Dataset Information

Transcatheter Aortic Valve Implantation with ACURATE neo: Results from the PROGRESS PVL Registry

ABSTRACT:

Objectives

The PROGRESS PVL registry evaluated transcatheter aortic valve implantation (TAVI) in patients treated with ACURATE neo, a supra-annular self-expanding bioprosthetic aortic valve.

Background

While clinical outcomes with TAVI are comparable with those achieved with surgery, residual aortic regurgitation (AR) and paravalvular leak (PVL) are common complications. The ACURATE neo valve has a pericardial sealing skirt designed to minimize PVL.

Methods

The primary endpoint was the rate of total AR over time, as assessed by a core echocardiographic laboratory. The study enrolled 500 patients (mean age: 81.8 ± 5.1 years; 61% female; mean baseline STS score: 6.0 ± 4.5%) from 22 centers in Europe and Canada; 498 patients were treated with ACURATE neo.

Results

The rate of ≥ moderate AR was 4.6% at discharge and 3.1% at 12 months; the rate of ≥ moderate PVL was 4.6% at discharge and 2.6% at 12 months. Paired analyses showed significant improvement in overall PVL between discharge and 12 months (P < 0.001); 64.6% of patients had no change in PVL grade, 24.9% improved, and 10.5% worsened. Patients also exhibited significant improvement in transvalvular gradient (P < 0.001) and effective orifice area (P=0.01). The mortality rate was 2.2% at 30 days and 11.3% at 12 months. The permanent pacemaker implantation (PPI) rate was 10.2% at 30 days and 12.2% at 12 months.

Conclusions

Results from PROGRESS PVL support the sustained safety and performance of TAVI with the ACURATE neo valve, showing excellent valve hemodynamics, good clinical outcomes, and significant interindividual improvement in PVL from discharge to 12-month follow-up.

SUBMITTER: Kim W

PROVIDER: S-EPMC9252754 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionSevere complications after transcatheter aortic valve implantation (TAVI) are rare due to increasing procedural safety. However, TAVI procedure-related haemodynamic instability and increased risk of infection may affect renal functional reserve with subsequent renal acidosis and hyperkalaemia.ObjectiveIn this study, we investigated incidence, modifiable risk factors and prognosis of acute kidney injury (AKI) and AKI complicated by hyperkalaemia, pulmonary oedema or metabolic acidosis after TAVI.MethodsIn a retrospective single-centre study, 804 consecutive patients hospitalized during 2017 and 2018 for elective TAVI were included. AKI was defined according to the 'Kidney Disease Improving Global Outcome' (KDIGO) initiative. Variables on co-morbidities, intra-/post-interventional complications and course of renal function up to 6 months after index-hospitalization were assessed. In multivariate regression analyses, risk factors for the development of AKI, complicated AKI, renal non-recovery from AKI and in-hospital mortality were determined.ResultsIncidence of AKI was 13.8% (111/804); in-hospital mortality after TAVI was 2.3%. AKI was an independent risk factor for in-hospital mortality, odds ratio (OR) 10.3 (3.4-31.6), P < 0.001, further increasing to OR = 21.8 (6.6-71.5), P < 0.001 in patients with AKI complicated by hyperkalaemia, pulmonary oedema or metabolic acidosis, n = 57/111 (51.4%). Potentially modifiable, interventional factors independently associated with complicated AKI were infection [OR = 3.20 (1.61-6.33), P = 0.001] and red blood cell transfusion [OR = 5.04 (2.67-9.52), P < 0.001]. Valve type and size, contrast volume and other intra-interventional characteristics, such as the need for tachycardial pacing, did not influence the development of AKI. Eleven of 111 (9.9%) patients did not recover from AKI, mostly affecting patients with cardiac decompensation. In 18/111 (16.2%) patients, information concerning AKI was provided in discharge letter. Within 6 months after TAVI, higher proportion of patients with AKI showed progression of pre-existing chronic kidney disease compared with patients without AKI [14/29, 48.3% versus 54/187, 28.9%, OR = 2.3 (95% confidence interval 1.0-5.1), P = 0.036].ConclusionsAKI is common and may impede patient outcome after TAVI with acute complications such as hyperkalaemia or metabolic acidosis and adverse renal function until 6 months after intervention. Our study findings may contribute to refinement of allocation of appropriate level of care in and out of hospital after TAVI.