Reduced Leaflet Motion in Bioprosthetic Aortic Valves — The FDA Perspective

Laschinger, John C.; Wu, Changfu; Ibrahim, Nicole G.; Shuren, Jeffrey

doi:10.1056/nejmp1512264

Cited by 47 publications

(27 citation statements)

References 3 publications

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“…However, maximum follow‐up is currently limited to 5 years with very few patients followed for more than 2 years postoperatively, which prohibits definitive conclusions regarding clinical outcomes. The potential for increased risks of adverse events related to HALT and RLM warrants systematic investigation …”

Section: Discussionmentioning

confidence: 99%

“…The prevalence of RLM and HALT has been studied in a small number of different types of surgically implanted bioprostheses . Additional data for prosthetic heart valves have been requested by the US Food and Drug Administration (FDA) . Patients are frequently asymptomatic and the abnormalities have been detected incidentally.…”

Section: Introductionmentioning

confidence: 99%

“…4 Additional data for prosthetic heart valves have been requested by the US Food and Drug Administration (FDA). 5 Patients are frequently asymptomatic and the abnormalities have been detected incidentally. Leaflet thrombosis has been speculated to be the underlying cause of HALT and RLM because anticoagulation therapy with warfarin has been associated with a decreased prevalence of RLM.…”

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confidence: 99%

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Hypo‐Attenuated Leaflet Thickening and Reduced Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

Dalén

Sartipy

Cederlund

et al. 2017

JAHA

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BackgroundThe prevalence of hypo‐attenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) is unknown in surgically implanted bioprostheses because systematic investigation of HALT and/or RLM is limited to a few catheter‐based valves. The aim of this study was to investigate the prevalence of HALT and RLM by cardiac computed tomography in patients who underwent surgical aortic valve replacement and received a Perceval sutureless aortic valve bioprosthesis.Methods and ResultsThis was a single‐center prospective observational study that included 47 patients (83.5% of the total number of implantations) who underwent surgical aortic valve replacement with implantation of the Perceval sutureless bioprosthesis (LivaNova PLC, London, UK) at Karolinska University Hospital in Stockholm, Sweden from 2012 to 2016 and were studied by cardiac computed tomography. Cardiac computed tomography was performed at a median of 491 days (range 36–1247 days) postoperatively. HALT was found in 18 (38%) patients and RLM in 13 (28%) patients. All patients with RLM had HALT. Among patients with HALT, 5 out of 18 patients (28%) were treated with anticoagulation (warfarin or any novel oral anticoagulant) at the time of cardiac computed tomography. Among patients with RLM, 3 out of 13 patients (23%) were treated with anticoagulation.Conclusions HALT and RLM were prevalent in the surgically implanted Perceval sutureless aortic valve bioprosthesis. Both HALT and RLM were found in patients with ongoing anticoagulation treatment. Whether these findings are associated with adverse events needs further study.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02671474.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Hypo‐Attenuated Leaflet Thickening and Reduced Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

Dalén

Sartipy

Cederlund

et al. 2017

JAHA

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“…[ 1 ] BPVT can be asymptomatic and detected by a routine echocardiography. [ 7 ] On the other hand, BPVT can be life-threatening and may result in severe symptoms, hemodynamic instability, and rapid deterioration. [ 1 ] Commonly used echocardiographic features to help diagnose BPVT are an increase in the mean transvalvular gradient >50% above baseline values within 5 years, thickened leaflets, and restriction in leaflets mobility.…”

Section: Discussionmentioning

confidence: 99%

Human menopausal gonadotropin-induced bioprosthetic valve thrombosis

et al. 2018

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Bioprosthetic valve thrombosis (BPVT) is a rare but potentially life-threatening complication. Human menopausal gonadotropin (hMG) is commonly used for ovulation induction and has been associated with arterial and venous thrombosis. We reported a case of BPVT related to in vitro fertilization in a 39-year-old female, who underwent redo mitral valve replacement. To the best of our knowledge, this is the first case of hMG-induced BPVT in a young female patient.

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“…Particularly, the occurrence of valve thrombosis is associated with reduced leaflet motion and flow stagnation in the sinuses [6][7][8]. These findings trigger concerns regarding an increased risk of stroke and the limitation of long-term valve durability [9]. The mechanisms leading to thrombosis in the cardiovascular system are traditionally described by means of Virchow's triad [10]: hemodynamic factor (fluid stasis and/or high shear stresses), surface factor (endothelial injury, leaflet damage), and hemostatic factor (hypercoagulability, significant tissue injury) [7,11].…”

Section: Introductionmentioning

confidence: 99%

Computational flow analysis of the washout of an aortic valve by means of Eulerian transport equation

Stiehm

Borowski

Kaule

et al. 2019

Current Directions in Biomedical Engineering

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Although the development of the transcatheter aortic valve (TAV) has saved many lives of inoperable patients and has a very good clinical outcome, concerns about valve thrombosis are increasing. Due to the potential risk of late clinically relevant events, the US Food and Drug Administration (FDA) suggests a careful systematic investigation of thrombosis and reduced leaflet motion related to hemodynamic changes induced by TAV implantation. Furthermore, recently published position papers of the ISO working group address numerical and experimental flow field assessment of TAV. In particular, pathologically high shear rates and a reduced washout of the sinuses may increase the risk of valve thrombosis and should therefore be investigated. By means of fluid-structure interaction (FSI) as a powerful in silico tool, the transient flow field in an aortic valve was analyzed. A linear elastic behavior was assumed for leaflet material properties (Young modulus: 10 MPa, Poisson ratio: 0.46 and leaflet material density: 1000 kg/m3) and blood was specified as a homogeneous, Newtonian and incompressible fluid (fluid density: 1060 kg/m3 and a dynamic viscosity: 0.0035 Pa s). In this numerical study we present a Eulerian approach, which is based on transport equation of the residence time (RT) as a passively transported scalar. It can be clearly seen that the RT is significantly higher in the sinus referred to the main flow. At time step t = 0.25 s, the average residence time in the main flow is RTavg ≈ 0.05 s, whereas RT ≈ 0.25 s in the sinus. In particular, RT is a valuable hemodynamic metric to quantify the washout of the sinus in order to evaluate the thrombogenic potential of TAV devices. Further studies will concentrate on particle image velocimetry measurements for validation purposes. In particular the velocity in the sinus and therefore the washout is one important hemodynamic key feature that has to be improved for future TAV designs.

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Reduced Leaflet Motion in Bioprosthetic Aortic Valves — The FDA Perspective

Cited by 47 publications

References 3 publications

Hypo‐Attenuated Leaflet Thickening and Reduced Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

Hypo‐Attenuated Leaflet Thickening and Reduced Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

Human menopausal gonadotropin-induced bioprosthetic valve thrombosis

Computational flow analysis of the washout of an aortic valve by means of Eulerian transport equation

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