Performance and short-term outcomes of three different transcatheter aortic valve replacement devices in patients with aortic stenosis

Tzeng, Yun Hsuan; Lee, Yung Tsai; Tsao, Tien Ping; Lee, Kuo Chen; Huang, Kuo‐How; Hsiung, Ming C.; Wei, Jeng; Yin, Wei Hsian

doi:10.1097/jcma.0000000000000187

Cited by 2 publications

(11 citation statements)

References 21 publications

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“…According to the current study, only five patients (16.6%) experienced minor bleeding, three patients (10%) experienced major bleeding, and no life-threatening bleeding occurred. This was similar to the results recorded by Yun, et al [24] found the major or life-threatening bleeding among (Medtronic Core valve was 2%, and SAPIEN XT was 5%), at 30 days post TAVI [24].…”

Section: Discussionsupporting

confidence: 90%

“…The first Egyptian experience with TAVI was conducted on ten participants using the Edward's Sapien valve and demonstrated a 100% success rate [26]. (Yun, et al 2019) reported the device success rate was 90% for SXT, 83% for Lotus, and 86% for MCV (p=NS) [24]. Our study reported no mortality was reported during the procedure in comparison to other studies.…”

Section: Discussionmentioning

confidence: 44%

“…This is similar to what has been recorded in other studies. Yun, et al [24] found the (9%) patients with Medtronic core valve and (4%) patients with SAPIEN XT required implantation of a second valve due to initial implant embolization to the ascending aorta or mispositioning [24]. According to the CHOICE study, second valve implantation (transcatheter valve-in-valve) was also more common in the self-expandable group (5.8%) than in the balloon-expandable group (0.8%) (P=.03) [33].…”

Section: Discussionmentioning

confidence: 99%

“…No serious aortic resurge was reported. (Yun et al, 2019) reported the incidence of moderate/severe AR at 30 days with Medtronic core valve and SAPIEN XT valve was (7% and 3%) respectively [24]. Hagar et al, [12] reported the incidence of ≥mild PVL was (29.3%) after the procedure.…”

Section: Discussionmentioning

confidence: 99%

“…Our findings are consistent with the CHOICE trial regarding paravalvular aortic regurgitation rate in grades 0 and 1 but were inconsistent with those of the CHOICE trial regarding grades 3 and 4. Yun, et al [24] reported that moderate or more severe PVR after TAVR occurred in (4%) in the Medtronic Core Valve subgroup with MCV and in (2%) in the Sapien valve subgroup [24].…”

Section: Discussionmentioning

confidence: 99%

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Incidence, Outcomes and Predictors of Aortic Regurgitation After Transcatheter Aortic Valve Replacement in Al Azhar University Hospitals and National Heart Institute, Egypt

Elmaksoud¹

2022

J Cardiol Cardiovasc Res

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Background: Aortic regurgitation (AR), which has ill-defined predictors and an unknown long-term influence on outcomes, is a significant transcatheter aortic valve replacement (TAVR) constraint. Objective: this research aimed to assess the prevalence, identify predictors, and evaluate the outcomes of aortic regurgitation following trans catheter aortic valve implantation (TAVI). 1. To calculate the prevalence of aortic regurgitation in elderly patients receiving trans catheter aortic valve implantation who have severe symptomatic aortic stenosis. 2. To determine aortic regurgitation risk factors after trans catheter aortic valve implantation. Methods: From November 2017 to November 2020, this prospective observational study was done in the National Heart Institute on severe aortic valve stenosis patients above 65 years who were candidates for aortic valve replacement from the outpatient department. Results: LVEF significantly improved. Compared to before TAVI (55.08 ± 9.71), LVEF elevated to 58.9 ± 8.8 (P<0.001). Twenty-five patients (83.3%) showed class III/IV, four patients (13.3%) showed class II, and one patient (3.3%) showed class I before TAVI. While after TAVI, three patients (10%) only showed NYHA class III/IV, six patients (20 %) in class II, and 21 patients (70%) improved to be in class I. The left ventricular mass index mean was 158 ±32.37 before TAVI and 133.50 ±21.96 after TAVI (p<0.001). Compared to before TAVI (0.75 ± 0.2), mean aortic valve area was improved to 2.0 ± 0.2 following TAVI (P<0.001). A significant reduction in the mean pressure gradient from 47 ± 11.08 mmHg across the native valve prior to TAVI to 10.28 ± 3.21 mmHg across the prosthetic valve following TAVI (P <0.001). Expert commentary: The clinical and results of TAVR devices were clearly outlined in literature study. The study showed a high incidence of pacemaker implantation with Core valve and aortic regurgitation. This information strongly supports the need for a randomized trial with sufficient power to compare the most recent self-expandable valve generation to balloon expandable valves. In the 2019 PARTNER 3 prospective randomized trial, it was discovered that, when compared to surgical management, low-risk patients (defined as STS 4%) had a lower risk of the composite outcome of stroke, death, and rehospitalization at 1 year. Additionally, it was shown that TAVR had a lower risk of stroke and required less time in the hospital (3 days as opposed to 7, P0.001) than surgery [1]. In addition, despite an elevated permanent pacemaker implantation rate, the 2019 Medtronic Evolut Transcatheter Aortic Valve Replacement revealed no inferiority for composite all-cause stroke and death, as well as a statistically significant decrease in the rates of life-threatening bleeding, acute kidney injury and atrial fibrillation, compared with SAVR at 30 days following the procedure [2]. Conclusion: According to the study in high-risk patients with severe symptomatic aortic stenosis, TAVI is alternative, viable, safe, and successful therapy compared to traditional open-heart surgery.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 44%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Incidence, Outcomes and Predictors of Aortic Regurgitation After Transcatheter Aortic Valve Replacement in Al Azhar University Hospitals and National Heart Institute, Egypt

Elmaksoud¹

2022

J Cardiol Cardiovasc Res

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Short- and Long-term Clinical Outcomes of Balloon-expandable Versus Self-expanding Valves in Patients Undergoing Transcatheter Aortic Valve Replacement: A Meta-analysis

Wong,

Gan,

Gao

et al. 2023

J Asian Pac Soc Cardiol

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Background: Distinct clinical differences exist between balloon-expandable valves (BEVs) and self-expanding valves (SEVs) used in transcatheter aortic valve replacement (TAVR) for aortic stenosis. However, randomised data on comparative outcomes are limited. The aim of this meta-analysis was to analyse the differences in short- and longer-term clinical outcomes between the two valve designs. Methods: A comprehensive literature search for all studies up to and including April 2020 on the clinical outcomes of BEVs versus SEVs was performed. Study outcomes were divided into short term (in-hospital or 30 days), intermediate term (1 year) and long term (3 years). The primary outcome was all-cause mortality. Secondary endpoints were stroke or transient ischaemic attack (TIA), life-threatening or major bleeding, at least moderate paravalvular leak (PVL), permanent pacemaker (PPM) implantation, aortic valve area (AVA) and aortic valve mean pressure gradient (AV MPG). Results: A total of 41 studies (BEV, n=23,892; SEV, n=22,055) were included. At in-hospital/30 days, all-cause mortality favoured BEV (OR 0.85; 95% CI [0.75–0.96]). BEV had lower rates of PVL (OR 0.42; 95% CI [0.35–0.51]) and PPM (OR 0.56; 95% CI [0.44–0.72]), but smaller AVA (mean −0.09 cm2; 95% CI [−0.17, 0.00]) and higher AV MPG (mean 2.54 mmHg; 95% CI [1.84–3.23]). There were no significant differences in the incidence of stroke/TIA or bleeding between the two valve designs. At 1 year a lower PPM implantation rate (OR 0.44; 95% CI [0.37–0.52]), fewer PVLs (OR 0.26; 95% CI [0.09–0.77]), smaller AVA (mean −0.23 cm2; 95% CI [−0.35, −0.10]) and higher AV MPG (mean 6.05 mmHg; 95% CI [1.74–10.36]) were observed with BEV. No significant differences were observed in mortality, stroke/TIA or bleeding. There was no significant difference in mortality at 3 years between the two valve designs. Conclusion: In the short–intermediate term, SEVs had better valve haemodynamics but had higher PVL and PPM implantation rates than BEVs. However, there were no differences in intermediate–long-term mortality, stroke or TIA, or bleeding complications. A better understanding of these differences will enable TAVR operators to tailor their valve choice based on individual patient profile.

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Performance and short-term outcomes of three different transcatheter aortic valve replacement devices in patients with aortic stenosis

Cited by 2 publications

References 21 publications

Incidence, Outcomes and Predictors of Aortic Regurgitation After Transcatheter Aortic Valve Replacement in Al Azhar University Hospitals and National Heart Institute, Egypt

Incidence, Outcomes and Predictors of Aortic Regurgitation After Transcatheter Aortic Valve Replacement in Al Azhar University Hospitals and National Heart Institute, Egypt

Short- and Long-term Clinical Outcomes of Balloon-expandable Versus Self-expanding Valves in Patients Undergoing Transcatheter Aortic Valve Replacement: A Meta-analysis

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