Outcomes with a latest generation self-expandable, intra-annular, re-sheathable transcatheter heart valve system: analysis of patients with impaired left ventricular function and determinants for pacemaker implantation

Clin Res Cardiol. 2018 Oct;107(10):914-923. doi: 10.1007/s00392-018-1263-x. Epub 2018 Apr 28.

Abstract

Objectives: We herein report a single-center experience with the Portico TAVI system. Main focus was set on outcomes in patients with impaired left ventricular (LV) function and predictors for permanent pacemaker (PPM) implantation.

Methods: Between 05/2014 and 10/2017, 106 consecutive patients received TAVI using the Portico device. For comparison of patients with/without impaired LV function, and determination of multi-slice computed tomography and electrocardiogram correlates for PPM implantation subgroups were built (Subgroup I: LVEF ≥ 50%, n = 69, Subgroup II: LVEF < 50%, n = 37; Subgroup A: no PPM implantation, n = 89; Subgroup B: PPM implantation, n = 17). Data were retrospectively analyzed.

Results: Device success was 95.3% (101/106) with resulting transvalvular peak/mean pressure gradients of 10.6 ± 5.6/5.4 ± 3.1 and PVL ≥ moderate in 5/106 patients (4.7%). 30-day mortality was 4.7% (5/106; subgroup I 3/69, 4.3%; subgroup II 2/37, 5.4%; p = 1.0). Regarding VARC-2 adjudicated clinical endpoints stroke (3/106, 2.8%; subgroups I/II: 2/69 vs. 1/37, p = 1.0) and acute kidney injury (9/106, 8.5%; subgroups I/II: 6/69 vs. 3/37, p = 1.0), no significant differences were found. Postprocedural PPM implantation occurred in 17.9% (19/106) of the patients. Logistic regression for PPM implantation demonstrated predictive character of left coronary cusp (LCC) calcium load in zone 1 (annular plane to coronary ostia) (p = 0.05, threshold 193 mm3) and total calcium load of zone 1 (p = 0.05, threshold 751.2 mm3).

Conclusions: The Portico valve demonstrates a satisfying safety outcome, especially for patients with impaired LV function. Results of the CE-mark trial were confirmed, except for higher PPM rates. PPM rates are in accordance with other reports on this TAVI platform.

Keywords: Self-expandable; TAVI; TAVR; Transcatheter valve therapy; Valve disease.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / surgery*
  • Echocardiography, Transesophageal
  • Electrocardiography
  • Female
  • Follow-Up Studies
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Multidetector Computed Tomography
  • Pacemaker, Artificial*
  • Prosthesis Design
  • Retrospective Studies
  • Transcatheter Aortic Valve Replacement / methods*
  • Treatment Outcome
  • Ventricular Function, Left / physiology*