Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry

Abstract

A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a Portico™ transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav™ DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico™ THV at 30 days. The study collected ‘standard-of-care’ clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single Portico™ THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm2 and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The Portico™ THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico™ THV with either the first-generation DS or FlexNav™ DS.

Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry

“…The baseline and procedural characteristics of subjects from the CONFIDENCE registry have been recently reported. 6 Baseline characteristics are listed in Table 1 . Subject mean age was 82.0 ± 5.3 years, 62.5% were female, mean Society of Thoracic Surgeons score was 4.19, and 63.7% were in NYHA class III/IV ( Table 1 ).…”

“…Besides the low PVL rate that has been published recently, 6 an important factor that might have contributed to the low mortality is the excellent hemodynamic outcome of all valve sizes. The gradients were in the single-digit range even in patients with a very small annulus who had been treated with the 23-mm valve.…”

“…An independent clinical events committee (Cardiovascular Research Foundation, NY, USA) adjudicated all mortality endpoints according to Valve Academic Research Consortium-2 (VARC-2) guidelines. 6 Implant success was defined as absence of procedural mortality and correct positioning of a single Portico THV in the proper anatomical location. Thirty-day echocardiograms were evaluated by an independent echocardiographic core laboratory (MedStar Health Research Institute, Washington, DC, USA).…”

“…Paravalvular leak (PVL) was classified into 4 classes (none/trace, mild, moderate, and severe), and patient-prosthesis mismatch was classified into 3 classes (absent/insignificant, moderate, and severe) according to VARC-2 guidelines. 6 Patient-prosthesis mismatch was considered hemodynamically absent/insignificant if the indexed effective orifice area was >0.85 cm 2 /m 2 , moderate if between 0.65 and 0.85 cm 2 /m 2 , and severe if <0.65 cm 2 /m 2 . For obese patients with a body mass index 30 kg/m 2 , lower criteria were used per the VARC-2 guidelines.…”

“…For obese patients with a body mass index 30 kg/m 2 , lower criteria were used per the VARC-2 guidelines. 6 …”