Myval versus alternative balloon- and self-expandable transcatheter heart valves: A central core lab analysis of conduction disturbances.

Santos‐Martínez, Sandra; Halim, Jonathan; Castro-Mejía, Alex F.; Marco, Federico De; Trani, Carlo; Martín, Pedro; Infusino, Fabio; Ancona, Marco; Moreno, Raúl; Heijer, Peter den; Nombela‐Franco, Luis; Bedogni, Francesco; Sardella, Gennaro; Montorfano, Matteo; Revilla‐Orodea, Ana; Delgado-Arana, Jose Raúl; Barrero, Alejandro; Gómez-Salvador, Itziar; Ijsselmuiden, Alexander; Redondo, Alfredo; Gutiérrez, Hipólito; Serrador, Ana; Serruys, Patrick W.; Román, José Alberto San; Amat‐Santos, Ignacio J.

doi:10.1016/j.ijcard.2021.12.049

Cited by 23 publications

(11 citation statements)

References 35 publications

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“…3,18 Several TAVI devices are currently available, including balloon-expandable ones such as Sapien (Edwards Lifesciences), and Myval (Meril Life Sciences), and self-expandable ones such as Evolut (Medtronic), Acurate and Lotus (Boston Scientific), Portico and Navitor (Abbott Laboratories), and Allegra (NVT). 19 Clearly, the multiplicity of designs and devices puts\clear emphasis on patient selection and operator skill, but new-generation devices are clearly associated with more favorable results than earlygeneration ones. 13 Notably, Portico has been recently introduced with favorable procedural and clinical results, despite some issues with valve functionality (given the anedoctal reports of subclinical leaflet thrombosis).…”

Section: Discussionmentioning

confidence: 99%

“…13 Notably, Portico has been recently introduced with favorable procedural and clinical results, despite some issues with valve functionality (given the anedoctal reports of subclinical leaflet thrombosis). 19 Subsequent reports were however more favorable, and further improvements in this TAVI device were provided by a dedicated delivery system, FlexNav. 5,8 Most recently, a new device from the same manufacturer has complemented Portico: Navitor.…”

Section: Discussionmentioning

confidence: 99%

“…Conversely, the role of TAVI is expanding thanks to improvements in access to devices, technological improvements, and procedural refinements 3,18 . Several TAVI devices are currently available, including balloon‐expandable ones such as Sapien (Edwards Lifesciences), and Myval (Meril Life Sciences), and self‐expandable ones such as Evolut (Medtronic), Acurate and Lotus (Boston Scientific), Portico and Navitor (Abbott Laboratories), and Allegra (NVT) 19 . Clearly, the multiplicity of designs and devices puts\clear emphasis on patient selection and operator skill, but new‐generation devices are clearly associated with more favorable results than early‐generation ones 13 …”

Section: Discussionmentioning

confidence: 99%

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Transcatheter aortic valve implantation with the novel‐generation Navitor device: Procedural and early outcomes

Corcione

Berni

Ferraro

et al. 2022

Cathet Cardio Intervent

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Transcatheter aortic valve implantation (TAVI) has proved beneficial in patients with severe aortic stenosis, especially when second‐generation devices are used. We aimed at reporting our experience with Navitor, a third‐generation device characterized by intrannular, large cell, and cuffed design, as well as high deliverability and minimization of paravalvular leak. Between June and December 2021, a total of 39 patients underwent TAVI with Navitor, representing 20% of all TAVI cases. Mean age was 80.0 ± 6.7 years, and 14 (36.8%) women were included. Severe aortic stenosis was the most common indication to TAVI (37 [97.4%] cases), whereas 2 (5.3%) individuals were at low surgical risk. Device and procedural success was obtained in all patients, with a total hospital stay of 6.6 ± 4.5 days. One (2.9%) patient required permanent pacemaker implantation, but no other hospital events occurred. At 1‐month follow‐up, a cardiac death was adjudicated in an 87‐year‐old man who had been at high surgical risk. Echocardiographic follow‐up showed no case of moderate or severe aortic regurgitation, with mild regurgitation in 18 (47%), and none or trace regurgitation in 20 (53%). The Navitor device, thanks to its unique features, is a very promising technology suitable to further expand indications and risk‐benefit profile of TAVI.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Transcatheter aortic valve implantation with the novel‐generation Navitor device: Procedural and early outcomes

Corcione

Berni

Ferraro

et al. 2022

Cathet Cardio Intervent

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“…The MyVal-1 study, the first-in-human prospective study, confirmed the safety and efficacy of the Myval BE valve [16]. From then on, a growing interest in the Myval BE valve can be observed with clinical data gradually expanding and two large-scale randomised controlled trials currently enrolling [17][18][19][20][21][22][23].…”

Section: Original Articlementioning

confidence: 94%

Short-term outcome after transcatheter aortic valve replacement with a novel balloon-expandable valve

et al. 2022

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Objectives Transcatheter aortic valve replacement (TAVR) has been expanding rapidly with numerous transcatheter heart valve (THV) systems currently available. The Myval balloon-expandable (BE) valve (Meril Life Sciences Pvt. Ltd., India) is a novel THV system indicated for the treatment of patients with severe aortic stenosis. The primary objective of this study is to assess the safety and performance of the Myval BE valve. Methods In this prospective single-centre study, 120 consecutive patients who underwent TAVR with the Myval BE valve were included. Clinical outcomes were evaluated at 30 days and 6 months using Valve Academic Research Consortium‑2 criteria. All-cause mortality, stroke, acute kidney injury, major vascular complications, moderate or severe paravalvular leakage (PVL) and need for a permanent pacemaker implantation (PPI) were investigated. Results At 6‑month follow-up, all-cause death and cardiac death were seen in 5.8% and 0.8% of the patients respectively. Periprocedural stroke and need for PPI were both seen in 3.3% of the patients. Access-site-related vascular and bleeding complications were absent. Improved valve haemodynamics and no moderate to severe PVL could be seen at 30 days. An intermediate valve size was selected in 51% of the patients. Conclusions The Myval BE valve demonstrates improved valve haemodynamics, absence of moderate to severe PVL and good safety outcomes at 6‑month follow-up with low cardiac death rate and acceptable rates of permanent pacemaker implantation and periprocedural stroke. Future randomised controlled trials will further establish the clinical utility of the Myval BE valve.

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“…The BEVs appear to have a lower permanent pacing rate with a risk for the new-generation Edwards Lifesciences SAPIEN 3 device ranging between 2.4% and 24% [100]. Similarly, the novel Myval BEV is associated with a low rate of early conduction disturbances [101]. This advantage of BEVs over SEVs in post-TAVI PPI, seems to be maintained even with the last-generation SEVs in lower-risk patients [102,103].…”

Section: Patients At High Risk For Conduction Abnormalitiesmentioning

confidence: 95%

Personalised Treatment in Aortic Stenosis: A Patient-Tailored Transcatheter Aortic Valve Implantation Approach

Mitsis

Yuan

Eftychiou

et al. 2022

JCDD

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Transcatheter aortic valve replacement (TAVI) has become a game changer in the management of severe aortic stenosis shifting the concept from inoperable or high-risk patients to intermediate or low surgical-risk individuals. Among devices available nowadays, there is no clear evidence that one device is better than the other or that one device is suitable for all patients. The selection of the optimal TAVI valve for every patient represents a challenging process for clinicians, given a large number of currently available devices. Consequently, understanding the advantages and disadvantages of each valve and personalising the valve selection based on patient-specific clinical and anatomical characteristics is paramount. This review article aims to both analyse the available devices in the presence of specific clinical and anatomic features and offer guidance to select the most suitable valve for a given patient.

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Myval versus alternative balloon- and self-expandable transcatheter heart valves: A central core lab analysis of conduction disturbances.

Cited by 23 publications

References 35 publications

Transcatheter aortic valve implantation with the novel‐generation Navitor device: Procedural and early outcomes

Transcatheter aortic valve implantation with the novel‐generation Navitor device: Procedural and early outcomes

Short-term outcome after transcatheter aortic valve replacement with a novel balloon-expandable valve

Personalised Treatment in Aortic Stenosis: A Patient-Tailored Transcatheter Aortic Valve Implantation Approach

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