Clinical outcomes of self-expandable vs. balloon-expandable TAVI for severe aortic stenosis

Tham, J.; Adams, Heath; Paleri, S.; Wright, Christine; Dimitriou, Jim; Newcomb, Andrew; MacIsaac, Andrew; Whitbourn, Robert; Palmer, Sonny

doi:10.1080/00015385.2019.1572959

Cited by 3 publications

(3 citation statements)

References 40 publications

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“…It is known that self-expandable valves are inferior regarding the radial force that causes reduced sealing of the PV space and residual leaks, especially in the heavily calcified annulus. 16 In line with previous data, 16,17 we found that PV leak was significantly higher in the self-expandable valve group. Interestingly, we observed higher acquired thrombocytopenia in the self-expandable group than the balloon-expandable group.…”

Section: Discussionsupporting

confidence: 91%

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Evaluation of Acquired Thrombocytopenia According to the Balloon-Expandable Versus Self-Expandable Valves in Patients Undergoing Transcatheter Aortic Valve Replacement

et al. 2020

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In patients with severe aortic stenosis, the data about the incidence of acquired thrombocytopenia according to the use of balloon-expandable or self-expandable valves are limited. We investigated the relationship between the post-transcatheter aortic valve replacement (TAVR) thrombocytopenia and the balloon-expandable or self-expandable valves. A total of 127 consecutive patients who underwent TAVR were retrospectively analyzed. Among the study population, 61 (48%) patients underwent TAVR with the balloon-expandable valve and the 66 (52%) patients with the self-expandable valve. Procedural success did not differ between the groups ( P = .575). The access site complications and in-hospital mortality were the same across the groups ( P = .225 and P = .466). However, paravalvular (PV) leaks were significantly higher in the self-expandable valve group ( P = .007). Among all, 65 patients experienced thrombocytopenia, which was more frequent in the self-expandable valve group (63.6 vs 37.7%, P = .005). In multivariate analyses, admission platelet count, PV leak, and self-expandable valve deployment were the predictors of thrombocytopenia ( P = .001, P = .002, and P = .021, respectively). The present study showed a higher incidence of acquired thrombocytopenia in the self-expandable valve group. Although the procedural success was similar between the groups, postprocedural PV leaks were more common in the self-expandable valve group.

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Section: Discussionsupporting

confidence: 91%

“…Former studies and meta-analysis mainly focused on the difference in procedural aspects of different valve structures. [16][17][18] However, the risk of thrombocytopenia that can be a fatal outcome should be evaluated too while selecting the valve on a patient basis.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Acquired Thrombocytopenia According to the Balloon-Expandable Versus Self-Expandable Valves in Patients Undergoing Transcatheter Aortic Valve Replacement

et al. 2020

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“…Two studies were excluded. In one study (15), the outcome data for Evolut R and Sapien 3 valves were not presented separately. Another study (16) examined gender-based differences in outcomes, in a cohort of Evolut R and Sapien 3 TAVI patients without any comparison between the 2 valves.…”

Section: Resultsmentioning

confidence: 99%

Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

He¹,

Lang

2019

Exp Ther Med

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The aim of this study was to systematically search literature and conduct a meta-analysis comparing the clinical efficacy and safety of Evolut R and Sapien 3 valves for transcatheter aortic valve implantation (TAVI). The PubMed, Biomed Central, Scopus, Cochrane library and Google scholar databases were searched for articles published up to June, 2019. A total of 5 studies were included. In total, 795 patients underwent TAVI with Evolut R, while 665 patients received the Sapien 3 valve in the included studies. Overall device success with Evolut R was 95.7% and with Sapien 3 was 94.2%. Pooled data indicated no significant differences between the 2 valves (OR, 1.12; 95% CI, 0.66–1.89; P=0.68; I2=0%). No significant differences were observed in the incidence of none to mild paravalvular leakage between the 2 groups (OR, 1.71; 95% CI, 0.83–3.54; P=0.14; I2=0%). Both mean [random; mean difference (MD) = −3.96; 95% CI, −4.61 to −3.31; P<0.00001, I2=0%] and peak (random; MD = −6.85; 95% CI, −8.22 to −5.48; P<0.00001, I2=0%) aortic valve gradients were significantly lower with Evolut R. No significant differences were observed in the 30-day mortality (OR, 1.32; 95% CI, 0.45–3.87; P=0.62; I2=0%) or 30-day stroke outcomes (OR, 0.76; 95% CI, 0.32–1.81; P=0.54; I2=0%) between the 2 devices. On the whole, the findings of this study indicate that Evolut R and Sapien 3 valves may be comparable in terms of device success and short-term complications. The differences between the 2 devices for post-operative moderate to severe paravalvular leak and permanent pacemaker implantation remain unclear. There is thus a need for a large multi-center randomized controlled trial to provide stronger evidence on this subject.

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Predictors for the risk of permanent pacemaker implantation after transcatheter aortic valve replacement: A systematic review and meta‐analysis

Wang

Xia

et al. 2021

Journal of Cardiac Surgery

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Background: Transcatheter aortic valve replacement (TAVR) is a less invasive treatment than surgery for severe aortic stenosis. However, its use is restricted by the fact that many patients eventually require permanent pacemaker implantation (PPMI). This meta-analysis was performed to identify predictors of post-TAVR PPMI. Methods:The PubMed, Embase, Web of Science, and Cochrane Library databases were systematically searched. Relevant studies that met the inclusion criteria were included in the pooling analysis after quality assessment. Results:After pooling 67 studies on post-TAVR PPMI risk in 97,294 patients, balloon-expandable valve use was negatively correlated with PPMI risk compared with self-expandable valve (SEV) use (odds ratio [OR]: 0.44, 95% confidence interval [CI]: 0.37-0.53). Meta-regression analysis revealed that history of coronary artery bypass grafting and higher Society of Thoracic Surgeons (STS) risk score increased the risk of PPMI with SEV utilization. Patients with pre-existing cardiac conduction abnormalities in 28 pooled studies also had a higher risk of PPMI (OR: 2.33, 95% CI:1.90-2.86). Right bundle branch block (OR: 5.2, 95% CI: 4.37-6.18) and first-degree atrioventricular block (OR: 1.97, 95% CI: 1.38-2.79) also increased PPMI risk. Although the trans-femoral approach was positively correlated with PPMI risk, the trans-apical pathway showed no statistical difference to the trans-femoral pathway.The approach did not increase PPMI risk in patients with STS scores >8. Patientprosthesis mismatch did not influence post-TAVR PPMI risk (OR: 0.88, 95% CI: 0.67-1.16). We also analyzed implantation depth and found no difference between patients with PPMI after TAVR and those without.Conclusions: SEV selection, pre-existing cardiac conduction abnormality, and transfemoral pathway selection are positively correlated with PPMI after TAVR. Preexisting left bundle branch block, patient-prosthesis mismatch, and implantation depth did not affect the risk of PPMI after TAVR.

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Clinical outcomes of self-expandable vs. balloon-expandable TAVI for severe aortic stenosis

Cited by 3 publications

References 40 publications

Evaluation of Acquired Thrombocytopenia According to the Balloon-Expandable Versus Self-Expandable Valves in Patients Undergoing Transcatheter Aortic Valve Replacement

Evaluation of Acquired Thrombocytopenia According to the Balloon-Expandable Versus Self-Expandable Valves in Patients Undergoing Transcatheter Aortic Valve Replacement

Safety and efficacy of self‑expandable Evolut R vs. balloon‑expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta‑analysis

Predictors for the risk of permanent pacemaker implantation after transcatheter aortic valve replacement: A systematic review and meta‐analysis

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