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

J Am Heart Assoc. 2020 Mar 17;9(6):e014916. doi: 10.1161/JAHA.119.014916. Epub 2020 Mar 16.

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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Catheterization, Peripheral* / adverse effects
  • Catheterization, Peripheral* / mortality
  • Female
  • Femoral Artery / diagnostic imaging*
  • Femoral Artery / injuries
  • Fluoroscopy
  • Humans
  • Male
  • Postoperative Hemorrhage / etiology
  • Postoperative Hemorrhage / mortality
  • Postoperative Hemorrhage / prevention & control*
  • Propensity Score
  • Punctures
  • Radiography, Interventional* / adverse effects
  • Radiography, Interventional* / mortality
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Transcatheter Aortic Valve Replacement* / mortality
  • Treatment Outcome
  • Ultrasonography, Interventional* / adverse effects
  • Ultrasonography, Interventional* / mortality
  • Vascular System Injuries / etiology
  • Vascular System Injuries / mortality
  • Vascular System Injuries / prevention & control*

Associated data

  • ClinicalTrials.gov/NCT02628509