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Vascular Complications in the Sapien 3 Era: Continued Role of Transapical Approach to TAVR
William Toppen, Cayley Bowles, Peyman Benharash, Olcay Aksoy, William Suh, *Richard J Shemin, *Murray Kwon
UCLA Medical School, Los Angeles, CA

Objective: With the introduction of the latest generation Sapien 3 transcatheter aortic valve, there has been a reduction in the usage of transapical (TA) approach for TAVRs in many centers. However, despite the smaller sheath size and more stream-lined delivery system, vascular complications continue to occur, especially in patients with peripheral vascular disease. Thus, our institution has maintained a stringent TA protocol aiming to prevent these complications. We hypothesize that this protocol has helped to reduce vascular complications and improve outcomes at our institution even in the Sapien 3 era.
Methods: All TAVR procedures done at our institution were considered for analysis. Patients were grouped according to whether their procedure was done before (Pre-S3) or after (S3) the introduction of the Sapien 3 valve as well as whether they underwent a transapical or transfemoral (TF) approach. Femoral artery intraluminal diameter of <7.5mm in the Pre-S3 era and <5.5mm in the S3 era with circumferential calcifications triggered TA approach consideration. Vascular complications included vascular perforation, dissection, flow-limiting stenosis, unplanned vascular surgery, significant post-procedural bleeding, hematoma at access site, and retroperitoneal bleed. Welch's t-test of unequal variance and chi-squared tests were used as appropriate. An alpha of <0.05 was considered significant.
Results: 275 total patients were included in the analysis (121 Pre-S3, 154 S3). TA approach was utilized in 45% of Pre-S3 Era vs. 15% in the S3 Era (p<0.001). Within the S3 era, 131 underwent TF approach compared to 23 undergoing TA. TA and TF patients were similar in all preoperative characteristics except hypertension (Table 1). Mortality was significantly lower in the S3 era (0% vs 4% in the pre-S3 era, p=0.02). Overall rates of vascular complications were similar between the Pre-S3 and S3 eras (15.7% vs 13.5%, p=0.63). Overall adverse outcomes were similar between TA and TF groups. TA patients saw significantly longer intensive care unit (ICU) and total hospital stay (Table 2).
Conclusions: Our results show that despite a smaller sheath size, vascular complications continue at a similar rate into the Sapien 3 era. This occurred in the setting of an ongoing aggressive TA utilization in select patients, specifically those with peripheral vascular disease. Maintaining this approach is likely a large contributor to both our current success and reduced mortality.
Table 1. Sapien 3 Era Patient Characteristics

Patient CharacteristicsTotal
N=154
TF
N=131
TA
N=23
P-value
Age, (mean SD), years80 1180 1282 100.36
Female, n (%)74 (48)61 (47)13 (57)0.39
BMI, (mean SD), kg/m226.6 5.726.8 5.925.8 3.90.32
Ejection Fraction, (mean SD)55 1555 1555 170.90
STS Risk Score, (mean SD)7.3 4.77.1 4.78.7 4.70.13
Hypertension, n (%)128 (83)106 (81)22 (97)0.01
Diabetes Mellitus, n (%)42 (27)36 (27)6 (26)0.89
Preop Creatinine, (mean SD)1.4 1.11.4 1.11.5 1.20.61
Dialysis, n (%)10 (6)8 (6)2 (9)0.69
Smoker, n (%)6 (4%)5 (4)1 (4)0.91
Table 2. Sapien 3 Era Outcomes
Outcomes in Sapien 3 EraTotal
N=154
TF
N=131
TA
N=23
P-value
Mortality, n (%)0 (0)0 (0)0 (0)N/A
Major Vascular Complications, n (%)21 (14)19 (15)2 (9)0.40
MACE, n (%)6 (4)4 (3)2 (9)0.37
Length of Stay, mean SD5.9 7.55.5 7.88.3 5.10.03
ICU Hours, mean SD44 6538 6484 110.001
MACE; major adverse cardiac outcomes


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