Simplifying transfemoral ACURATE neo implantation using the TrueFlow nonocclusive balloon catheter

Catheter Cardiovasc Interv. 2020 Nov;96(6):E640-E645. doi: 10.1002/ccd.28741. Epub 2020 Jan 23.

Abstract

Objectives: This study aimed to investigate the safety and efficacy of ACURATE neo transcatheter aortic valve replacement (TAVR) facilitated by predilatation with the nonocclusive TrueFlow balloon catheter.

Background: Now that TAVR is moving forward, physicians have attempted to simplify and streamline the procedure and the so-called minimalist approach has become more popular.

Methods: We enrolled 142 patients (mean age: 82 ± 5 years, 61% female) in a prospective registry. Patients at low risk for intraprocedural third-degree atrioventricular block (AVB) underwent TAVR with the TrueFlow balloon without rapid pacing and without insertion of a provisional pacemaker (n = 121). The remaining 21 patients were predilated with rapid pacing using a provisional pacemaker and a standard balloon.

Results: Predilatation with the TrueFlow balloon was successful in all 121 patients. Postdilatation was less frequently required after predilatation with the TrueFlow (25% vs. 57%, p = .003). Moreover, median procedural duration with the TrueFlow was significantly shorter (42 [interquartile range, IQR: 34-53] vs. 55 [IQR: 46-61] min, p = .004). In-hospital outcomes were similar. At 30 days, there was no mortality, two (1%) patients had suffered a stroke and only four (3%) had required implantation of a new pacemaker.

Conclusion: Among patients with a low risk for intraprocedural third-degree AVB, the TrueFlow nonocclusive balloon catheter facilitates implantation of the ACURATE neo without the necessity of rapid pacing and a provisional pacemaker.

Keywords: aortic stenosis; conduction disorders; predilatation; procedure time; transcatheter aortic valve.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / physiopathology
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / surgery*
  • Atrioventricular Block / etiology
  • Atrioventricular Block / physiopathology
  • Atrioventricular Block / prevention & control
  • Balloon Valvuloplasty / adverse effects
  • Balloon Valvuloplasty / instrumentation*
  • Cardiac Catheters*
  • Catheterization, Peripheral* / adverse effects
  • Female
  • Femoral Artery*
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Prospective Studies
  • Prosthesis Design
  • Recovery of Function
  • Registries
  • Time Factors
  • Transcatheter Aortic Valve Replacement / adverse effects
  • Transcatheter Aortic Valve Replacement / instrumentation*
  • Treatment Outcome