Background: A balance between the benefits and risks of anticoagulation in patients with mechanical valve requires a holistic approach. Perspectives of the treating doctors will help in identifying areas for improvement. Objective: To explore the facilitators and barriers to anticoagulation in patients undergoing valve replacement surgery from the perspectives of treating doctors of a government institution. Methods: A qualitative phenomenological study was conducted among nine doctors of the cardiothoracic and vascular surgery department. Data were collected through in-depth semi-structured interviews. Interviews were audiorecorded, transcribed verbatim, and analysed using reflexive thematic analysis. These findings were subsequently interpreted using the Capability–Opportunity–Motivation–Behaviour (COM-B) framework. Results: Five interrelated themes emerged 1) Therapeutic balance and risk mitigation 2) Information and engagement 3) Monitoring and accessibility 4) health-system constraints 5) Integrated and Patient centered care. These themes aligned with the COM B model. Conclusion: Safe anticoagulant extends beyond prescribing. It requiresexpertise of the doctor, patient engagement, regular monitoring and supportive system. Appropriate anticoagulation is achieved through care continuity, adherence, and by ensuring patient safety.
Valvular heart disease due to rheumatic heart disease in the young, and degenerative changes in the elderly, causes significant morbidity in the Asia Pacific region.1Despite the development of transcatheter interventions, valve replacement surgeries are required for advanced lesions to restore cardiac function and improve quality of life. Mechanical prosthetic valves necessitates lifelong oral anticoagulant therapy to prevent valve thrombosis and thromboembolism.2 While bioprosthetic valves reduce the need for long-term anticoagulation,short durability and degeneration with time are its limitationsespecially in the young.3Appropriate prosthetic valve selection along withoptimal anticoagulation are determinants of long-term clinical outcomes.4The choice of prosthetic valve involves shared decision-making process which takes into account patient’s values and preferences. This also involves discussion on indications and risks of anticoagulation.
Recent guidelines support the use of novel oral anticoagulants(NOAC) like apixaban, dabigatran, edoxaban, and rivaroxaban for aortic stenosis, aortic regurgitation or mitral regurgitation presenting with AF it is not preferred in those with significant mitral stenosis or mechanical prostheses.5Vitamin K antagonists(VKAs) like warfarin and Acenocoumarol remain the standard anticoagulant therapy for patients with mechanical prosthetic heart valves. The target international normalized ratio (INR) is between 2 and 3 is indicated in patients with AF to maintain therapeutic range and minimize thromboembolic and bleeding complications.5 Anticoagulation in such patients is a lifelong intervention that requires clinical support, frequent lab or in clinic testing, dose adjustment and patient education.
The challenges in management of patients with VKAsare attributed to its narrow therapeutic window, susceptibility tofood and drug interactions as well as genetic influenceresulting in inter individual variability.6The clinical complexities owing to subtherapeutic anticoagulation or over anticoagulation demands continuous risk-benefit assessment providing individualised therapeutic decision-making.Patients’education plays a key role in achieving stable anticoagulation in the therapeutic range. Paucity of good-quality evidencestill discourages genomic guided dose titration.5Multiple patient, clinician, and system related factors poses challenges and influence optimal anticoagulation. These challenges require strategies that can integrate clinical expertise with patient-centered care and system-level support.
Most existing literature on anticoagulation after valve replacement focuses on efficacy, therapeutic outcomes, anticoagulant selection, adherence and predictors of complications. There is a gap in understanding the experiences, perceptions, and clinical reasoning of doctors responsible for prescribing and monitoring anticoagulant therapy. There are studies exploringstakeholders experiences of anticoagulation, however evidence regarding clinician’s perspectivesparticularly in tertiarycare hospitals in low and middle-income countries remains limited.7–11 A phenomenological approach is for exploring this area was adopted as it helps to understand how individuals experience and interpret a particular phenomenon within their everyday professional practice. This study was done with an objective to explore the facilitators and barriers to anticoagulant use in patients undergoing valve replacement surgery from the perspectives of treating doctors in a tertiary-care teaching hospital in Kerala, India.
phenomenological approach to explore treating doctor’s perceptions and experiences regarding anticoagulant use in patients undergoing valve replacement surgery. The study was conducted in the Department of Cardiovascular and Thoracic Surgery (CTVS) at Government Medical College, Kottayam, Kerala, India. Participants comprised doctors involved in the management of patients undergoing valve replacement surgery(n=9).A purposive sampling strategy was adopted and recruitment continued until data saturation was achieved when no new concepts or themes emerged during successive interviews. Data were collected through individual in-depth interviews conducted using a semi structured interview guide. The guide explored theparticipants’ experiences, perceived facilitators, barriers, practices and strategiesregarding anticoagulant use. Interviews were conducted at a time convenient for participants. Each interview lasted approximately 20–30 minutes and was audio-recorded after obtaining written informed consent. Audio recordings were transcribed verbatim using TurboScribe AI. Transcripts were reviewed alongside the recordings to ensure accuracy before analysis. All identifying information was removed to maintain participant confidentiality.Data were analysed using Braun and Clarke's Reflexive Thematic Analysis (RTA),with the QDA Miner Lite for data management and coding organization.Analysis was iterative and inductive, involving familiarisation of transcripts, generation of initial codes, theme construction,reviewing and refining themes, defining and naming themes and synthesis of themes.Following inductive thematic analysis, the final themes were interpreted using the CapabilityOpportunityMotivation Behaviour (COM-B) model.This sequential approach preserved the inductive integrity while providing a behavioural interpretation of the findings.Credibility,dependability,confirmability and transferability wereensured. Ethical approval was obtained from the Institutional Review Board of Government Medical College, Kottayam (IRB 189/2024 dated 05.11.2024) before commencement of the study.The patient perceptions explored as a part of the main study has been published.11 Written informed consent was obtained from all participants before the interviews. Participation was voluntary, and Confidentiality was maintained by anonymising transcripts and removing all personal identifiers before analysis. Audio recordings and transcripts were securely stored and accessed only by the research team.
Participants included faculty members and senior residents (n=9) of the CTVS department.A total of 297 initial codes were generated andconsolidated into 72 refined codes, which were subsequently organised into 14 conceptual categories and five themes. Table 1 summarizes the codes and themes generated. The Five interrelated themes identified were (a) Therapeutic balance and Risk Mitigation (b) Information and patient engagement (c) Monitoring and Accessibility (d) Health-system constraints (e) Integrated and patient-centered care. These themes encompassinformation, education, communication as the key facilitators along with monitoring and shared decision-making. The key barriers include the constraints in accessibility encroaching personal hours amidst heavy workloadand need for integrated approach with a registry based separate warfarin/anticoagulant clinic, need for incorporation and streamlining of digital applications and educational videos.
Table 1:Codes and Themes
|
Themes |
Examples of Initial Codes |
Initial Codes(n) |
Refined Codes(n) |
Conceptual Focus |
|
1.Therapeutic Balance and Risk Mitigation |
Maintain optimum INR, bleeding risk, thrombotic risk, "double-edged sword", individualise therapy, prosthetic valve thrombosis, dose adjustment, balancing risk, monitor PT/INR, evidence-based decision, valve type influences therapy, patient comorbidities, therapeutic range, clinical judgement, risk stratification, anticoagulant selection, prevent stroke, prevent bleeding |
82 |
18 |
1.Clinical decision-making 2.Therapeutic balancing 3. Risk |
|
2. Information and Patient Engagement |
Patient willingness, lifelong medication, patient education, counselling before discharge, explain complications, adherence, health literacy, caregiver involvement, shared decision-making, dietary advice, compliance, psychological readiness, follow-up attendance, understanding treatment, medication awareness, reinforce education |
67 |
16 |
4. Patient capability 5. Adherence barriers 6. Shared responsibility |
|
3. Monitoring and Accessibility |
Regular INR monitoring, frequent follow-up, mobileconsultation, report INR, dose modification, outpatient review, communication, continuity of care, laboratory monitoring, monitoring schedule, review reports, clinician accessibility, documentation |
58 |
14 |
7.Monitoring systems 8.Communication 9. Guideline directed practice |
|
4.Health-System Constraints |
Cost of INR, expensive medicines, travel burden, financial difficulty, missed appointments, heavy workload, limited resources, accessibility, poor follow-up, rural patients, laboratory availability, system constraints |
46 |
12 |
10. Economic and Logistical barriers11.Organisationalsupport 12. Multidisciplinary support |
|
5.Integrated and Patient-Centered Care |
Warfarin clinic, dedicated anticoagulation clinic, valve clinic, institutional protocol, multidisciplinary team, digital follow-up, mobile application, educational videos, dedicated staff, standard operating procedure, quality improvement, patient-centered care |
44 |
12 |
13.Organisational improvements 14. Technology enabled care |
|
5 Themes |
297 |
72 |
14 Concepts |
Table 2 summarizes the 14 conceptual categories which were eventually merged into 5 themes. These themes were then mapped with the COM-B model as planned in the protocol. Theme 1, Therapeutic balance and risk mitigation involved Psychological Capability through specializedknowledge, interpretation of INR and assessment of risks, Physical Opportunity throughindividualized dose adjustments and Reflective Motivationas they were motivated by preventing life-threatening complications while maintaining therapeutic efficacy. Theme 2, Information and Patient Engagement involved psychological capabilityas understood by the fact that the participants repeatedly described patient understanding, health literacy, and awareness of lifelong treatment as prerequisites for successful anticoagulation, Social Opportunity based on the counselling, family involvement, and shared decision-making and reflective motivation of both patients and doctors. While patients’ willingness to adhere reflected reflective motivation, clinicians were motivated to invest time in education to improve long-term outcomes. Theme 3, Monitoring and Accessibility demonstrates Intellectual capability as depicted by regular PT/INR monitoring, interpretation of results, and dose modification. Telephonic follow-up and outpatient reviews created physical and social opportunities for ongoing care. Follow-up practices and clinician’s commitment for patient engagement reflected both automatic and deliberate professional motivation. Theme 4, Health system constraints representing financial barriers, limited access to INR testing, workload, travel difficulties, and resource limitations reduced opportunities for both clinicians and patients. Although clinicians remained motivated to provide high-quality care, systemic constraints often limited their ability to achieve recommended standards. Theme 5,Integrated and Patient Centered Care was depicted througha demand for interventions like dedicated anticoagulation clinics, structured education, multidisciplinary collaboration, digital communication, and standardised protocols. These could improve knowledge, facilitate access to services, strengthen collaborative care, and encourage sustained engagement among clinicians and patients.
Table 2:Conceptual Categories
|
Category |
Description |
Representative Codes |
|
1. Clinical decision-making |
Factors influencing initiation and selection of anticoagulants |
Patient age, valve type, prosthetic graft, CHA2DS2-VASc, bleeding risk, thrombosis risk, comorbidities |
|
2. Therapeutic balancing |
Maintaining equilibrium between bleeding and thrombosis |
Target INR, dose titration, therapeutic window, over-anticoagulation, under-anticoagulation |
|
3. Risk |
Clinical outcomes failures |
GI bleeding, stroke, prosthetic valve thrombosis, embolic complications |
|
4. Patient capability |
Patient’s ability to understand and continue lifelong treatment |
Patient willingness, health literacy, psychological readiness, lifelong commitment |
|
5. Non-Adherence |
Adherence barriers |
Missed doses, problems with follow-up, forgetfulness, monitoring issues |
|
6. Shared responsibility |
Anticoagulation as a collaborative process |
Treating surgeon, patient responsibility, caregiver participation, shared decision-making |
|
7. Monitoring systems |
Monitoring practices used to optimise therapy |
PT-INR testing, dose modification, frequent monitoring, laboratory follow-up |
|
8. Communication and counselling |
Information exchange before and after surgery |
Pre-operative counselling, discharge counselling, explaining risks, repeated reinforcement |
|
9.Guideline-directed practice |
Use of evidence-basedprotocols |
American Heart Association /American College of Cardiology (AHA/ACC)/European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) Guidelines for the Management of Valvular Heart Disease,institutional policy |
|
10. Economic and logistical barriers |
Financial and practical barriers affecting treatment |
Cost of medicines, cost of INR testing, travel, loss of employment |
|
11. Institutional support systems |
Existingdepartmental mechanisms supporting anticoagulation |
Duty mobile, institutional protocol, OutpatientDepartment follow-up |
|
12. Multidisciplinary collaboration |
Inter professional involvement |
Cardiology, dieticians, physiotherapist, multidisciplinary rounds |
|
13. Organisational improvement |
Suggested reforms for anticoagulation services |
Warfarin clinic, valve clinic, dedicated personnel, patient education programmes |
|
14. Technologyenabledcare |
Communication outside hospital visits |
Telephone consultation, mobile follow-up, digital reminders, educational videos |
This phenomenological study explored the perceptions of treating doctors regarding facilitators and barriers to anticoagulant use in patients undergoing valve replacement surgery. Five interconnected themesemerged which demonstrated that anticoagulant management is a dynamic process requiring continuous clinical judgement, patient participation, and organisational support. 3* Participants consistently described maintaining anticoagulation as a challenge, weighing the risks and benefits. The 2020 American College of Cardiology/American Heart Association (ACC/AHA) and the 2021 European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines, which emphasise individualised anticoagulant therapy based on prosthetic valve type, thromboembolic risk, bleeding risk, and target INR.4,5An international survey of doctors who manage anticoagulation in those with mechanical heart valves recommended individualised decision making as there is high inter-individual variability.12 Lifelong anticoagulation emerged as the second theme which emphasizes the need for informed and engaged patients. Patient education, adherence,readiness, and family support are fundamentals to maintaining therapeutic anticoagulation. For shared decision-making, the patients needproper communication and support from the clinicians. Studies exploring the patient perspectives have reported communication barriers which included the indication of the drug resulting in conflicting expectations.11The patients reported passive roles in decision-making and usually agreed to the recommendations by the doctor about initiation of the drug.13However, the participants felt that there wasalignment of the recommendations with patient’s health goals taking care of the risk factors. Ehasni et al., found that the knowledge of nurses in the cardiovascular wards about warfarin was not sufficient, and their practice was of poor quality which could jeopardize their care. 14Proper training of nursing students and nurses about warfarin as a high‐risk drug, its side effects, and drug‐food interactions, and the emphasis on patient education in patients receiving this medicine can effectively reduce the incidence of side effects.Alkherat et al., found that participants had moderate knowledge and specialized training ought to be devised for pharmacists toimprove therapeutic outcomes with warfarin use.15 Studies have demonstrated that patients who had family support had greater adherence, however there needs to be more improvement in knowledge, adherence and satisfaction with warfarin therapy.16These findings are in line with this study pointing that health care providers should engage in patient education and shared decision making. The third themeputs forward the central role of regular INR monitoring, dose adjustment, and continuous communication between clinicians and patients. Adhikari et al., found low awareness,limited human resources, lack of dedicated policy, challenges in monitoring the lab parameters in warfarin users as the main barriers in a study on use of direct anticoagulants.10Participants described follow-up through private telephone consultations and dose titrations regularly even during their non duty hours despite the availability of services on duty mobile. Communication failures between healthcare providers and patients can contributeto suboptimal anticoagulation management.In tertiary cardiac centres, availability of doctors for continuity of care and clear communication on dos and don’ts are core areas to be strengthened for optimizing anticoagulant therapy. The fourth theme identified as health-system constraints which included need for multidisciplinary care and increased workload are barriers that are addressed at the organisational levels. Xuereb et al., pointed out that apart from exploring the issue of dichotomy of opinionon decision-making, the need for education and outcomes of workload pressure and need for education needs to betargeted for maintaining best practices in anticoagulation.17 This is particularly relevant in the context of a busy government teaching hospital where resources and services needs to be balanced. Integrated and patient-centred care was the fifth theme. Participants mentioned that dedicated anticoagulation or valve clinics with structured modules for education can improve the quality of care. A study conducted in the US on patient self-management on warfarin therapy, stated that education and implementation strategies are important to overcome the barriers in patient self-management.18 Linking these findings to the CapabilityOpportunityMotivation- Behaviour (COM-B) framework suggestsall stakeholders need to have an active role for sustainedanticoagulation.. The strengths of this study include the evidence from directparticipant descriptions rather than external assumptions. There is consistency of themes across participants supporting the credibility of the analysis. The limitation of this study is the single centre lived experiences of the doctors in a government setting which could affect the generalizability
The findings of this study suggest that anticoagulant management is a shared responsibility not only between the clinicians but also the patients and the healthcare system. There needs to be structured education in dedicated valve clinics with shared decision making and communication by health care professionals protecting the personal time of the doctors. More multicentric studies need to be done to explore the stakeholder perspectives including other health care professionals and administrators .The evidence on digital apps and artificial intelligence integrated with human in loop for dose titration should be generated .
Financial support and sponsorship : Authors would like to acknowledge the State Board of Medical Research, Government of Kerala for funding this project
Conflicts of interest There are no conflicts of interest.