Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration

Vlastra, Wieneke; Chandrasekhar, Jaya; Muñoz-García, Antonio J.; Tchétché, Didier; Brito, Fábio Sândoli de; Barbanti, Marco; Kornowski, Ran; Latib, Azeem; D’Onofrio, Augusto; Ribichini, Flavio; Baan, Jan; Tijssen, Jan G.P.; Trillo-Nouche, Ramiro; Dumonteil, Nicolas; Abizaid, Alexandre; Sartori, Samantha; D’Errigo, Paola; Tarantini, Giuseppe; Lunardi, Mattia; Orvin, Katia; Pagnesi, Matteo; Valle, Raquel del; Modine, Thomas; Dangas, George; Mehran, Roxana; Piek, Jan J.; Delewi, Ronak

doi:10.1093/eurheartj/ehy805

Cited by 112 publications

(90 citation statements)

References 25 publications

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“…These findings confirm the recent observation by the CENTER(Cerebrovacular-EvenNts-in-Patients-Undergoing-TranscathetER-aortic-valve-implatation)-collaboration initiative of a higher in-hospital mortality with SE-THV compared to BE-THV 13 . However, in that study in which the latest follow-up was at 30 days, the mortality difference was no longer present at that time (p=0.10), and the authors concluded that "there was no difference in 30-day mortality rates between both valve types".…”

Section: Thv-design and Mortalitysupporting

confidence: 90%

“…Recently, a large-scale registry suggested higher in-hospital mortality with the use of SE as compared to BE-THV 13 . Whether this difference persists over time is unclear as the excess mortality was no longer statistically significant by 30 days and as no long-term follow-up was conducted 13 . In addition, no information on PVR was available and no clear explanation was provided to elucidate the association observed in that study.…”

Section: Thvmentioning

confidence: 99%

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Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement

Belle¹,

Vincent²,

Labreuche³

et al. 2020

Circulation

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137

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Background: No randomized study powered to compare balloon-expandable (BE) with self-expanding (SE) transcatheter heart valve (THV) on individual endpoints after transcatheter aortic valve replacement (TAVR) has been conducted to date. Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry included 12,141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for native aortic stenosis (AS). Long-term mortality status was available in all patients (median 20 months, IQR:14-30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity-score (25 clinical, anatomical and procedural variables) and by date of the procedure (within 3 months). The first co-primary outcome was the occurrence of paravalvular regurgitation (PVR)≥moderate and/or in-hospital mortality. The 2 nd co-primary outcome was 2-year all-cause mortality. Results: In matched-propensity analyses, the incidence of the 1st co-primary outcome was higher with SE-THV (19.8%) compared with BE-THV(11.9%; RR=1.68; 95%CI:1.46-1.91; p<0.0001). Each component of the outcome was also higher in SE-THV patients: PVR≥moderate (15.5% vs. 8.3%; RR=1.90; 95% CI:1.63-2.22; p<0.0001) and in-hospital mortality (5.6% vs 4.2%, RR=1.34; 95%CI:1.07-1.66; p=0.01). During follow-up, all-cause mortality occurred in 899 patients treated with SE-THV (2-year mortality was 29.8%) and in 801 patients treated with BE-THV (2-year mortality 26.6%; HR=1.17; 95% CI:1.06-1.29; p=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. Conclusions: The present study suggests that use of SE-THV was associated with a higher risk of PVR and higher in-hospital and 2-year mortality as compared with BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare head-to-head the latest generation of SE and BE-THV.

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Section: Thv-design and Mortalitysupporting

confidence: 90%

Section: Thvmentioning

confidence: 99%

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement

Belle¹,

Vincent²,

Labreuche³

et al. 2020

Circulation

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137

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“…Subsequently, a higher calcification burden may be associated with a higher volume of new white matter hyperintensities after TAVI. Similarly, the current study included only balloon-expandable valves, even though self-expandable valves have been associated with a higher stroke rate [21]. Balloon-expandable valves are implanted rather rapidly, in contrast, self-expandable valves are implanted stepwise and slowly and allow repositioning before the final implantation.…”

Section: Discussionmentioning

confidence: 99%

Aortic valve calcification volumes and chronic brain infarctions in patients undergoing transcatheter aortic valve implantation

Vlastra

Boogert

Krommenhoek

et al. 2019

Int J Cardiovasc Imaging

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Chronic silent brain infarctions, detected as new white matter hyperintensities on magnetic resonance imaging (MRI) following transcatheter aortic valve implantation (TAVI), are associated with long-term cognitive deterioration. This is the first study to investigate to which extent the calcification volume of the native aortic valve (AV) measured with cardiac computed tomography angiography (CTA) predicts the increase in chronic white matter hyperintensity volume after TAVI. A total of 36 patients (79 ± 5 years, median EuroSCORE II 1.9%, Q1–Q3 1.5–3.4%) with severe AV stenosis underwent fluid attenuation inversion recovery (FLAIR) MRI < 24 h prior to TAVI and at 3 months follow-up for assessment of cerebral white matter hyperintensity volume (mL). Calcification volumes (mm3) of the AV, aortic arch, landing zone and left ventricle were measured on the CTA pre-TAVI. The largest calcification volumes were found in the AV (median 692 mm3) and aortic arch (median 633 mm3), with a large variation between patients (Q1–Q3 482–1297 mm3 and 213–1727 mm3, respectively). The white matter hyperintensity volume increased in 72% of the patients. In these patients the median volume increase was of 1.1 mL (Q1–Q3 0.3–4.6 mL), corresponding with a 27% increase from baseline (Q1–Q3 7–104%). The calcification volume in the AV predicted the increase of white matter hyperintensity volume (Δ%), with a 35% increase of white matter hyperintensity volume, per 100 mm3 of AV calcification volume (SE 8.5, p < 0.001). The calcification volumes in the aortic arch, landing zone and left ventricle were not associated with the increase in white matter hyperintensity volume. In 72% of the patients new chronic white matter hyperintensities developed 3 months after TAVI, with a median increase of 27%. A higher calcification volume in the AV was associated with a larger increase in the white matter hyperintensity volume. These findings show the potential for automated AV calcium screening as an imaging biomarker to predict chronic silent brain infarctions.Electronic supplementary materialThe online version of this article (10.1007/s10554-019-01663-0) contains supplementary material, which is available to authorized users.

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“…To date, few comparative studies have been reported on TAVI devices. In particular, Vlaastra and colleagues showed that Sapien3 may be associated with lower surgical conversion rates, fewer strokes and permanent pacemaker implantations (PPI), but more bleedings than Evolut 6 , whereas Pagnesi et al . have reported similar short-term results with Acurate and Evolut 4 .…”

Section: Introductionmentioning

confidence: 99%

Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation

Giordano

Corcione

Ferraro³

et al. 2019

Sci Rep

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Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management.

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Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration

Cited by 112 publications

References 25 publications

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement

Aortic valve calcification volumes and chronic brain infarctions in patients undergoing transcatheter aortic valve implantation

Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation

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