications and short-term mortality. Post TAVR axillary stent patency was evaluated during follow-up by CT-analysis. RESULTS: Between July 2018 and April 2020, Tax-TAVR was attempted in 35 patients with a mean age of 79 years. Local anesthesia and conscious sedation were used in 91.4% (n = 32) and 8.6% (n = 3) respectively. A covered stent was needed for complete axillary hemostasis in 44.1% (n = 15). Device success was achieved in 91.2% (n = 31/34). The 30-day axillary artery major vascular and ≥major bleeding complication rates were 14% (n = 5) and 11% (n = 4). The early safety endpoint was reached in 22.9% (n = 8). Mortality rates at 30 days and six months were 2.9% and 11.6%. Computed tomography (CT) confirmed axillary stent patency during follow-up in 82% (n = 9/11). CONCLUSIONS: In patients with high/prohibitive surgical risk and unsuitable femoral access, simplified TAx-TAVR under local anesthesia offers a valuable alternative for transfemoral TAVR but requires advanced access site management techniques including covered stents. Our data suggest an unmet clinical need for dedicated TAx closure devices.
BACKGROUND: The axillary artery is an alternative route for patients with comorbidities and unfavorable femoral arteries who need transcatheter aortic valve replacement (TAVR). Simplified trans-axillary transcatheter aortic valve replacement (TAx-TAVR) implies a completely percutaneous approach under local anesthesia and arteriotomy closure with vascular closure techniques. Herein, we report on early experience with simplified TAx-TAVR under local anesthesia. METHODS: We enrolled all consecutive patients who underwent simplified TAx-TAVR in our center. Main study parameter was the incidence of axillary access related major vascular complications within 30 days. Secondary parameters included a composite early safety endpoint, axillary access-site related vascular/bleeding complications and short-term mortality. Post TAVR axillary stent patency was evaluated during follow-up by CT-analysis. RESULTS: Between July 2018 and April 2020, Tax-TAVR was attempted in 35 patients with a mean age of 79 years. Local anesthesia and conscious sedation were used in 91.4% (n = 32) and 8.6% (n = 3) respectively. A covered stent was needed for complete axillary hemostasis in 44.1% (n = 15). Device success was achieved in 91.2% (n = 31/34). The 30-day axillary artery major vascular and ≥major bleeding complication rates were 14% (n = 5) and 11% (n = 4). The early safety endpoint was reached in 22.9% (n = 8). Mortality rates at 30 days and six months were 2.9% and 11.6%. Computed tomography (CT) confirmed axillary stent patency during follow-up in 82% (n = 9/11). CONCLUSIONS: In patients with high/prohibitive surgical risk and unsuitable femoral access, simplified TAx-TAVR under local anesthesia offers a valuable alternative for transfemoral TAVR but requires advanced access site management techniques including covered stents. Our data suggest an unmet clinical need for dedicated TAx closure devices.