Clinical outcome and paravalvular leakage of the new balloon‐expandable Edwards Sapien 3 valve in comparison to its predecessor model (Edwards Sapien XT) in patients undergoing transfemoral aortic valve replacement

Bocksch, Wolfgang; Grossmann, Benita; Geisler, Tobias; Steeg, M. van der; Droppa, Michal; Jorbenadze, Rezo; Haap, Michael; Gawaz, Meinrad; Fateh-Moghadam, Suzanne

doi:10.1002/ccd.26562

Cited by 15 publications

(15 citation statements)

References 30 publications

(63 reference statements)

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“…The clinical outcomes for the Su‐AV and current‐generation TAVR devices are similar with respect to rates of para‐valvular leak . Current TAVR studies will present new data not yet available, that will further examine PVL rates in the low risk cohort .…”

Section: Discussionmentioning

confidence: 91%

Permanent pacemaker implantation and paravalvular leak rates following sutureless aortic valve operations

et al. 2018

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Background: Permanent pacemaker (PPM) implantation and paravalvular leak (PVL) rates after sutureless aortic valve replacement (SuAVR) vary widely. The aim of this metaanalysis was to examine the incidence of new PPM implantation and PVL after SuAVR.Methods: Studies evaluating PPM implantation and PVL rates after SuAVR were searched in Medline/PubMed, Ovid Journals, Clinicaltrials.gov, Cochrane central register of controlled trials and database. Studies with a sample size ≥10 were included in this analysis. Pooled proportions were calculated using both the fixed and randomeffects models. The heterogeneity among studies was tested using I 2 statistic. The study design was written in accordance with PRISMA guidelines.Results: Thirty studies involving 3993 patients with a median follow-up of 12 months were included. The median age was 77 years and males constituted 50%. There was a history of stroke and coronary artery disease in 6% and 31% of the population. Pooled proportions demonstrate a cumulative postoperative PPM rate of 8.5% (95% confidence interval [CI] 7.6-9.5%, I 2 = 68.8%) and the overall rate of any PVL was 4.2% (95%CI 3.4-5%, I 2 = 76.1%) across all major SuAVR devices. The rate of severe PVL was only 0.4% (95%CI 0.2-0.7%, I 2 = 0%) at discharge and 0.5% (95%CI 0.2-0.9%, I 2 = 0%) at 12 months. Conclusions:In SuAVR prostheses implanted in this meta-analysis, the postoperative permanent pacemaker rate was higher (8.5%) than reported for non-SuAVR prosthesis.While the overall PVL rate was 4.2%, the incidence of severe PVL was only 0.4% at discharge and remained stable at 0.5% at 12 months. K E Y W O R D S paravalvular leak, permanent pacemaker, rapid deployment aortic valve, sutureless aortic valve

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Section: Discussionmentioning

confidence: 91%

Permanent pacemaker implantation and paravalvular leak rates following sutureless aortic valve operations

et al. 2018

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“…To examine the influence of the route of access on TAVR outcomes, we examined reports of TF‐only TAVR as a separate subgroup. Pooled analysis of five articles showed no difference in pacemaker implantation rates between the two valves (Online Figure ).…”

Section: Resultsmentioning

confidence: 99%

“…Reports mentioning outcomes of S3V or SXT were considered. After applying the eligibility criteria, 15 articles (11 observational studies , 4 conference papers ) were selected for inclusion in our meta‐analysis, representing a pooled total of 4,496 patients (S3V: 1,700, SXT: 2,796) (Figure : PRISMA Flowchart showing selection process for included articles).…”

Section: Resultsmentioning

confidence: 99%

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Clinical and procedural outcomes with the SAPIEN 3 versus the SAPIEN XT prosthetic valves in transcatheter aortic valve replacement: A systematic review and meta‐analysis

Tummala

Banerjee

Sankaramangalam

et al. 2017

Cathet Cardio Intervent

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“…As expected, the number of any kind of PVL was reduced with the S3 THV, and the rate of moderate or severe PVL has decreased from 6.9% with SAPIEN XT to 1.6% with S3. 21 – 25 Besides technical developments of the valve design, more sophisticated sizing algorithms with a routine use of pre-procedural MSCT may also have contributed to a reduction in PVL by an optimized valve deployment. 8 …”

Section: Sapien 3 Transcatheter Heart Valvementioning

confidence: 99%

Spotlight on the SAPIEN 3 transcatheter heart valve

Rheude¹,

Blumenstein²,

Möllmann³

et al. 2018

MDER

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Transcatheter aortic valve implantation (TAVI) is increasingly performed in patients with severe aortic stenosis. The efficacy and safety have been demonstrated in large randomized trials in patients with high- or intermediate operative risk. With latest-generation transcatheter heart valve (THV) systems, growing operator experience and improved patient selection, clinical outcome has significantly improved with a decline of TAVI-related complications. In this review, the Edwards SAPIEN 3 THV is discussed in terms of technology, procedural advances and complication trends and future developments.

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Clinical outcome and paravalvular leakage of the new balloon‐expandable Edwards Sapien 3 valve in comparison to its predecessor model (Edwards Sapien XT) in patients undergoing transfemoral aortic valve replacement

Abstract: Although there was no significant difference in 30 day mortality, the newer ES3 valve reduced significantly residual paravalvular leakage. © 2016 Wiley Periodicals, Inc.

Cited by 15 publications

References 30 publications

Permanent pacemaker implantation and paravalvular leak rates following sutureless aortic valve operations

Permanent pacemaker implantation and paravalvular leak rates following sutureless aortic valve operations

Clinical and procedural outcomes with the SAPIEN 3 versus the SAPIEN XT prosthetic valves in transcatheter aortic valve replacement: A systematic review and meta‐analysis

Spotlight on the SAPIEN 3 transcatheter heart valve

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