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

Havers-Borgersen, Eva; Butt, Jawad H; Vinding, Naja Emborg; Torp‐Pedersen, Christian; Gislason, Gunnar; Køber, Lars; Fosbøl, Emil Loldrup

doi:10.1016/j.jtcvs.2019.02.061

Cited by 24 publications

(20 citation statements)

References 24 publications

(45 reference statements)

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“…Patients with contraindications to anticoagulation or with anticipated poor compliance with regular testing may not derive the same benefit from mechanical valve use. This is supported by data demonstrating that patients with less time with a therapeutic international normalized ratio (INR) have a higher risk of thromboembolic events and that anticoagulation variability may decrease survival 12,13 . Thus, though the overall risk of anticoagulation‐related complications is relatively low, patient factors must be heavily weighted particularly in the selection of mechanical valve replacement to maintain the mortality benefit.…”

Section: Discussionmentioning

confidence: 99%

Outcomes of tissue versus mechanical aortic valve replacement in patients 50 to 70 years of age

et al. 2020

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Background Societal guidelines suggest that aortic valve replacement (AVR) in patients age 50 to 70 years can be performed with either bioprosthetic or mechanical valves. This study reviewed outcomes between these valve types among patients aged 50 to 70 years undergoing AVR. Methods We examined adult patients 50 to 70 years undergoing isolated AVR with a mechanical or bioprosthetic valve at a single institution between 2010 and 2018. Kaplan‐Meier analysis was used to evaluate longitudinal survival and multivariable Cox regression analysis was used for risk adjustment. A propensity‐matched analysis was performed as well. Results A total of 723 patients underwent isolated AVR with 467 (64.6%) receiving a bioprosthetic valve. At baseline, patients undergoing bioprosthetic AVR were older (median 65 vs 60 years; P < .001). One‐year survival was comparable, however, survival at 5 years was significantly higher among patients undergoing mechanical AVR (95.5% vs 82.6%; P = .010). Among the 196 matched pairs, bioprosthetic AVR was associated with an increased adjusted hazard for death (hazards ratio, 3.29; P < .001). Additionally, 5‐year freedom from stroke and bleeding were similar following matching, though mechanical AVR was associated with a greater freedom from repeat valve intervention (97.5% vs 92.9%; P = .020). Conclusion In patients age 50 to 70, mechanical AVR is associated with improved long‐term survival and freedom from repeat aortic valve intervention. Further large cohort studies should be performed to explore the potential benefits of mechanical valve replacement in this age range.

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Section: Discussionmentioning

confidence: 99%

Outcomes of tissue versus mechanical aortic valve replacement in patients 50 to 70 years of age

et al. 2020

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“…Mechanical valves have historically been favored for younger patients due to long-term durability, however, their use necessitates lifelong anticoagulation with warfarin which imparts a risk of anticoagulation-related adverse events. Anticoagulation for mechanical valves requires diligent management to ensure patients are within the target international normalized ratio (INR) range for their specific valve type since rates of valve-related and anticoagulation-related adverse events have been correlated to the duration of time spent outside the therapeutic range (3). It is unknown whether slight deviations in INR may lead to adverse events that nullify the benefits associated with the durability of mechanical valves.…”

Section: Introductionmentioning

confidence: 99%

Outcomes related to anticoagulation management for mechanical valve replacements

Huckaby¹,

Seese²,

Gleason³

et al. 2021

J Thorac Dis

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Background: This study evaluates anticoagulation management and its impact on longitudinal clinical outcomes in patients undergoing mechanical valve replacement. Methods: Patients undergoing mechanical mitral valve replacement (MVR) or aortic valve replacement (AVR) from 2010-2018 at a single center were included. Patients were stratified into therapeutic and non-therapeutic anticoagulation groups based on the median percentage of international normalized ratio (INR) values within the reference range (2.0-3.0 for AVR, 2.5-3.5 for MVR) during the first post-operative year. Using Cox regression analysis, comorbidity-adjusted survival and freedom from adverse events were compared. Results: Six hundred and fifty-one patients underwent mechanical valve replacement (166 MVR, 485 AVR). Comorbidity-adjusted survival was similar in the MVR and AVR cohorts (P=0.23). There was a median of 27 [interquartile range (IQR): 14-42] INRs drawn per patient in the first post-operative year. The median percentage of INRs within the reference values during the first post-operative year was 42.85% (IQR: 30.77-53.95%), with the majority of non-therapeutic INRs being subtherapeutic (34.51%; n=6,864). There were no significant differences in adjusted survival between the therapeutic and non-therapeutic groups [hazard ratio (HR): 1.12, P=0.73]. Within the first post-operative year, there were no significant differences in stroke, major bleeding, peripheral non-stroke arterial thromboembolism, and readmission for intravenous heparin in the therapeutic and non-therapeutic groups. Conclusions: Taking into account relevant comorbidities and valve type, patients with a larger proportion of non-therapeutic INRs during the first post-operative year demonstrated no difference in longitudinal clinical outcomes. Further research into more standardized INR monitoring and potentially expanded INR target ranges for patients undergoing mechanical valve replacement is warranted.

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“…The efficacy and safety of warfarin depend on the ratio of the international normalized ratio (INR). The INR follow-up of these patients is very important, followed by bleeding and thrombosis occurrence when the INR is out of the safe range (4)(5)(6). In a cohort study, the incidence rates of thromboembolism and bleeding were estimated at 1.8 and 2.2, as well as 4.4 and 4.6 in patients with aortic valve replacement (AVR) and mitral valve replacement (MVR), respectively (7).…”

Section: Introductionmentioning

confidence: 99%

Retrospective investigation of anticoagulant complications in long term after mechanical heart valve replacement surgery in Turkey

Kankaya

Bilik

Gencpinar

2020

ircmj

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Background: Patients with mechanical heart valve replacement surgery (MHVRS) should be followed up in terms of prosthetic valve-related and open heart surgery complications. This study aimed to determine the anticoagulant complications in long term in patients with MHVRS. Methods: This retrospective and descriptive study was conducted in a university hospital, İzmir, Turkey. The data were collected from July to December 2019. In total, 73 patients referring for regular check-ups to the hospital with intervals not exceeded more than 90 days, and those who had international normalized ratio (INR) measurements for January-April-July-October 2018 were included in this study. Results: The mean age of the patients was obtained at 58.98±12.89 years, and 53.4% (n=39) of the cases were male. Moreover, the mean follow-up period was estimated at 65.98±28.47 months. According to the results, complications developed in 60 patients (82.2%). The first hospitalized unit was the emergency department. The factors affecting the development of complications after MHVRS were evaluated, and a difference was found regarding gender (X2=6.18, P=0.013), comorbidities (X2=25.58, P=0.018), and monthly referral for regular check-ups to the hospital (X2=5.20, P=0.023). There was no relationship between the INR levels and the development of complications. Furthermore, the results of evaluating the factors affecting the number of hospitalizations after MHVRS revealed that monthly referral to hospital for check-ups (t=3.18, P=0.002) and history of previous valve surgery (Z=201.00, P=0.03) affected the number of hospitalizations. Conclusions: It was observed that patients frequently refer to the emergency department and struggled with various complications. Moreover, it was found that the patients had frequent bleeding and refer to the emergency service repeatedly. Accordingly, there is a need for interventional studies to reduce postoperative complications and provide the therapeutic INR level.

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

Cited by 24 publications

References 24 publications

Outcomes of tissue versus mechanical aortic valve replacement in patients 50 to 70 years of age

Outcomes of tissue versus mechanical aortic valve replacement in patients 50 to 70 years of age

Outcomes related to anticoagulation management for mechanical valve replacements

Retrospective investigation of anticoagulant complications in long term after mechanical heart valve replacement surgery in Turkey

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