New Braile Inovare transcatheter aortic prosthesis: clinical results and follow-up

Gaia, Diego Felipe; Breda, João Roberto; Ferreira, Carolina Baeta Neves Duarte; Souza, José Augusto Marcondes de; Macedo, Murilo Teixeira; Gimenes, Marcus Vinícius; Couto, A. Alves De; Simonato, Matheus; Financi, Luis Furlan; Buffolo, Ênio; Palma, José Honório

doi:10.4244/eijv11i6a136

Cited by 18 publications

(16 citation statements)

References 19 publications

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“…Mean transvalvular pressure drops were increased from a range of 3.5-11.0 mmHg to 10.2-18.2 mmHg, respectively. Comparison to clinical data with the Inovare of 14.1 ± 8.0 mmHg from 90 high risk patients [42], confirms that the results in the AS patient case modeled were very realistic and lied in the middle of the clinical range. It should be noted though that while the 24 mm Inovare was the most common device size used in this study, direct comparison to our results could not be performed per equivalent valve size and CO, as this data was not provided.…”

Section: Discussionmentioning

confidence: 54%

Realistic Vascular Replicator for TAVR Procedures

Rotman

Kovarovic

Sadasivan

et al. 2018

Cardiovasc Eng Tech

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Transcatheter aortic valve replacement (TAVR) is an over-the-wire procedure for treatment of severe aortic stenosis (AS). TAVR valves are conventionally tested using simplified left heart simulators (LHS). While those provide baseline performance reliably, their aortic root geometries are far from the anatomical in situ configuration, often overestimating the valves' performance. We report on a novel benchtop patient-specific arterial replicator designed for testing TAVR and training interventional cardiologists in the procedure. The Replicator is an accurate model of the human upper body vasculature for training physicians in percutaneous interventions. It comprises of fully-automated Windkessel mechanism to recreate physiological flow conditions. Calcified aortic valve models were fabricated and incorporated into the Replicator, then tested for performing TAVR procedure by an experienced cardiologist using the Inovare valve. EOA, pressures, and angiograms were monitored pre- and post-TAVR. A St. Jude mechanical valve was tested as a reference that is less affected by the AS anatomy. Results in the Replicator of both valves were compared to the performance in a commercial ISO-compliant LHS. The AS anatomy in the Replicator resulted in a significant decrease of the TAVR valve performance relative to the simplified LHS, with EOA and transvalvular pressures comparable to clinical data. Minor change was seen in the mechanical valve performance. The Replicator showed to be an effective platform for TAVR testing. Unlike a simplified geometric anatomy LHS, it conservatively provides clinically-relevant outcomes and complement it. The Replicator can be most valuable for testing new valves under challenging patient anatomies, physicians training, and procedural planning.

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Section: Discussionmentioning

confidence: 54%

Realistic Vascular Replicator for TAVR Procedures

Rotman

Kovarovic

Sadasivan

et al. 2018

Cardiovasc Eng Tech

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“…Although the transapical technique is more invasive, the advantages over the femoral pathway are: greater ease of valve implantation due to the proximity of the valve annulus of the cardiac apex, less manipulation of the aorta and peripheral arterial system reducing vascular complications and stroke. 1 , 4 There is no impediment to the use of this technique in patients with previous myocardial revascularization.…”

Section: Discussionmentioning

confidence: 99%

Combined Mitral and Aortic Valvar Bioprosthesis Transcatheter Transapical Implant: First Description in Brazil

Sampaio¹,

Paixão²,

Miranda³

et al. 2017

Arquivos Brasileiros De Cardiologia

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“…Surgical procedures were conducted in a hybrid operating room, using fluoroscopic and echocardiographic guidance. The transcatheter valve utilized in all patients was the Braile Inovare ® prosthesis, a balloon expandable valve platform with a chromium-cobalt stent frame, widely used in Brazilian experience [16,17] .…”

Section: Methodsmentioning

confidence: 99%

Thrombocytopenia After Transcatheter Valvein- Valve Implantation: Prognostic Marker or Mere Finding?

Souza¹,

Paim²,

Viotto³

et al. 2018

Braz J Cardiovasc Surg

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ObjectiveTo analyze the behavior of platelets after transcatheter valve-in-valve implantation for the treatment of degenerated bioprosthesis and how they correlate with adverse events upon follow-up.MethodsRetrospective analysis of 28 patients who received a valve-in-valve implant, 5 in aortic, 18 in mitral and 5 in tricuspid positions. Data were compared with 74 patients submitted to conventional redo valvular replacements during the same period, and both groups' platelet curves were analyzed. Statistical analysis was conducted using the IBM SPSS Statistics(r) 20 for Windows.ResultsAll patients in the valve-in-valve group developed thrombocytopenia, 25% presenting mild (<150.000/µL), 54% moderate (<100.000/µL) and 21% severe (<50.000/µL) thrombocytopenia. The platelet nadir was on the 4th postoperative day for aortic ViV, 2nd for mitral and 3rd for tricuspid patients, with the majority of patients recovering regular platelet count. However, the aortic subgroup comparison between valve-in-valve and conventional surgery showed a statistically significant difference from the 7th day onwards, where valve-in-valve patients had more severe and longer lasting thrombocytopenia. This, however, did not translate into a higher postoperative risk. In our study population, postoperative thrombocytopenia did not correlate with greater occurrence of adverse outcomes and only normal preoperative platelet count could significantly predict a postoperative drop >50%.ConclusionAlthough thrombocytopenia is an extremely common finding after valve-in-valve procedures, the degree of platelet count drop did not correlate with greater incidence of postoperative adverse outcomes in our study population.

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New Braile Inovare transcatheter aortic prosthesis: clinical results and follow-up

Cited by 18 publications

References 19 publications

Realistic Vascular Replicator for TAVR Procedures

Realistic Vascular Replicator for TAVR Procedures

Combined Mitral and Aortic Valvar Bioprosthesis Transcatheter Transapical Implant: First Description in Brazil

Thrombocytopenia After Transcatheter Valvein- Valve Implantation: Prognostic Marker or Mere Finding?

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