Mechanical Heart Valve Replacement Research Articles

Efficacy of human prothrombin complex concentrate in the treatment of warfarin overdose in patients receiving warfarin for mechanical heart valve replacement.

Warfarin, a widely utilized anticoagulant, is paramount for preventing thromboembolic events in patients with mechanical heart valve replacements. However, its narrow therapeutic index can lead to over-anticoagulation and overdose, resulting in serious health risks. This study examines the efficacy of human prothrombin complex concentrate (PCC) in managing warfarin overdose, in comparison with traditional treatments. A retrospective analysis was conducted on 162 adults who presented with warfarin overdose (INR > 5.0) at a tertiary care hospital between 2016 and 2020. Participants were divided into 2 groups-those treated with PCC (n = 57) and those treated with conventional methods (n = 105), including vitamin K and fresh frozen plasma. The primary outcome was the rate of reaching the target (International Normalized Ratio) INR within 24 hours. Secondary outcomes included transfusion requirements, thromboembolic events, adverse reactions, 30-day mortality, and length of hospital stay. PCC demonstrated significant efficacy, with 89.5% of patients achieving the target INR within 24 hours, compared to 64.8% in the control group (P < .05). The PCC group also had reduced transfusion requirements and a shorter average hospital stay. There was no significant difference in thromboembolic events or adverse reactions between the 2 groups, and the reduced 30-day mortality in the PCC group was not statistically significant. Human prothrombin complex concentrate is associated with rapid reaching the target INR, decreased transfusion needs, and shortened hospitalization, making it a promising option for warfarin overdose management. While the results are encouraging, larger, multicenter, randomized controlled trials are necessary to further validate these findings and optimize PCC administration protocols.

Influence of time in therapeutic range on postoperative complications in mechanical heart valve replacement patients operated with the indigenous TTK Chitra heart valve

Influence of time in therapeutic range on postoperative complications in mechanical heart valve replacement patients operated with the indigenous TTK Chitra heart valve

Comprehensive Management of Anticoagulants Induced Decompensated Severe Anemia in Postmitral Valve Replacement

Abstract Mechanical prosthetic valve needs consideration for anticoagulation. The objective of this case report was to know how maintenance of oral anticoagulant therapy is very important in patients, especially with mechanical heart valve replacement. It is the holistic management of mitral valve replacement (MVR) patients with high international normalized ratio (INR) (&gt;100), which led bleeding into the peritoneal cavity and causes decompensated severe anemia. Although it is a rare presentation for a patient of MVR with high INR level but which is most commonly presented for cerebrovascular accident. Anemia is a thoughtful worldwide problem that disturbs the quality of life in persons of all ages. A 28-year-old Indian woman with follow-up case of post-MVR came to the hospital with complaints of breathing difficulty, altered sensorium, pulse rate of 150–170 bpm (beats/min) irregularly irregular, blood pressure (80/50 mmHg), palpitation, and abdominal pain. Blood test report revealed her hemoglobin (Hb) was 3.2 g%, suggestive of severe anemia, INR was &gt;100 s. Hence, patient diagnosed as follow-up case of MVR (#27 mm mechanical bileaflet mitral valve prosthesis) with peritoneal bleeding, an oral anticoagulant with decompensated severe anemia managment should be done. Ended the progression of her hospitalization, she received four units of packed red blood cell transfusions; Vitamin K was given intravenous once daily for 2 days and no anticoagulant was given, so far, INR was high with serial monitoring of INR and Hb. Her symptoms of breathing difficulty, pain in abdomen, weakness and giddiness resolute by the finish of her hospital stay, and she recompensed to her oral anticoagulant therapy with improved Hb and hemodynamics. Disapprovingly high INR levels are classically related with bleeding disorders revealed on imperative indicators and hemodynamic variability. To our understanding, one of the lowermost noted Hb is because of bleeding due to very high INR, so monitoring of therapeutic INR level with anticoagulants is very-very important.

Prevalence of Guideline-Discordant Aspirin Use and Associated Adverse Events in Patients on Warfarin for Mechanical Valve Replacement

BackgroundFor patients on warfarin for mechanical heart valve replacement, the 2020 American College of Cardiology and American Heart Association Guidelines recommend only adding aspirin in patients with a specific indication for antiplatelet therapy. This contrasts with prior guidelines, which recommended concomitant aspirin therapy. We sought to assess the prevalence of guideline-discordant aspirin use among patients on warfarin for mechanical heart valve replacement and to compare adverse event rates among patients with and without concomitant aspirin. MethodsPatients on warfarin for mechanical heart valve replacement were identified from the Michigan Anticoagulation Quality Improvement Initiative registry. Patients with myocardial infarction, percutaneous coronary intervention, or coronary artery bypass within the past 12 months were excluded. Patients were divided into 2 groups based on aspirin use. Patient characteristics and bleeding and thromboembolic outcomes were compared. ResultsFour hundred forty-four patients met the inclusion criteria, with 341 (76.8%) on concomitant aspirin. The aspirin group was older (50.6 vs 46.3 years, P = .028) and had more hypertension (57.8% vs 46.6%, P = .046) but other patient characteristics were similar. The aspirin group had a higher rate of bleeding events (28.3 vs 13.3 per 100 patient-years, P < .001) and bleed-related emergency department visits (11.8 vs 2.9 per 100 patient-years, P = .001) compared with the non-aspirin group. There was no observed difference in rates of ischemic stroke (0.56 vs 0.48 per 100 patient-years, P = .89). ConclusionsA significant proportion of patients on warfarin for mechanical heart valve replacement are on guideline-discordant aspirin. Aspirin deprescribing in select patients may safely reduce bleeding events.

Optimization of anticoagulant therapy in patients undergoing mechanical heart valve replacement

Acquired heart defects have a high prevalence among patients of different age groups and represent a significant social problem. To date, surgery remains the only effective option to treat acquired heart disease, and replacement of the dysfunctional heart valves frequently relies on mechanical prosthetic heart valves which implantation requires lifelong anticoagulant therapy with vitamin K antagonists and constant monitoring of international normalised ratio. However, the optimal target range for international normalised ratio values remains poorly defined. Optimisation of the approaches to anticoagulant therapy for this category of patients is becoming increasingly important. This paper highlights the main problems and possible solutions for patients who have undergone implantation of mechanical heart valves and need constant intake of vitamin K antagonists.

Association of sex with major bleeding risks in sub-Saharian anticoagulated patients with mechanical heart valves: A cohort study from the Khartoum Emergency Salam Centre.

BackgroundRheumatic heart disease (RHD) with mechanical heart valve (MHV) replacement is common in Africa. However, MHV requires lifelong anticoagulation that could have a particular impact in women in reproductive age. MethodsWe report data of a prospective observational cohort study conducted between August 2018 and September 2019 in MHV patients in the Salam Centre for Cardiac Surgery built in Khartoum by Emergency, an Italian Non-Governmental Organization, to evaluate bleeding risk, its associated determinants, and the impact of lifelong anticoagulation in fertile women. ResultsWe studied 3647 patients (median age 25.1 years; 53.9% female). During follow-up [median time 1.1 (0.1–1.2) years], we recorded 85 major bleedings (rate 2.16 × 100 pt-years), Major bleedings occurred more frequently among women (64/85 cases, 75.3%; rate 3.0 × 100 pt-years), compared to men (21/85 cases, 24.7%; rate 1.16 × 100 pt-years) (RR 2.6; 95% CI 1.6–4.5; p = 0.0001). Multivariate analysis was performed to identify variables associated with major bleeding, and female sex was the only risk factor significantly associated, whereas aspirin treatment and higher INR target showed a non-significant trend for higher bleeding risk. Thirty-two/85 (37.6%) of major bleedings were metrorrhagias. When we calculate the incidence of major bleedings after the exclusion of gynecological events, no sex differences in the bleeding risk were found (HR 1.3, 95% CI 0.8–2.3; p = 0.3). ConclusionsBleeding risk of young MHV patients on oral anticoagulant therapy is higher among women, mainly due to metrorrhagia. Women in the reproductive life are at high risk for gynecological bleeding when treated with anticoagulants.

ANTICOAGULANTS AND EPISTAXIS: A COMPARATIVE ANALYSIS OF EPISTAXIS WITH WARFARIN AND DIRECT ORAL ANTICOAGULANTS

Anticoagulant therapy prevents and treats thromboembolic occasions like profound vein thrombosis, pneumonic embolism, and stroke. Warfarin, a vitamin K bad guy, has been the standard oral anticoagulant for quite some time. The study's main objective is to find that warfarin is associated with higher rates of epistaxis compared to direct oral anticoagulants. This cross-sectional study was conducted at Islamabad Medical and Dental College, Islamabad, from January 2023 till July 2023. Data was collected from 123 patients of both genders. The study population consists of adult patients prescribed anticoagulant therapy for various indications, including atrial fibrillation, venous thromboembolism, and mechanical heart valve replacement. Patients were identified from electronic medical records at the study site. In this study, a total of 123 adult patients receiving anticoagulant therapy were included. Among them, 62 patients were prescribed warfarin, and 61 were on direct oral anticoagulants (DOACs) (rivaroxaban, dabigatran, apixaban, or edoxaban). Warfarin and DOACs demonstrated similar safety profiles regarding other bleeding events and major adverse events. It is concluded that the study found no statistically significant difference in the incidence of epistaxis between the two treatment groups. Both Warfarin and DOACs showed similar safety profiles regarding other bleeding events and major adverse events, indicating that they are generally well-tolerated options for anticoagulation therapy in this patient population.

Adherence, belief, and knowledge about oral anticoagulants in patients with bioprosthetic heart valve replacement: a cross-sectional study.

Aims: To investigate adherence to oral anticoagulants among patients after mechanical heart valve (BHV) replacement and further examine the mediating role of medication belief in the relationship between knowledge and medication adherence. Background: The number of patients who undergo BHV replacement has increased in recent years. Short-term anticoagulant therapy is recommended for patients after BHV replacement. However, little is known about adherence to oral anticoagulant therapy and the underlying mechanisms among patients with BHV replacement. Methods: A cross-sectional study was conducted between September 2022 and November 2022. A convenience sample of 323 patients who underwent BHV replacement was recruited from a tertiary public hospital in Southwest China. Data were collected by using the 8-item Morisky Medication Adherence Scale, Beliefs about Medicines Questionnaire-specific, and the Knowledge of Anticoagulation Questionnaire. The mediation model was tested by Hayes's PROCESS macro. The STROBE checklist was used. Results: Approximately 17.3% of participants had low adherence, 47.1% had medium adherence, and only 35.6% reported high adherence to oral anticoagulants. Knowledge and necessity beliefs were positively related to medication adherence, while concern beliefs were negatively correlated with medication adherence. Medication belief mediated the relationship between knowledge and adherence to oral anticoagulants. Conclusion: Patients with BHV replacement demonstrated relatively low adherence to oral anticoagulant therapy. Efforts to enhance medication adherence should consider improving patients' knowledge and medication beliefs.

Frequency of prothrombin time-international normalized ratio monitoring and the long-term prognosis in patients with mechanical valve replacement

BackgroundThe study aimed to assess the correlation between the monitoring frequency of PT-INR and the long-term prognosis in patients with mechanical heart valve (MHV) replacement after discharge.MethodsThis single-center, observational study enrolled patients who underwent MHV replacement and discharged from June 2015 to May 2018. Patients or their corresponding family members were followed with a telephone questionnaire survey in July-October 2020. Based on monitoring intervals, patients were divided into frequent monitoring (FM) group (≤ 1 month) and less frequent monitoring (LFM) group (> 1 month). The primary endpoint was the composite of thromboembolic event, major bleeding or all-cause death. The secondary endpoints were thromboembolic event, major bleeding or all-cause death, respectively.ResultsA total of 188 patients were included in the final analysis. The median follow-up duration was 3.6 years (Interquartile range: 2.6 to 4.4 years). 104 (55.3%) patients and 84 (44.7%) patients were classified into the FM group and the LFM group, respectively. The FM group had a significantly lower incidence of the primary endpoint than the LFM group (3.74 vs. 1.16 per 100 patient-years, adjusted HR: 3.31 [95% CI 1.05–10.42, P = 0.041]). Secondary analysis revealed that the risk of thromboembolic events and all-cause death were also reduced in the FM group.ConclusionsThe management of warfarin treatment in patients after MHV replacement remains challenging. Patients with less frequent monitoring of PT-INR might have worse clinical prognosis than those with frequent PT-INR monitoring.

Management of Intracranial Hemorrhage in the Setting of Mechanical Heart Valve Replacement Therapy

The management of an intracranial hemorrhage in patients receiving anticoagulant therapy presents a significant challenge for medical professionals. Anticoagulant treatment is intended to prevent blood clotting, but it can worsen active brain bleeds. Despite this risk, avoiding the prothrombotic state caused by mechanical heart valves remains crucial. Guidelines on managing this issue are currently lacking, prompting a review that delves into embryonic development and anatomical functions of heart valves, valve replacement therapy for diseased valves, and the need for anticoagulants. Ultimately, recent literature and cases inform discussion regarding how best to manage intracranial hemorrhages in patients with mechanical heart valves. The expectation is that this examination will offer valuable perspectives on the handling of intracranial bleeding among individuals with mechanical heart valves and stimulate additional investigations in this intricate domain, particularly through the lens of applied mechanics.

The clicking sound after mechanical heart valve replacement: Can it hinder the level of physical activity in patient? - A case report.

The audible closure of the replaced mechanical heart valve, called ‘clicking sound’ has impact on the sleep and quality of life. We present a case of a 25-year-old male who reported five months after his mitral valve replacement, with restriction in physical activity, social and occupational participation due to disturbance caused by the constant clicking sound of the valve. Cardiac rehabilitation was implemented for four weeks. All the exercises were performed with the patient perceiving and understanding the safety of the clicking of valve to alleviate his fear. Correct patient education regarding clicking of replaced valve not only regained confidence, physical activity levels but also helped him to restart his job within four weeks of physiotherapy rehabilitation. Hence the impact of this study is that, the continuous valve noise though healthy can be a hinderance to physical activity levels and should not be underestimated.

Clinical Features and Survival Analysis of Patients after Mechanical Heart Valve Replacement, with an Emphasis on Prosthetic Valve Thrombosis.

Valvular heart diseases are highly prevalent in the world, and surgical valve replacement has improved patients' survival. To describe clinical and laboratory data of patients undergoing mechanical valve replacement, and to determine the incidence of prosthetic valve thrombosis (PVT). Retrospective cohort study with a follow-up of up to nine years. The study variables were collected from conventional and electronic medical charts. Statistical calculations were performed using the Jamovi software version 1.2.2.; a p<0.05 was considered statistically significant. Kaplan Meier curves were constructed, and Cox regression analysis was performed for analysis of factors related to mortality. A total of 473 patients were included, mean age of 46.9 ±11.3 years. Rheumatic disease was the most common etiology. In a mean follow-up period of 4.43 years, mortality rate was 16.1%. Patients with aortic prosthesis showed higher survival than patients with double implant (mitral and aortic) (p=0.026). Of the factors adjusted for mortality, only functional class and chronic renal failure showed statistically significant association. The incidence of PVT was 0.24/100 patients/year, and the first event occurred more than 1000 days after the implant. Smoking and pannus formation were significantly associated with PVT. No differences were found in INR variability between patients with and without thrombosis by prosthetic position, but significant differences were found in INR before thrombosis as compared with patients without thrombosis (INR= 2.20 [1.80-2.20] vs. 2.80 [2.20-3.40]; p= 0.040). The incidence of stroke and bleeding was 4.4% and 5.2% respectively. The study population was young, and rheumatic valve disease was common in this group. The prevalence of PVT was similar to that described in the literature, despite the low income and low educational level of our sample.

Development and validation of a mobile application based on a machine learning model to aid in predicting dosage of vitamin K antagonists among Indian patients post mechanical heart valve replacement

Patients who undergo heart valve replacements with mechanical valves need to take Vitamin K Antagonists (VKA) drugs (Warfarin, Nicoumalone) which has got a very narrow therapeutic range and needs very close monitoring using PT-INR. Accessibility to physicians to titrate drugs doses is a major problem in low-middle income countries (LMIC) like India. Our work was aimed at predicting the maintenance dosage of these drugs, using the de-identified medical data collected from patients attending an INR Clinic in South India. We used artificial intelligence (AI) - machine learning to develop the algorithm. A Support Vector Machine (SVM) regression model was built to predict the maintenance dosage of warfarin, who have stable INR values between 2.0 and 4.0. We developed a simple user friendly android mobile application for patients to use the algorithm to predict the doses. The algorithm generated drug doses in 1100 patients were compared to cardiologist prescribed doses and found to have an excellent correlation.

Combining portable coagulometers with the Internet: A new model of warfarin anticoagulation in patients following mechanical heart valve replacement.

Heart valve replacement, as a safe and effective treatment for severe valvular heart disease, can significantly improve hemodynamics in patients. However, such patients then require lifelong anticoagulant therapy. Warfarin, a cheap and highly effective vitamin K antagonist, remains the major anticoagulant recommended for lifelong use following mechanical heart valve replacement. However, the effect of warfarin anticoagulant therapy is complicated by physiological differences among patients and non-compliance with treatment at different degrees. Effective management of warfarin therapy after heart valve replacement is currently an important issue. Portable coagulometers and the emergence of the Internet have provided new opportunities for long-term management of anticoagulation therapy, but the safety and affordability of this approach remain to be fully evaluated. This paper reviews recent progress on the use of portable coagulometers and the Internet in the management of warfarin anticoagulation therapy following mechanical heart valve replacement, which offers opportunities for reducing complications during postoperative anticoagulation and for facilitating patient compliance during follow-up.

Oral anticoagulant management of patients with mechanical heart valves at the Salam Centre of Khartoum: Observations on quality of anticoagulation and thrombotic risk

IntroductionRheumatic heart disease with mechanical heart valve (MHV) replacement is common in Africa. However, MHV requires long-life anticoagulation and managing this can be challenging. Methods and resultsWe report data of a prospective observational study conducted between August 2018 and September 2019 in MHV patients in the Salam Centre for Cardiac Surgery built in Khartoum, by Emergency, an Italian Non-Governmental Organization, to evaluate the quality of anticoagulation control and the risk of thrombotic complications. ResultsWe studied 3647 patients (median age 25.1 years; 53.9 % female). Median Time in Therapeutic Range (TTR) was 53 % (interquartile range 37 % to 67 %) and 70 thrombotic events (rate 1.8 × 100 pt-years [95 % CI 1.38–2.23]) were recorded. Among patients in the first quartile of TTR (≤37 %), we recorded 34/70 (48.6 %) of all thrombotic events (rate 3.7 × 100 pt-years [95 % CI 2.5–5.1]), with a high mortality rate (2.2 × 100 pt-years [95 % CI 1.3–3.3]). In patients with guideline-recommended TTR (≥65 %) the event rate was 0.8 × 100 pt-years for thrombotic events [95 % CI 0.3–1.5] and 0.4 × 100 pt-years for mortality [95 % CI 0.1–0.9].Multivariable analysis showed that having a TTR in the lowest quartile (≤37 %) and being noncompliant are significantly associated with increased thrombotic risk. Aspirin use or different valve type did not influence the thrombotic risk. Almost 40 % of all thromboembolic complications could have been potentially prevented by further improving VKA management to obtain a TTR > 37 %. ConclusionThe thrombotic risk of MHV patients on VKAs living in a low-income country like Sudan is associated with low quality of anticoagulation control. Efforts should be made to decrease the number of non-compliant patients and to reach a guideline-recommended TTR of ≥65 %.

Rosendaal linear interpolation method appraising of time in therapeutic range in patients with 12-week follow-up interval after mechanical heart valve replacement.

BackgroundThe objective of this study was to evaluate the quality of anticoagulation by the time in therapeutic range (TTR) for patients with 12-week INR follow-up interval.Materials and methodsFrom January 2018 to December 2020, a selective group of patients who underwent mechanical valve replacement and followed up at our anticoagulation clinic for adjustment of warfarin dose were enrolled. The incidences of complications of anticoagulation therapy were reported by linearized rates. TTR was calculated by the Rosendaal linear interpolation method.ResultsTwo hundred and seventy-four patients were eligible for this study. The mean age of these patients was 52.8 ± 12.7 years, and 65.7% (180 cases) of them were females. The mean duration of warfarin therapy was 16.7 ± 28.1 months. A total of 1309 INR values were collected, representing 66789 patient days. In this study, the mean TTR was 63.7% ± 18.6%, weekly doses of warfarin were 20.6 ± 6.0 mg/weekly, and the mean monitoring interval for the patient was 53.6 ± 27.1 days. There were 153 cases in good TTR group (TTR ≥ 60%) and 121 cases in poor TTR group (TTR < 60%). The calculated mean TTR in both groups was 42.6% ± 22.1% and 74.8% ± 10.4%, respectively. Compared with the TTR ≥ 60% group, the TTR < 60% group exhibited a more prevalence of female gender (p = 0.001), atrial fibrillation (p < 0.001), NYHA ≥ III (p < 0.001), and lower preoperative left ventricular ejection fraction (LVEF, p = 0.032). In multivariate analysis, female gender (p = 0.023) and atrial fibrillation (p = 0.011) were associated with TTR < 60%. The incidence of major bleeding and thromboembolic events was 2.7% and 1.1% patient-years, respectively. There was one death which resulted from cerebral hemorrhage. The incidence of death was 0.5% patient-years. The difference in anticoagulation-related complications between the TTR < 60% group and the TTR ≥ 60% group was not statistically significant.ConclusionFor patients with stable international normalized ratio monitoring results who are follow-up at anticoagulation clinics, a 12-week monitoring interval has an acceptable quality of anticoagulation. The female gender and atrial fibrillation were associated with TTR < 60%.

A Study of the Nursing Intervention Based on Self-Efficacy Theory for Patients After Mechanical Heart Valve Replacement: A Randomized Controlled Trial.

AimTo explore the practicability and efficiency of self-efficacy intervention on the nursing for patients after mechanical heart valve replacement (MHVR), so as to provide a theoretical and data foundation for the implementation of self-efficacy intervention in clinical practice.MethodsThis study adopted a randomized controlled trial (RCT). A total of 140 patients undergoing MHVR were randomly divided into the experimental group (normal nursing + self-efficacy intervention) or the control group (normal nursing only) based on a random number table. The primary goal was to evaluate the effect of self-efficacy theory on the self-efficacy of postoperative MHVR patients by General Self-Efficacy Scale (GSES). The secondary goal was to assess the improvement of mental health of postoperative patients as well as their pain through Symptom Checklist 90 (SCL-90) and the visual analogue scale (VAS). The incidence of infection during hospitalization was analyzed, as well as the medication compliance of patients during 3-month follow-up after discharge.ResultsFinally, 136 patients completed the whole trial. The GSES score of the experimental group was notably superior over the control group (p < 0.001), and the SCL-90 scores were lower over the control group. The VAS score of the experimental group was remarkably lower than that of the control group (p < 0.001). The incidence of infection in the experimental group was lower than that in the control group (p = 0.026). The medication compliance of the experimental group was superior to that of the control group (p = 0.030).ConclusionSelf-efficacy intervention for patients after MHVR could mobilize their self-efficacy, enhance their postoperative medication compliance, and improve their postoperative recovery. This study provides evidence-based medicine (EBM) evidence for the application of self-efficacy theory to postoperative nursing for patients receiving MHVR.

Pregnancy Outcomes in Women With Mechanical Valve Prostheses Using Vitamin K Antagonist Therapy: The Experience of the Salam Centre for Cardiac Surgery in Sudan.

Pregnancy and childbirth on anticoagulants after mechanical heart valve replacement present a high risk of complications for both mother and baby. On top of pregnancy worsening the mother's cardiac function, anticoagulant therapy itself is a crucial problem. A safe and effective anticoagulation regimen for both mother and fetus is not possible. The most effective drugs for preventing valve thrombosis are VKAs, whose dosage needs to be adjusted with frequent INR checks. Moreover, VKAs can have embryopathic and teratogenic action. Patients in follow-up and anticoagulant treatment at the Salam Centre for Cardiac Surgery in Sudan live spread out over a large area where transport to the Center is generally difficult; pregnancy treatment has, therefore, been adapted to the limitations of reality. Pregnancy is discouraged and contraception and therapeutic abortion are recommended, but this guidance frequently goes unheeded. Here we describe maternal and fetal outcomes in 307 consecutive pregnancies recorded by staff at the oral anticoagulant clinic (OAC) from April 2017 to November 2021. Out of 307 pregnancies, there were 15 maternal deaths (4.9%), 24 thrombotic events (7.8%) and 22 major bleedings (7.2%). Fifty pregnancies (16.3%) were terminated by therapeutic abortion. Only 47.6% of pregnancies had good maternal and neonatal outcomes. Data clearly show that, due to the complexity of pregnancy in women with mechanical heart valves and the scarcity of tertiary healthcare services in the area where patients live, maternal mortality is at an unacceptable level and requires a structured, multi-disciplinary intervention.

P371 1 YEAR OUTCOME OF BICARBON AORTIC MECHANICAL VALVE IN LOW–INR REGIMEN: RESULTS FROM SURE–AVR REGISTRY

Abstract Background The drawback of using mechanical valve is lifelong anticoagulation use, and close monitoring is required to prevent postoperative complications, including thromboembolism and anticoagulation–related bleeding. Moderate anticoagulation after mechanical heart valve replacement has been proposed to reduce these risks. The present study aimed to evaluate the safety and feasibility of reduced oral anticoagulation after Bicarbon aortic mechanical valve replacement. Methods SURE–AVR is a propsective, multinational registry of patients undergoing aortic valve replacement. Between July 2018 and October 2020, among subjects undergoing AVR with Bicarbon valve in the SURE–AVR registry, 108 were assigned at discharge to low–INr regimen (international normalized ratio 1.5–2.5). Mean INr at discharge was 1.8+/–0.5 and 2.2+/–0.4 at 1 year. in–hospital and post–discharge outcomes up to 1 years were collected. The mean age was 55.5 +/–10.6 years old (range 25–82). Concomitant procedures included coronary artery bypass grafting (14.6%), mitral valve procedure (3.7%) and myectomy (1.9%). The follow–up duration averaged 1 year (361.8 +/– 258 days). Results No bleeding events were reported in the late follow up. The low–INR regimen did not affect the thromboembolism rates, since no stroke or transient ischemic attack were reported post–operatively at each time point. No in–hospital or late deaths were reported among the 108 subjects analyzed. In the early period (&amp;lt;30 days), three reinterventions occurred: two because of postoperative bleeding requiring thoracotomy and one due to pericardial effusion. In the late postoperative period two reinterventions with device explant occurred (one for non–structural valve dysfunction and one for endocarditis (1.2%). Conclusion The results of the SURE–AVr Registry demonstrated that the proposed Lower–INR Target is safe and feasible after Bicarbon aortic mechanical valve replacement. The low–intensity anticoagulation strategy is associated with a low risk of hemorrhagic events without any increase of thromboembolic complications.

Relationship Between Family Functioning and Medication Adherence in Chinese Patients With Mechanical Heart Valve Replacement: A Moderated Mediation Model

Background: Medication adherence is crucial for patients with mechanical heart valve replacement. Although families functioning is positively associated with medication adherence, little is known about the underlying mechanisms. Objective: To test whether family functioning affects medication adherence through illness perceptions and whether this mediating effect was moderated by medication literacy. Methods: 319 patients after mechanical heart valve replacement were included in this cross-sectional study from June 2021 to October 2021. Data regarding family functioning, illness perceptions, medication adherence, and medication literacy were collected through questionnaires. The moderated mediation model was examined by Hayes’s PROCESS macro, based on the bootstrapping method. Results: The results revealed illness perceptions partially mediated the association of family functioning on medication adherence [β = 0.08, 95% confidence intervals: (0.04, 0.12)], and this effect was stronger for patients with low medication literacy than those with high literacy [β = −0.36, 95% CI: (−0.50, −0.22)]. Furthermore, the relationship between family functioning and medication adherence was only significant in patients with low medication literacy [β = 0.36, 95% CI: (0.23, 0.50)]. Conclusion: The mediating effect of illness perceptions between family functioning and medication adherence was moderated by medication literacy. Efforts to improve medication adherence by targeting at improving family functioning may be more effective when considering illness perceptions, especially for patients with limited medication literacy.