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Implications of using different methods to characterise anticoagulant control in patients with second generation mechanical heart valve prostheses.

ABSTRACT: OBJECTIVE:Characterisation of anticoagulant control is fundamental to investigations of its association with clinical outcome. Anticoagulant control depends on several factors. This paper aims to illustrate the implications of different methods for measuring and analysing anticoagulant control in patients with second generation mechanical heart valve prostheses. METHODS:International normalised ratio (INR) data collected during the 10-year follow-up of a randomised controlled trial were analysed. We considered the influence of: 3 different target INR ranges; anticoagulant control expressed as the proportion of INR readings (PoR) vs. anticoagulant control follow-up time (PoT); 3 ways of describing the profile of anticoagulant control over time. RESULTS:Different target INR ranges dramatically influenced derived measures of anticoagulant control; the PoT within the target range varied from 88% for the widest to 28% for narrowest range. Overall distributions of PoR and PoT observations were similar but differed by up to ± 20% for individuals; PoT exceeded PoR when control was good but was less than PoR when control was poor. Classifying PoT outside the target range showed that widely varying combinations of PoT too high and too low are possible across individuals. CONCLUSIONS:Researchers' choices about methods for measuring and quantifying anticoagulant control markedly influence the values derived from INR readings. The use of different methods across studies makes it difficult or impossible to compare findings and to establish an evidence base for clinical practice. Methods for quantifying anticoagulant control should be standardised.

SUBMITTER: Fiorentino F

PROVIDER: S-EPMC4079318 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Implications of using different methods to characterise anticoagulant control in patients with second generation mechanical heart valve prostheses.

Fiorentino Francesca F Rogers Chris A CA Bryan Alan J AJ Angelini Gianni D GD Reeves Barnaby C BC

PloS one 20140702 7

<h4>Objective</h4>Characterisation of anticoagulant control is fundamental to investigations of its association with clinical outcome. Anticoagulant control depends on several factors. This paper aims to illustrate the implications of different methods for measuring and analysing anticoagulant control in patients with second generation mechanical heart valve prostheses.<h4>Methods</h4>International normalised ratio (INR) data collected during the 10-year follow-up of a randomised controlled tria ...[more]

PMID: 24988447

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Project description:BackgroundSafety-net hospitals care for a high proportion of uninsured/underinsured patients who may lack access to longitudinal care. The present study characterized the use of mechanical valves and clinical outcomes of surgical aortic valve replacement at safety net hospitals.MethodsAll adults undergoing surgical aortic valve replacement were abstracted from the 2016-2018 Nationwide Readmissions Database. Hospitals were divided into quartiles based on volume of all Medicaid and uninsured admissions, with the highest quartile defined as safety net hospitals. Multivariable regression was used to determine the association between safety net hospitals and several outcomes including mechanical valve use, perioperative complications, index hospitalization costs, 90-day readmission, and complications at readmission.ResultsOf the 94,580 patients undergoing surgical aortic valve replacement, 14.5% of operations were at safety net hospitals. Patients at safety net hospitals more commonly received mechanical valves (20.3% vs 16.9%, P < .01) compared to those at non-safety net hospitals. After adjustment, safety net hospitals remained associated with a greater odds of mechanical aortic valve use (adjusted odds ratio, 1.13, 95% confidence interval 1.05-1.21). However, operation at safety net hospitals was also associated with increased odds of perioperative complications (adjusted odds ratio 1.10, 95% confidence interval 1.03-1.17) and higher hospitalization costs (β coefficient +$6.15K, 95% confidence interval +$5.26 - +$7.03) despite similar 90-day readmissions. Upon readmission, safety net hospitals patients were more likely to experience mortality (adjusted odds ratio 1.87, 95% confidence interval 1.18-2.98) and stroke (adjusted odds ratio 2.41, 95% confidence interval 1.23-4.70) compared to those at non-safety net hospitals.ConclusionHospital safety net status is associated with increased use of mechanical valves for surgical aortic valve replacement despite also being associated with increased perioperative complications, costs, and significant complications upon readmission. Ability to access adequate follow-up care may be an important consideration for surgical aortic valve replacement at safety net hospitals.

Project description:ObjectivesThe prosthesis type for multiple valve surgery (replacement of two or more diseased native or prosthetic valves, replacement of two diseased valves with repair/reconstruction of a third, or replacement of a single diseased valve with repair/reconstruction of a second valve) remains inadequately evaluated. The clinical performance of multiple valve surgery with bioprostheses (BP) and mechanical prostheses (MP) was assessed to compare patient survival and composites of valve-related complications.MethodsBetween 1975 and 2000, 1245 patients had multiple valve surgery (BP 785, mean age 62.0 ± 14.7 years; and MP 460, mean age 56.9 ± 12.9 years). There were 1712 procedures performed [BP 969(56.6%) and MP 743(43.4%). Concomitant coronary artery bypass (conCABG) was BP 206(21.3%) and MP 105(14.1%) (p = 0.0002). The cumulative follow-up was BP 5131 years and MP 3364 years. Independent predictors were determined for mortality, valve-related complications and composites of complications.ResultsUnadjusted patient survival at 12 years was BP 52.1 ± 2.1% and MP 54.8 ± 4.6% (p = 0.1127), while the age adjusted survival was BP 48.7 ± 2.3% and MP 54.4 ± 5.0%. The predictors of overall mortality were age [Hazard Ratio (HR) 1.051, p < 0.0001], previous valve (HR 1.366, p = 0.028) and conCABG (HR 1.27, p = 0.021). The actual freedom from valve-related mortality at 12 years was BP 85.6 ± 1.6% and MP 91.0 ± 1.6% (actuarial p = 0.0167). The predictors of valve-related mortality were valve type (BP > MP) (2.61, p = 0.001), age (HR 1.032, p = 0.0005) and previous valve (HR 12.61, p < 0.0001). The actual freedom from valve-related reoperation at 12 years was BP 60.8 ± 1.9% and MP85.6 ± 2.1% (actuarial p < 0.001). The predictors of valve-related reoperation were valve type (MP > BP) (HR 0.32, p < 0.0001), age (HR 0.99, p = 0.0001) and previous valve (HR 1.38, p = 0.008) CONCLUSIONS: Overall survival (age adjusted) is differentiated by valve type over 10 and 12 years and valve-related mortality and valve-related reoperation favours the use of mechanical prostheses, overall for multiple valve surgery.

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Implications of using different methods to characterise anticoagulant control in patients with second generation mechanical heart valve prostheses.

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Implications of using different methods to characterise anticoagulant control in patients with second generation mechanical heart valve prostheses.

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