Mechanical prosthetic heart valves: Quality of anticoagulation and thromboembolic risk. The observational multicenter PLECTRUM study

Poli, Daniela; Antonucci, Emilia; Pengo, Vittorio; Migliaccio, Ludovica; Testa, Sophie; Lodigiani, Corrado; Coffetti, Nadia; Facchinetti, Roberto; Serricchio, Giuseppina; Falco, Pietro; Mangione, Catello; Masottini, Serena; Ruocco, L; Caterina, Raffaele De; Palareti, Gualtiero

doi:10.1016/j.ijcard.2018.04.042

Cited by 43 publications

(41 citation statements)

References 29 publications

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“…Among patients with atrial fibrillation, studies have shown an association between low quality of VKA treatment and the risk of outcomes, whereas studies on patients with mechanical heart valve have shown contradictory results. [8][9][10][11] This nationwide, carefully designed study set out to examine the association between TTR and the risk of thromboembolic events and bleeding in patients with mechanical valve prostheses.…”

Section: Perspectivementioning

confidence: 99%

“…Results: In total, 659 patients undergoing mechanical heart valve replacement were included in the study. Median number of international normalized ratio measurements in the 6-month period after surgery was 13 (interquartile range, [8][9][10][11][12][13][14][15][16][17][18][19]. Median TTR was 54.9% (interquartile range, 39.0%-72.9%) and 29.1% of patients had a TTR !70%.…”

mentioning

confidence: 99%

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Time in therapeutic range and risk of thromboembolism and bleeding in patients with a mechanical heart valve prosthesis

Havers-Borgersen

Butt

Vinding

et al. 2020

The Journal of Thoracic and Cardiovascular Surgery

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Objective: Oral anticoagulation with vitamin K antagonists is recommended after mechanical heart valve replacement. However, data regarding the association between the quality of vitamin K antagonist treatment and the risk of complications are sparse.Methods: Patients undergoing mechanical heart valve replacement (1997)(1998)(1999)(2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)(2010)(2011)(2012) with available data on international normalized ratio values were identified in Danish registries. The quality of vitamin K antagonist treatment between discharge after valve replacement and 6 months postdischarge (ie, index) was assessed as time in therapeutic range (TTR) !70% or<70% reflecting the percentage of time in therapeutic international normalized ratio interval. Patients were followed from index until occurrence of an outcome of interest (ie, thromboembolism and bleeding), death, or end of study (December 31, 2012), whichever came first. The risk of outcomes according to quality of vitamin K antagonist treatment was estimated with multivariable Cox regression.See Commentaries on pages 84 and 86.More than 100 million people worldwide experience valve diseases and the prevalence is expected to increase concurrently with increasing life expectancy. 1 Worldwide, From the

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Section: Perspectivementioning

confidence: 99%

mentioning

confidence: 99%

Time in therapeutic range and risk of thromboembolism and bleeding in patients with a mechanical heart valve prosthesis

Havers-Borgersen

Butt

Vinding

et al. 2020

The Journal of Thoracic and Cardiovascular Surgery

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“…Their implantation is associated with reduced quality of life. Mechanical prostheses require life-long anticoagulation therapy and are associated with a substantially high risk of bleedings [5]. Tissue heart valves are susceptible to calcification and degeneration resulting in the structural failure, requiring repeat surgery [6,7].…”

Section: Introductionmentioning

confidence: 99%

Polyisobutylene-Based Thermoplastic Elastomers for Manufacturing Polymeric Heart Valve Leaflets: In Vitro and In Vivo Results

et al. 2019

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Superior polymers represent a promising alternative to mechanical and biological materials commonly used for manufacturing artificial heart valves. The study is aimed at assessing poly(styrene-block-isobutylene-block-styrene) (SIBS) properties and comparing them with polytetrafluoroethylene (Gore-texTM, a reference sample). Surface topography of both materials was evaluated with scanning electron microscopy and atomic force microscopy. The mechanical properties were measured under uniaxial tension. The water contact angle was estimated to evaluate hydrophilicity/hydrophobicity of the study samples. Materials’ hemocompatibility was evaluated using cell lines (Ea.hy 926), donor blood, and in vivo. SIBS possess a regular surface relief. It is hydrophobic and has lower strength as compared to Gore-texTM (3.51 MPa vs. 13.2/23.8 MPa). SIBS and Gore-texTM have similar hemocompatibility (hemolysis, adhesion, and platelet aggregation). The subcutaneous rat implantation reports that SIBS has a lower tendency towards calcification (0.39 mg/g) compared with Gore-texTM (1.29 mg/g). SIBS is a highly hemocompatible material with a promising potential for manufacturing heart valve leaflets, but its mechanical properties require further improvements. The possible options include the reinforcement with nanofillers and introductions of new chains in its structure.

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“…A recent observational study from Italy provided some reassuring data. 2 In a cohort of more than 2350 patients in the Italian Federation of Anticoagulation Clinics, the overall rate of TE events was only 0.67 per 100 patient years. In contrast, the bleeding risk was slightly higher at 1.0 major bleeds per 100 patient years.…”

Section: Vivek Rao MD Phdmentioning

confidence: 98%

Commentary: Scylla versus Charybdis: The eternal dilemma continues

Rao

2019

The Journal of Thoracic and Cardiovascular Surgery

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Mechanical prosthetic heart valves: Quality of anticoagulation and thromboembolic risk. The observational multicenter PLECTRUM study

Cited by 43 publications

References 29 publications

Time in therapeutic range and risk of thromboembolism and bleeding in patients with a mechanical heart valve prosthesis

Time in therapeutic range and risk of thromboembolism and bleeding in patients with a mechanical heart valve prosthesis

Polyisobutylene-Based Thermoplastic Elastomers for Manufacturing Polymeric Heart Valve Leaflets: In Vitro and In Vivo Results

Commentary: Scylla versus Charybdis: The eternal dilemma continues

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