Acute Outcomes of a Latest Generation Self-expandable, Intra-annular, Re-sheathable Transcatheter Heart Valve: The Portico System in 107 Consecutive Patients

Objectives: Self-expandable (SE) transcatheter heart valves (THV) are indicated in patients suffering from severe aortic stenosis with narrow and/or severely calcified aortic root anatomy, who are not eligible for surgical aortic valve replacement. We herein report the largest single-center experience with the Portico system, a unique SE THV which is implanted intra-annularly and without the need for rapid ventricular pacing (RVP).

Methods: From 2014 through 2017, a total of 107 consecutive patients (64.5% female, 80.4 ± 6.4 years, log EuroSCORE I: 20.4 ± 15.6%, left ventricular ejection fraction [LVEF] ≤54%: 32.7%) received transfemoral (TF) transcatheter aortic valve implantation (TAVI) using the Portico THV. Data were retrospectively analyzed according to updated Valve Academic Research Consortium (VARC-2) definitions.

Results: Device success was 94.4% (101/107) and early combined safety 86.9% (93/107). All-cause 30-day mortality was 1.8% (2/107) including one patient with reduced LVEF. Resultant transvalvular peak/mean gradients and EOA were 15.1 ± 7.4/ 8.0 ± 4.2 and 2.2 ± 0.4 cm². PVL≥ moderate was observed in 0.9% (1/107). Rate of permanent pacemaker implantation was 16.8% (18/107), myocardial infarction 3.7% (4/107) and stroke 3.7% (4/107). Conscious sedation was utilized in 87.9% (94/107).

Conclusion: The Portico THV presents adequate hemodynamic and clinical results in our single-center patient cohort including a large proportion of patients with preoperative impaired LVEF. The intra-annular leaflet position and no requirement for RVP maintains hemodynamic stability during deployment, which is particularly favorable in patients with heart failure. The PPM rate is in accordance to other SE THV. These results have to be confirmed in larger patient numbers.