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- Cannata, Stefano, et al.
(författare)
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One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloonexpandable valve : the S3U registry
- 2023
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Ingår i: EuroIntervention. - : Europa Digital & Publishing. - 1774-024X .- 1969-6213. ; 18:17, s. 1418-
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Tidskriftsartikel (refereegranskat)abstract
- Background: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce.Aims: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3).Methods: The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year.Results: The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups.Conclusions: Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.
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- Petraco, Ricardo, et al.
(författare)
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Real-time use of instantaneous wave-free ratio: Results of the ADVISE in-practice: An international, multicenter evaluation of instantaneous wave-free ratio in clinical practice
- 2014
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Ingår i: American Heart Journal. - : Elsevier BV. - 1097-6744 .- 0002-8703. ; 168:5, s. 739-748
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Tidskriftsartikel (refereegranskat)abstract
- Objectives To evaluate the first experience of real-time instantaneous wave-free ratio (iFR) measurement by clinicians. Background The iFR is a new vasodilator-free index of coronary stenosis severity, calculated as a trans-lesion pressure ratio during a specific period of baseline diastole, when distal resistance is lowest and stable. Because all previous studies have calculated iFR offline, the feasibility of real-time iFR measurement has never been assessed. Methods Three hundred ninety-two stenoses with angiographically intermediate stenoses were included in this multicenter international analysis. Instantaneous wave free ratio and fractional flow reserve (FFR) were performed in real time on commercially available consoles. The classification agreement of coronary stenoses between iFR and FFR was calculated. Results Instantaneous wave-free ratio and FFR maintain a close level of diagnostic agreement when both are measured by clinicians in real time (for a clinical 0.80 FFR cutoff: area under the receiver operating characteristic curve [ROCAUC] 0.87, classification match 80%, and optimal iFR cutoff 0.90; for a ischemic 0.75 FFR cutoff: iFR ROCAUC 0.90, classification match 88%, and optimal iFR cutoff 0.85; if the FFR 0.75-0.80 gray zone is accounted for: ROCAUC 0.93, classification match 92%). When iFR and FFR are evaluated together in a hybrid decision-making strategy, 61% of the population is spared from vasodilator while maintaining a 94% overall agreement with FFR lesion classification. Conclusion When measured in real time, iFR maintains the close relationship to FFR reported in offline studies. These findings confirm the feasibility and reliability of real-time iFR calculation by clinicians.
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