scholarly journals Report on outcomes of valve-in-valve transcatheter aortic valve implantation and redo surgical aortic valve replacement in the Netherlands

Author(s):  
G. J. van Steenbergen ◽  
B. van Straten ◽  
K. Y. Lam ◽  
D. van Veghel ◽  
L. Dekker ◽  
...  

Abstract Objective We sought to investigate real-world outcomes of patients with degenerated biological aortic valve prostheses who had undergone valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) or reoperative surgical aortic valve replacement (redo-SAVR) in the Netherlands. Methods Patients who had undergone ViV-TAVI or redo-SAVR for a degenerated biological aortic valve prosthesis in the Netherlands between January 2014 and December 2018 were eligible for this retrospective study. Patients with a prior homograft, active endocarditis or mechanical aortic valve prosthesis were excluded. Patients were matched using the propensity score. The primary endpoint was a composite of 30-day all-cause mortality and in-hospital postoperative stroke. Secondary endpoints were all-cause mortality at different time points, in-hospital postoperative stroke, pacemaker implantation and redo procedures within one year. Baseline characteristics and outcome data were collected from the Netherlands Heart Registration. Results From 16 cardiac centres, 653 patients were included in the study (374 ViV-TAVI and 279 redo-SAVR). European System for Cardiac Operative Risk Evaluation I (EuroSCORE I) was higher in ViV-TAVI patients (19.4, interquartile range (IQR) 13.3–27.9 vs 13.8, IQR 8.3–21.9, p < 0.01). After propensity score matching, 165 patients were matched with acceptable covariate balance. In the matched cohorts, the primary endpoint was not significantly different for ViV-TAVI and redo-SAVR patients (odds ratio 1.30, 95% confidence interval 0.57–3.02). Procedural, 30-day and 1‑year all-cause mortality rates, incidence of in-hospital postoperative stroke, pacemaker implantation and redo procedures within one year were also similar between cohorts. Conclusion Patients with degenerated aortic bioprostheses treated with ViV-TAVI or redo-SAVR have similar mortality and morbidity.

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Pier Pasquale Leone ◽  
Damiano Regazzoli ◽  
Francesco Cannata ◽  
Matteo Pagnesi ◽  
Mauro Chiarito ◽  
...  

Abstract Aims In patients with severe aortic stenosis, trans-prosthetic haemodynamics after transcatheter aortic valve implantation (TAVI) tend to be more favourable than after surgical aortic valve replacement, especially after self-expandable valve (SEV) implantation. The relative performance of TAVI according to leaflet position, that is supra-annular and intra-annular valves (SAV and IAV, respectively), has not been investigated thoroughly. Moreover, prosthesis-patient mismatch (PPM) is more common in patients with small aortic annuli, even though its clinical impact after TAVI is debated. Compare haemodynamics and clinical outcomes of transcatheter SAV and IAV in patients with small annuli. Methods TAVI SMALL 2 is an international retrospective registry of 1378 patients with severe aortic stenosis and small annuli (annular perimeter &lt;72 mm or area &lt;400 mm2 on computed tomography) treated with transfemoral transcatheter SEV (Evolut R/Pro, n = 750, Acurate Neo, n = 170 and Portico n = 172) and balloon-expandable valves (BEV, Sapien 3, n = 286) in 16 high-volume centres. Analyses were performed according to mechanism of valve release, that is SEV (n = 1092) vs. BEV (n = 286), and according to leaflet position, that is SAV (Evolut R/Pro and Acurate Neo, n = 920) vs. IAV (Sapien 3 and Portico, n = 458). Primary endpoints were pre-discharge mean aortic gradient and incidence of severe PPM. Secondary endpoint was incidence of all-cause mortality. Results Pre-discharge mean aortic gradient was lower both after SAV vs. IAV (7.8 ± 3.9 vs. 12.0 ± 5.1, P &lt;0.001) and SEV vs. BEV implantation (8.0 ± 4.1 vs. 13.6 ± 4.7, P&lt;0.001). IAV implantation was more often complicated by severe PPM when compared to SAV implantation (8.8% vs. 3.6%, P = 0.007), and severe PPM was more common after BEV than after SEV implantation (8.7% vs. 4.6%, P = 0.041). At a median follow-up of 377 days (interquartile range 168–700 days), all-cause mortality occurred in 11.9% of patients after IAV and 9.4% after SAV implantation (P = 0.172), and in 12.3% and 9.8% of BEV and SEV groups, respectively (P = 0.218). Results were confirmed at Kaplan-Meier analysis (log-rank P = 0.748 and 0.687 for SAV vs. IAV and SEV vs. BEV, respectively, Figure 1). Pre-discharge more than mild paravalvular leak (PVL) was more common with SEV than BEV (11.6% vs. 2.6%, P &lt;0.001), while incidence of more than moderate PVL was higher both after SAV vs. IAV (1.5% vs. 0.2%, P = 0.043) and SEV vs. BEV implantation (1.4% vs. 0%, P = 0.052). New permanent pacemaker implantation was higher after SEV than BEV (13.5% vs. 8.1%, P = 0.013). Conclusions In this high-numerosity registry of patients with small aortic annuli, TAVI with SAV and SEV yielded a more favourable forward haemodynamic profile than after IAV and BEV implantation, respectively. All-cause mortality did not differ between groups.


Author(s):  
Helge Möllmann ◽  
David M. Holzhey ◽  
Michael Hilker ◽  
Stefan Toggweiler ◽  
Ulrich Schäfer ◽  
...  

Abstract Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract


2014 ◽  
Vol 6 (6) ◽  
pp. 943-954
Author(s):  
Evgeny Andreevich Ovcharenko ◽  
Kirill Urievitch Klyshnikov ◽  
Gennady Victorovich Savrasov ◽  
Dmitry Vladimirovich Nyshtaev ◽  
Tatiana Vladimirovna Glushkova

2014 ◽  
Vol 30 (9) ◽  
pp. 1109.e3-1109.e4 ◽  
Author(s):  
Christopher Tarola ◽  
Bob Kiaii ◽  
Patrick Teefy ◽  
Pantelis Diamantorous ◽  
Daniel Bainbridge ◽  
...  

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Miriam Silaschi ◽  
Olaf Wendler ◽  
Liesa Castro ◽  
Moritz Seiffert ◽  
Edith Lubos ◽  
...  

Objectives: Transcatheter aortic valve-in-valve implantation (ViV) is an innovative treatment for failed tissue valves (TV) in patients at high surgical risk. However, direct comparative data with standard repeat surgical aortic valve replacement (RE-SAVR) is scarce. We aimed to compare outcomes after ViV to conventional RE-SAVR in two European centers with established interventional programs. Methods: Retrospectively we explored in-hospital databases for patients ≥60 years, treated for degenerated TV. Patients with endocarditis and combined procedures were excluded. Primary endpoints were adjudicated according to VARC-2 criteria. Results: Between 2002 and 2015, 130 patients were treated for isolated failure of aortic TV’s (ViV: n=71, RE-SAVR: n=59). In ViV, Edwards Sapien valve (ESV) was most frequently used (n=36) but implanted into larger TV’s (CoreValve TV size: 22.2±1.3mm vs. ESV TV size: 24.1±2.0mm, p<0.01). Both age and logistic EuroSCORE I were higher in ViV compared to RE-SAVR (78.6±7.5 vs. 72.9±6.5 ys, p<0.01; 25.1±18.9 vs. 16.8±9.4%, p<0.01). Thirty-day mortality was not significantly different with 4.2% (3/71) after ViV vs. 5.1% (3/59) post RE-SAVR (p=1.0). Device success was achieved in 54.9% (n=39) in ViV and all RE-SAVR patients (p<0.01). Perioperative stroke was not observed after ViV and in 2 patients after RE-SAVR (3.4%, p=0.2). Intensive-care stay was longer after RE-SAVR (3.4±2.9d vs. 1.9±1.8d, p<0.01). Following ViV, 22.5% (n=16) of patients had mild aortic regurgitation, vs. 11.3% (n=8; p=0.25) after RE-SAVR. Mean transvalvular pressure gradients at discharge were higher post ViV (19.3±7.3 vs.12.2±5.6mmHg, p<0.01). Rate of permanent pacemaker implantation was lower after ViV (9.9% vs. 27.1%, p<0.01). Survival at 90- and 180-days was 93.8% and 91.8% vs. 94.4% and 94.4% after ViV and RE-SAVR respectively (p=0.87). Conclusion: Despite a higher risk profile, early mortality was not different between the two treatment arms. Although ViV resulted in elevated postoperative transvalvular pressure gradients and therefore a lower rate of device success, mortality after 180-days was similar to RE-SAVR. At present, both techniques serve as complementary approaches and allow individualized patient care.


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