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. 2022 Dec;111(12):1325-1335.
doi: 10.1007/s00392-022-02011-4. Epub 2022 Mar 23.

TAVI in patients with low-flow low-gradient aortic stenosis-short-term and long-term outcomes

Julius Steffen  1   2 , Nikolas Reißig  1 , David Andreae  1 , Markus Beckmann  1 , Magda Haum  1 , Julius Fischer  1 , Hans Theiss  1 , Daniel Braun  1 , Martin Orban  1 , Konstantinos Rizas  1   2 , Sebastian Sadoni  3 , Michael Näbauer  1 , Sven Peterss  3 , Jörg Hausleiter  1   2 , Steffen Massberg  1   2 , Simon Deseive  4
Affiliations

TAVI in patients with low-flow low-gradient aortic stenosis-short-term and long-term outcomes

Julius Steffen et al. Clin Res Cardiol. 2022 Dec.

Abstract

Objectives: The study objective was to characterize different groups of low-flow low-gradient (LFLG) aortic stenosis (AS) and determine short-term outcomes and long-term mortality according to Valve Academic Research Consortium-3 (VARC-3) endpoint definitions.

Background: Characteristics and outcomes of patients with LFLG AS undergoing transcatheter aortic valve implantation (TAVI) are poorly understood.

Methods: All patients undergoing TAVI at our center between 2013 and 2019 were screened. Patients were divided into three groups according to mean pressure gradient (dPmean), ejection fraction (LVEF), and stroke volume index (SVi): high gradient (HG) AS (dPmean ≥ 40 mmHg), classical LFLG (cLFLG) AS (dPmean < 40 mmHg, LVEF < 50%), and paradoxical LFLG (pLFLG) AS (dPmean < 40 mmHg, LVEF ≥ 50%, SVi ≤ 35 ml/m2).

Results: We included 1776 patients (956 HG, 447 cLFLG, and 373 pLFLG patients). Most baseline characteristics differed significantly. Median Society of Thoracic Surgeons (STS) score was highest in cLFLG, followed by pLFLG and HG patients (5.0, 3.9 and 3.0, respectively, p < 0.01). Compared to HG patients, odds ratios for the short-term VARC-3 composite endpoints, technical failure (cLFLG, 0.76 [95% confidence interval, 0.40-1.36], pLFLG, 1.37 [0.79-2.31]) and device failure (cLFLG, 1.06 [0.74-1.49], pLFLG, 0.97 [0.66-1.41]) were similar, without relevant differences within LFLG patients. NYHA classes improved equally in all groups. Compared to HG, LFLG patients had a higher 3-year all-cause mortality (STS score-adjusted hazard ratios, cLFLG 2.16 [1.77-2.64], pLFLG 1.53 [1.22-193]), as well as cardiovascular mortality (cLFLG, 2.88 [2.15-3.84], pLFLG, 2.08 [1.50-2.87]).

Conclusions: While 3-year mortality remains high after TAVI in LFLG compared to HG patients, symptoms improve in all subsets after TAVI.

Keywords: Aortic stenosis; Low-flow low-gradient; TAVI; VARC-3.

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Conflict of interest statement

JS received speaker honoraria from AstraZeneca. DB received speaker honoraria from Abbott Vascular. MO received speaker honoraria and travel compensations from Abbott Medical, AstraZeneca, Abiomed, Bayer vital, BIOTRONIK, Bristol-Myers Squibb, CytoSorbents, Daiichi Sankyo Germany, Edwards Lifesciences Services, and Sedana Medical. JH received research support Abbott Vascular and Edwards Lifesciences. SD received speaker honoraria from AstraZeneca. All other authors report to have no conflicts of interests to declare.

Figures

Fig. 1
Fig. 1
Study flow chart All patients undergoing transcatheter aortic valve replacement for severe AS between 2013 and 2019 were screened. Patients with prior aortic valve replacement and patients with insufficient echocardiography data were excluded. Patients were divided into groups according to aortic valve flow patterns. Patients with normal-flow low-gradient AS were not included in the analysis. dPmean transvalvular pressure gradient, SVi stroke volume index, TAVI transcatheter aortic valve implantation
Fig. 2
Fig. 2
Technical and clinical outcomes Short-term outcomes (up to 30 days) for the two LFLG groups were compared to HG and compared to each other according to Valve Academic Research Consortium-3 (VARC-3) endpoints. The composite endpoints of a technical failure (consisting of procedural death, structural cardiac complications, conversion to open surgery, prosthesis dislocation, the use of a second valve prosthesis, or immediate vascular intervention or surgery) or device failure at 30 days (consisting of the composite endpoint technical failure, 30-day mortality, elevated pressure gradients or relevant paravalvular regurgitation on echocardiography, or vascular surgery/intervention at 30 days, stroke, relevant bleeding, acute kidney injury (AKI) and permanent pacemaker implantation) occurred at similar frequencies. However, there were differences in single components. a The 30-day mortality was significantly higher in cLFLG compared to HG. b For pLFLG patients, the risk of relevant bleeding or the necessity for vascular interventions were significantly increased in comparison to HG patients. c While pLFLG patients had a higher risk for bleeding and vascular intervention/surgery, cLFLG patients had a higher 30-day mortality. OR denotes odds ratio. AKI acute kidney injury, cLFLG classical low-flow low-gradient, dPmean, mean transvalvular pressure gradients, HG high gradient, pLFLG paradoxical low-flow low-gradient, VARC-3 valve academic research consortium-3
Fig. 3
Fig. 3
Mean transvalvular pressure gradients before and after TAVI The graph depicts the mean transvalvular pressure gradients before TAVI and at follow-up for each group. Mean pressure gradients were 48 [43–56] mmHg before and 11 [8–15] mmHg after TAVI for HG, 26 [20–32] mmHg before and 8 [6–11] mmHg after TAVI for cLFLG, and 28 [23–35] mmHg before and 9 [6–12] mmHg after TAVI for pLFLG. There was a significant reduction of dPmean after TAVI in all three groups (p < 0.01 for all). cLFLG classical low-flow low-gradient, dPmean mean transvalvular pressure gradients, HG high gradient, pLFLG paradoxical low-flow low-gradient, TAVI transcatheter aortic valve implantation
Fig. 4
Fig. 4
NYHA Class Outcomes Patients’ New York Heart Association (NYHA) class was assessed before and at the latest possible follow-up up to three years after TAVI. Colors indicate NYHA class per group. There was a reduction of at least one NYHA class after TAVI in 76.3% of all patients without a relevant between-group difference. cLFLG classical low-flow low-gradient, HG high gradient, NYHA New York heart association, pLFLG paradoxical low-flow low-gradient, TAVI transcatheter aortic valve implantation
Fig. 5
Fig. 5
Estimated mortality curves in the overall study population Kaplan–Meier curves depicting 3-year mortality after TAVI. a Estimated mortality rates were significantly different between groups at 1 year, 2 years and at 3 years. b Mortality curves were adjusted to the median STS-score (3.78). Adjusted hazard ratios (HR) showed significantly increased estimated mortality rates for classical and paradoxical LFLG compared to HG patients. cLFLG classical low-flow low-gradient, HG high gradient, pLFLG, paradoxical low-flow low-gradient, TAVI transcatheter aortic valve implantation
Fig. 6
Fig. 6
Estimated cardiovascular mortality at 3 years The cause of death was compared between the three groups in a competing risk analysis regarding cardiovascular mortality, which was more common in cLFLG and pLFLG patients. cLFLG classical low-flow low-gradient, HG high gradient, pLFLG paradoxical low-flow low-gradient, TAVI transcatheter aortic valve implantation
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