Ultrasound Guidance to Reduce Vascular and Bleeding Complications of Percutaneous Transfemoral Transcatheter Aortic Valve Replacement: A Propensity Score-Matched Comparison

Abstract

Background Ultrasound (US) guidance provides the unique opportunity to control the puncture zone of the artery during transfemoral transcatheter aortic valve replacement and may decrease major vascular complications (VC) and life-threatening or major bleeding complications. This study aimed to evaluate the clinical impact of US guidance using a propensity score-matched comparison. Methods and Results US guidance was implemented as the default approach for all transfemoral transcatheter aortic valve replacement cases in our institution in June 2013. We defined 3 groups of consecutive patients according to the method of puncture (fluoroscopic/US guidance) and the use of a transcatheter heart valve. Patients in the US-guided second-generation group (Sapien XT [Edwards Lifesciences, Irvine, CA], Corevalve [Medtronic, Dublin, Ireland]) were successfully 1:1 matched with patients in the fluoroscope-guided second-generation group (n=95) with propensity score matching. In a second analysis we described the consecutive patients of the US-guided third-generation group (Evolut-R [Medtronic], Sapien 3 [Edwards Lifesciences], n=308). All vascular and bleeding complications were reduced in the US-guided second-generation group compared with the fluoroscope-guided second-generation group: VC (16.8% versus 6.3%; P=0.023); life-threatening or major bleeding (22.1% versus 6%; P=0.004); and VC related to vascular access (12.6% versus 4.2%; P=0.052). In the US-guided third-generation group the rates of major VC and life-threatening or major bleeding were 3.2% (95% CI, 1.6% to 5.9%) and 3.6% (95% CI, 1.8% to 6.3%). In the overall population (n=546), life-threatening or major bleeding was associated with a 1.7-fold increased mortality risk (P=0.02). Conclusions We demonstrated that US guidance effectively reduced VC and bleeding complications for transfemoral transcatheter aortic valve replacement and should be considered the standard puncture method. Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02628509.

Keywords: bleeding; fluoroscopy; transcatheter aortic valve replacement; ultrasound; vascular complications.

Figure 1

Study design. Fluo indicates fluoroscope; gen., generation; TAVR, transcatheter aortic valve replacement; THV, transcatheter heart valve; and US, ultrasound.

Figure 2

Schematic representation of ultrasound (US) survey required to localize the femoral bifurcation between the superficial femoral artery (SFA) and the profound femoral artery (PFA) to determine the ideal puncture zone: below the inguinal ligament (IL) (parallel strands of echogenic fibers), in the middle of the noncalcified anterior wall, and in the horizontal segment of the common femoral artery (CFA). Imaging in longitudinal (long‐axis) and/or transverse (short‐axis) views. *Calcification.

Figure 3

Vascular, bleeding, and periprocedural complications by fluoroscope‐guided or US‐guided vascular access. Propensity score–matching analysis. IQR indicates interquartile range; OR, odds ratio; RBC, red blood cells; and US, ultrasound.

Figure 4

Details of major and minor vascular complications according to fluoroscope‐guided or US‐guided vascular access: Propensity score matching analysis (relative areas of each pies are proportional to the total number of complications). AV indicates arteriovenous; and US, ultrasound.

Figure 5

Vascular complications rate in the fluoroscope‐guided second‐generation (propensity score–matched), US‐guided second‐generation (propensity score–matched), and US‐guided third‐generation population. *P<0.05; **P<0.01; ***P<0.001. US indicates ultrasound; and VC, vascular complications.