Vascular Access Site Complications Do Not Correlate With Large Sheath Diameter in TAVI Procedures With New Generation Devices

Abstract

Background: Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) are associated with morbidity and mortality. However, consistent predictors have not been identified yet. The size of the implantation sheath seems to play a role, though especially with new generation TAVI devices and their improved sheaths and delivery systems this remains uncertain.Objectives: This study aimed to determine the incidence and predictors of access site-related vascular complications (VC) in the era of new generation TAVI devices.Methods and Results: Four hundred consecutive patients receiving TAVI in an experienced tertiary care center were analyzed. VC occurred in 89 patients (22.25%) with the majority being minor VC (21%) and only 1.25% major VC. Possible predictors for VC were tested, and only peri-interventional dual antiplatelet therapy (DAPT) showed to be predictive for VC [OR 2.11 (95% CI 1.10–4.06, p = 0.025)]. The female gender [OR 0.75 (95% CI 0.44–1.3), p = 0.31], sheath to femoral artery ratio >1.05 [OR 1.18 (95% CI 0.66–2.08, p = 0.58)], calcification of the access site vessel [OR 0.83 (95% CI 0.48–1.42, p = 0.48)], known peripheral artery disease [OR 0.95 (95% CI 0.4–2.25, p = 0.9)], and BMI ≥ 25 kg/m2 [OR 0.69 (95% CI 0.41–1.19, p = 0–19)] were not predictive of VC. The larger sheath with 20 French even showed less VC than the smaller sheath with 16 French [OR 0.43 (95% CI 0.25–0.74, p = 0.002)].Conclusions: Overall, the rate of major and minor VC was low in this study population (for major VC: rate of 1.25%). Predefined risk factors were not associated with the occurrence of VC, except for peri-interventional treatment with DAPT. Especially, larger sheath size could not be identified as a predictor for VC in the setting of TAVI procedures performed with contemporary devices.

Impact of vascular complications after transcatheter aortic valve implantation. VASC‐OBSERVANT II sub‐study

“…Indeed, the increased rate of bleeding and requirement of blood transfusion herein observed among patients with major VC might be a determinant of increased mortality of these patients 27 . Consistently with the literature, in our cohort, the sheath size did not influence VC in the setting of TAVI procedures performed with contemporary devices 28 …”

“…27 Consistently with the literature, in our cohort, the sheath size did not influence VC in the setting of TAVI procedures performed with contemporary devices. 28…”

Computed tomography derived anatomical predictors of vascular access complications following transfemoral transcatheter aortic valve implantation: A systematic review

“…Twenty two (95.6%) studies assessed IFA calcification for predicting TAVI‐related vascular complications (Table ). Iliofemoral calcification location and severity were graded subjectively using semi‐quantitative methods in 20 (90.9%) studies 15,17–30,32,33,35–37 . Calcification was quantified objectively by applying predefined Hounsfield unit (HU) thresholds in 5 (22.7%) studies 25,28,31,34,35 and by measuring the maximum circumference and thickness of calcification in 2 (9.1%) studies 23,27 …”

“…Iliofemoral calcification location and severity were graded subjectively using semi‐quantitative methods in 20 (90.9%) studies. 15 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 32 , 33 , 35 , 36 , 37 Calcification was quantified objectively by applying predefined Hounsfield unit (HU) thresholds in 5 (22.7%) studies 25 , 28 , 31 , 34 , 35 and by measuring the maximum circumference and thickness of calcification in 2 (9.1%) studies. 23 , 27 …”

“…Iliofemoral calcification location and severity were graded subjectively using semiquantitative methods in 20 (90.9%) studies. 15,[17][18][19][20][21][22][23][24][25][26][27][28][29][30]32,33,[35][36][37] Calcification was quantified objectively by applying predefined Hounsfield unit (HU) thresholds in 5 (22.7%) studies 25,28,31,34,35 and by measuring the maximum circumference and thickness of calcification in 2 (9.1%) studies. 23,27 Nine (40.9%) studies identified a significant association between iliofemoral calcification and access-related complications.…”