Rivaroxaban in patients undergoing surgical mitral valve repair

Noohi, Feridoun; Sadeghipour, Parham; Kordrostami, Sirous; Shafe, Omid; Maleki, Majid; Kyavar, Majid; Bakhshandeh, Hooman; Rezaei, Yousef; Rokni, Mehrad; Moosavi, Jamal; Amin, Ahmad; Beheshti, Ahmad Tashakori; Hosseini, Saeid

doi:10.1007/s11239-020-02046-2

Cited by 10 publications

(7 citation statements)

References 12 publications

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“…With regard to a low incidence of AF between 14% and 17% and focusing on mitral valve repair, this study would have biased the present meta-analyses but points toward the potential use of DOAC after valve surgery. 28 Two studies investigating the use of DOAC after surgical valve replacement with biological prostheses irrespective of atrial fibrillation, with AF rates between 35% and 39% 29 and between 45% and 65%, 30 reported on comparable thromboembolism rates to VKA of 2.4% 30 and 3.8%. 29 Findings for major bleeding events differed with 0% 29 and 7.1%, 30 but both did not reach statistically significant differences in comparison with VKA.…”

Section: Discussionmentioning

confidence: 99%

Direct oral anticoagulation in atrial fibrillation and heart valve surgery—a meta-analysis and systematic review

Gerfer

Djordjevic

Eghbalzadeh

et al. 2022

Therapeutic Advances in Cardiovascular Disease

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Aims: Oral anticoagulation with direct oral anticoagulants (DOAC) could provide an alternative to vitamin K antagonists (VKA) for patients with atrial fibrillation (AF) undergoing bioprosthetic heart valve replacement or valve repair. Methods and results: The aim of this meta-analysis was to review the safety and efficacy of DOAC in patients with surgical implanted bioprosthetic heart valves or valve repairs and AF including data from six clinical trials with a total of 1,857 patients. The efficacy and safety data of DOAC and VKA were pooled to perform random-effects meta-analyses using the Mantel–Haenszel method with pooled risk ratios (RR) and 95% confidence interval (CI). A trial sequential analysis (TSA) was performed to assess statistical robustness. Death caused by cardiovascular cause or thromboembolic events were comparable (RR 0.67, 95% CI: 0.42–1.08; p = 0.10) as DOAC significantly reduced the risk for major bleeding (RR 0.55, 95% CI: 0.35–0.88; p = 0.01) and thromboembolic stroke or systemic embolism rates (RR 0.54, 95% CI: 0.32–0.90; p = 0.02). Rates for intracranial bleeding and hemorrhagic stroke (RR 0.27, 95% CI: 0.07–0.99; p = 0.05) show a trend toward fewer events in the DOAC group. Outcomes for major or minor bleeding events and all-cause mortality were comparable for DOAC and VKA. Conclusion: Cumulative data analysis reveals that DOAC may provide an effective and safe alternative to VKA in patients with AF after surgically implanted bioprosthetic heart valves or repair with AF. Within a relatively heterogeneous study population, this meta-analysis shows a risk reduction of major bleedings and thromboembolic stroke or systemic embolisms for DOAC.

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Section: Discussionmentioning

confidence: 99%

Direct oral anticoagulation in atrial fibrillation and heart valve surgery—a meta-analysis and systematic review

Gerfer

Djordjevic

Eghbalzadeh

et al. 2022

Therapeutic Advances in Cardiovascular Disease

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“…Two studies (17,19) comparing VKA to antiplatelet treatment had low risk of bias, one (15) had serious risks of bias and one (20) had critical risk of bias in the confounding domain. There were no events in either arm in the only VKA vs DOAC study (16) and zero cell corrections made no difference to the effect estimates. Within the VKA vs no treatment subgroup, one study had critical risk of bias in the selection domain due to exclusion of patients suffering stroke within seven days of discharge (18).…”

Section: Resultsmentioning

confidence: 97%

“…Five studies (16-20) with a total of 5106 patients reported on major bleeding complications following mitral valve repair, comparing post-operative treatment in 2813 patients with VKA anticoagulation against 752 with antiplatelets, 104 with DOAC and 1437 with no treatment. Two studies (19-20) reported on early major bleeding and four (16-18,20) on late bleeding. Two studies in the antiplatelet subgroup were at low risk of bias and one (20) had one domain at critical risk of bias.…”

Section: Resultsmentioning

confidence: 99%

Thromboembolic events and major bleeding with warfarin, non-vitamin K antagonist oral anticoagulants or antiplatelets following mitral valve repair: A systematic review and meta-analysis

Kirmani

Jones

Muir

et al. 2022

Preprint

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Background International guidelines recommend the use of a vitamin K antagonist (VKA, e.g. warfarin) for the first three months after mitral repair as a Class IIa recommendation with Level of Evidence C. High rates of atrial fibrillation, thrombogenicity of the non-endothelialised repair components, and high rates of antiplatelet resistance are cited as rationale. However, surveys of practice indicate that surgeon compliance is low, suggesting uncertainty of the evidence. We sought to establish the best current evidence by conducting a systematic review as a precursor to a randomised trial. Methods We included prospective randomised and retrospective observational studies of adult patients undergoing mitral valve repair with no other indications for anticoagulation. Studies had to compare a VKA to a non-vitamin K antagonist oral anticoagulants (NOAC), anti-platelet or placebo/null treatment ("Other"). Outcomes had to include thromboembolic complications, major bleeding or mortality within three months. The Cochrane Register, Medline, Embase and Clinical Trials Registries were checked. Risk of Bias assessments were conducted using the ROBINS-I tool as part of the GRADE Pro methodology. Quantitative synthesis was agreed following review of the methodology and a random effects model using the Mantel-Haenszel method employed. Results There were no randomised controlled trials comparing VKA to other treatment strategies. Six observational studies comprising 5291 patients (2925 receiving VKA, 807 antiplatelet, 104 NOAC and 1455 null treatment) were included. Four studies reporting early thromboembolic risk found that the use of a VKA may not be associated with a reduction in risk (relative risk [RR] 0.54, 95% CI 0.13 - 2.35, p=0.41, I2 = 68%, overall certainty of evidence = very low). Three studies reporting late thromboembolism also showed that use of VKA may not be associated with risk reduction (RR 0.84, 95% CI 0.57 - 1.24, p=0.37, I2 = 23%). Two studies reported on early risks of major bleeding and found VKA treatment had very uncertain effects (RR 0.60, 95% CI 0.36 - 1.02, p=0.06, I2=0%, certainty of evidence = very low). Late bleeding reported by four studies was uncertain but seemed to show no risk reduction with VKA (RR 0.97, 95% CI 0.37 - 2.52, p=0.95, I2=73%). Three studies found an unclear effect of VKA use on early mortality (RR 0.39, 95% CI 0.10 - 1.51, p=0.17, I2=35%, certainty of evidence = low). Two studies comparing VKA with antiplatelets and no thromboprophylaxis respectively, showed there may be risk reduction in late mortality (RR 0.72, 95% CI 0.59 - 0.87, p=0.0006, I2=0%, certainty of evidence = very low), although this effect was weighted by a single study. Conclusion There is insufficient good quality evidence to inform anticoagulation, anti-platelet or null treatment practices following mitral valve repair. A high-quality trial is therefore required in this setting, with particular methodological focus on aspects found to increase risk of bias in current studies.

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“…Verstraete et al in 2021 provided a useful review with a variety of considerations for antithrombotic treatment after surgery and transcutaneous procedures [ 41 , 42 ]. The use of direct oral anticoagulants (DOACs) is the subject of ongoing studies, although occasional studies have shown MIMVS to have promising results [ 43 ]. Pain relief is essential for enjoying the benefits of minimal access, and interventions under regional and local anesthesia can be considered [ 44 , 45 ].…”

Section: Resultsmentioning

confidence: 99%

At the Crossroads of Minimally Invasive Mitral Valve Surgery—Benching Single Hospital Experience to a National Registry: A Plea for Risk Management Technology

Cocchieri

Wetering

Tuijl

et al. 2022

JCDD

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Almost 30 years after the first endoscopic mitral valve repair, Minimally Invasive Mitral Valve Surgery (MIMVS) has become the standard at many institutions due to optimal clinical results and fast recovery. The question that arises is can already good results be further improved by an Institutional Risk Management Performance (IRMP) system in decreasing risks in minimally invasive mitral valve surgery (MIMVS)? As of yet, there are no reports on IRMP and learning systems in the literature. (2) Methods: We described and appraised our five-year single institutional experience with MIMVS in isolated valve surgery included in the Netherlands Heart Registry (NHR) and investigated root causes of high-impact complications. (3) Results: The 120-day and 12-month mortality were 1.1% and 1.9%, respectively, compared to the average of 4.3% and 5.3% reported in the NHR. The regurgitation rate was 1.4% compared to 5.2% nationwide. The few high-impact complications appeared not to be preventable. (4) Discussion: In MIMVS, freedom from major and minor complications is a strong indicator of an effective IRMP but remains concealed from physicians and patients, despite its relevance to shared decision making. Innovation adds to the complexity of MIMVS and challenges surgical competence. An IRMP system may detect and control new risks earlier. (5) Conclusion: An IRMP system contributes to an effective reduction of risks, pain and discomfort; provides relevant input for shared decision making; and warrants the safe introduction of new technology. Crossroads conclusions: investment in machine learning and AI for an effective IRMP system is recommended and the roles for commanding and operating surgeons should be considered.

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Rivaroxaban in patients undergoing surgical mitral valve repair

Cited by 10 publications

References 12 publications

Direct oral anticoagulation in atrial fibrillation and heart valve surgery—a meta-analysis and systematic review

Direct oral anticoagulation in atrial fibrillation and heart valve surgery—a meta-analysis and systematic review

Thromboembolic events and major bleeding with warfarin, non-vitamin K antagonist oral anticoagulants or antiplatelets following mitral valve repair: A systematic review and meta-analysis

At the Crossroads of Minimally Invasive Mitral Valve Surgery—Benching Single Hospital Experience to a National Registry: A Plea for Risk Management Technology

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