|Year : 2021 | Volume
| Issue : 2 | Page : 114-117
Impact of COVID 19 lockdown on post operative follow up of patients with valvular heart disease: An international normalized ratio monitoring in a tertiary health care centre
Navneet Kumar Srivastva1, Dharmendra Kumar Srivastava1, Subhash Singh Rajput1, Bhuwan C Tiwari2
1 Department of Cardiothoracic and Vascular Surgery, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
2 Department of Cardiology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
|Date of Submission||20-Apr-2021|
|Date of Decision||26-Apr-2021|
|Date of Acceptance||15-May-2021|
|Date of Web Publication||25-Aug-2021|
Dr. Navneet Kumar Srivastva
Department of Cardiothoracic and Vascular Surgery, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Context: In this COVID-19 pandemic, most of the healthcare infrastructure including healthcare officials has now been allocated toward COVID management. It is not even feasible for regular patients to visit hospital as they are susceptible to get infected.
Aim: The aim is to study the impact of COVID-19 lockdown on the postoperative follow-up of patients with valvular heart diseases by international normalized ratio monitoring in a tertiary health care center.
Subjects and Methods: This is an observational study on patients with prosthetic valve conducted at a tertiary healthcare center. Sixty postoperative patients were surveyed with a prevalidated questionnaire designed for them. The questionnaire included questions about the availability of testing centers, communication facility with doctors, and a list of complications such as skin color change, nose bleeds, abdominal fullness, dyspnea, fever, numbness, swelling of limbs, and headache.
Results: The study comprised 60 patients with valve replacement surgery. 80% of patients faced difficulty in reaching the hospital during the lockdown; however, almost 86% of patients had telephonic conversation with the doctor. Almost 73% of patients did not have the testing facility in their locality. 34% of patients mentioned that they had history of prolonged fever, 14% presented with history of fullness of abdomen, 10% presented with episode of headache and unconsciousness, and 9% noticed a change in skin color.
Conclusions: COVID-19 is still on rise, and there is a long way before herd immunity is developed or everyone is vaccinated. We need to find alternatives so that patient care is not affected. Point-of-care testing should be encouraged as it will reduce hospital visits and exposure to hospital-acquired infections.
Keywords: COVID-19, point of care, prothrombin time/international normalized ratio, questionnaire, valvular heart disease
|How to cite this article:|
Srivastva NK, Srivastava DK, Rajput SS, Tiwari BC. Impact of COVID 19 lockdown on post operative follow up of patients with valvular heart disease: An international normalized ratio monitoring in a tertiary health care centre. Heart India 2021;9:114-7
|How to cite this URL:|
Srivastva NK, Srivastava DK, Rajput SS, Tiwari BC. Impact of COVID 19 lockdown on post operative follow up of patients with valvular heart disease: An international normalized ratio monitoring in a tertiary health care centre. Heart India [serial online] 2021 [cited 2021 Oct 27];9:114-7. Available from: https://www.heartindia.net/text.asp?2021/9/2/114/324612
| Introduction|| |
Valvular heart disease (VHD) is one of the leading causes of cardiovascular mortality and morbidity, with a prevalence rate of 2.5% in developed countries. Rheumatic heart disease (RHD, 63.4%) is the most frequently encountered VHD. In India, load of RHD as per hospital data is 20%–50%, followed by population-based studies (2.2%–1.6%) and school surveys (0.67%–4.54%). Mitral valve is the most frequently damaged valve (54.4%) followed by aortic (17.8%), tricuspid (9.7%), and pulmonary (0.04%).
Surgical valve repair or valve replacement (mechanical/bioprosthetic) has been the mainstay for treatment for decades, but the best outcomes are achieved on long-term regular follow-up. Anticoagulant therapy is critical in the first 3 months of surgery due to increased risk of thromboembolism. Mechanical valve replacement is at a higher risk of thromboembolic events. Atrial fibrillation is very common in patients with Mitral valve replacement (MVR) and thus requires anticoagulant therapy. Regular monitoring of international normalized ratio (INR) is a critical step in reducing morbidity in VHD. The most common test used to monitor anticoagulation therapy is the prothrombin time (PT). This is expressed as INR. The therapeutic range value is a good overall measure of the quality of antithrombotic treatment with Vitamin K (VKAs) antagonists in patients with VHD. Recommendations for INR testing have been presented in the flowchart [Figure 1]. The sub therapeutic target INR increases the risk of thromboembolic events, on the other side, INR above the therapeutic range increases risk of bleeding. INR monitoring helps to avoid over coagulation and guides decisions about the appropriate dosage regimen.
In anticoagulant overdose, major complication is bleeding in the form of gum/nasal bleeds, menorrhagia, hematomas, and sometimes intracranial bleed. Incidence of these bleeding complications varies from 0.34% to 1.32% per patient in a year. Infective endocarditis (IE) is another leading complication; hence, patients should be closely monitored if they develop fever. Cardiac failure and atrial fibrillation are other complications. Lower limb swelling, weakness, headache, and dyspnea on exertion should be well documented in every follow-up.
Data from clinical trials show that, even in a controlled environment with adequate monitoring follow-ups and dedicated nurses, the time in therapeutic range (TTR) values achieved was only 55%–64%., In addition, a large retrospective cohort study of over 50,000 patients with atrial fibrillation receiving warfarin showed that only 40,570 patients had sufficient INR results to assess TTR, and less than half (41%) of these patients had a TTR ≥65%. As such, providing adequate monitoring of warfarin amid the worsening COVID-19 pandemic, where social distancing is increasingly emphasized, is an unprecedented challenge faced by anticoagulant service providers around the globe.
COVID-19 has now become a household name, with over 12,149,335 cases detected as of March 30, 2021. Studies have shown that people with heart disease are at a greater risk of infection. Even though there are no data to prove that VHD increases the risk, such patients are prone to bleeding complication in the absence of proper follow-up. This pandemic has brought a halt in life of all. Routine healthcare has suffered a lot as most of the staff have been diverted toward COVID management. We have analyzed the impact of COVID-19 lockdown on the monitoring of INR in VHD patients. This study has been taken up with the intention to come up with options for a streamlined follow-up of patients during pandemics.
| Subjects and Methods|| |
This is an observational study conducted at a tertiary healthcare center. All patients with prosthetic valve (mitral, aortic, or both valve replacement) were included in the study. Patients with contraindication to anticoagulant therapy were excluded. Patients were counseled about the protocol of INR monitoring as per the recommendations by Saksena et al.
It is recommended that during the initiation phase, INR should be monitored every 2–4 days, until INR is in the TTR for two consecutive values. Once stabilized, INR should be monitored weekly. The interval can be gradually increased up to every 4–6 weeks if the INR remains stable and within TR. Dosage adjustment is not required for minor fluctuations of INR as long as the results remain within the patient's target range. Sixty postoperative patients were surveyed with a prevalidated questionnaire designed for them. The questionnaire was circulated among the patients through WhatsApp chat or in the outpatient department. The following questionnaire included questions about the availability of testing centers, communication facility with doctors, and a list of complications such as skin color change, nose bleeds, abdominal fullness, dyspnea, fever, numbness, swelling of limbs, and headache. The questionnaire was designed keeping in view the complications of deranged INR and COVID-19 scenario [Figure 2].
| Results|| |
The study comprised 60 patients with valve replacement surgery. 64% (n = 38) of patients had undergone mitral valve replacement, 14% (n = 8) with aortic valve replacement, and 22% (n = 14) with double valve replacement. 64% were female and 36% were male. 80% of patients faced difficulty in reaching the hospital during the lockdown; however, almost 86% had telephonic conversation with the doctor. Only 27% of patients had proper facility for PT/INR testing in their locality. Almost 73% of patients did not have the testing facility in their locality and thus continued with the already prescribed dose of medicine. 15% of them had even discontinued the medicine. 34% of patients mentioned that they had a history of prolonged fever, 14% presented with a history of fullness of abdomen, 10% presented with episode of headache and unconsciousness, and 9% noticed a change in skin color. The less common complaints observed were 8% lower limb swelling, 7% presented with nose bleed/gum bleed, 2% presented with dyspnea on exertion, and 1% presented with new-onset limb weakness and paresis. None of the patients presented with sudden loss of vision.
| Discussion|| |
In our study, more than half (73%) of the patients did not have proper facility for PT/INR testing. This is very alarming data in a country like India where every second person with VHD suffers from RHD. In this era of COVID-19 where social distancing is important, the practice of patient self-management of anticoagulation with patient self-monitoring using point-of-care (POC) devices is recommended. A single drop of blood from finger prick is put onto a test strip. Lucas et al. for the first time introduced whole-blood capillary technique for measuring the PT. Coaguchek and ProTime 3 are the most commonly used POC devices. In a comparison study by McBane et al., it was found that correlation with plasma was higher for the Coaguchek (r2 = 0.90) than ProTime 3 device. POC usually costs around 5000–10,000 rupees along with an additional cost of the strip. This is higher when compared to laboratory tests which cost around 35–45 rupees. However, they are cost-effective as they reduce the frequency of hospital visits. POC is the need of hour in India where laboratory testing is usually available in urban areas. Cochrane database systematic review (28 randomized controlled trials) has reported that patients can improve the quality of life with self-monitoring and management. Another important highlight is communication facilities with the doctor. 86% of patients were able to converse with the doctor on the phone and adjust the dose as per the change in INR. This COVID pandemic has also put in light the importance of medical ethics – proper and prompt response in this digitalized era can help in proper management. 15% of patients had discontinued the medicine even after proper counseling at the time of discharge. Hence, it is very important to talk to patients and make them aware of the complications as much as possible.
IE accounts for 10%–30% morbidity in postoperative VHD. Fever is the presenting complaint. In our study, 34% had complaints of fever; however, this percentage may not be a true representation of IE. During COVID times, patients are most sensitive about fever, and hence, even a mild fever was a matter of concern. Bleeding due to deranged INR accounts for 10%–17% per year for all events, 2%–5% per year for major bleeding, and 0.5%–1% per year for fatal bleeding. Intracranial hemorrhage, which is the most fatal complication, accounts for 0.2%–0.4% per year. In our study, 7% presented with nose/gum bleed. These patients had an above TTR INR. However, they took timely advice with no fatality. Six patients (10%) presented with episode of headache and unconsciousness. They had INR below the therapeutic range and had presented to the emergency. Two out of these six patients had paralysis of the lower limb. Such morbidity could have been easily prevented by simple regular INR testing. Heart valve prosthesis often predisposes patients to congestive heart failure (CHF). In our study, nine patients (14%) presented with abdominal fullness which is often a presenting feature of CHF. On further evaluation, six out of these nine patients also had pedal edema, and echocardiography showed features of CHF. Four patients presented with complaints of dyspnea on exertion, two out of them were positive for COVID-19 and managed as per protocol.
| Conclusions|| |
COVID-19 is still on rise, and there is a long way before herd immunity is developed or everyone is vaccinated. Till then, routine healthcare services will remain hampered. We need to find alternatives, so that patient care is not affected. PT/INR testing facilities should be made available even in rural/semiurban areas. POC testing should be encouraged as it will reduce hospital visits and exposure to hospital-acquired infections. However, POC will be a success only if the patient is well counseled at the time of discharge. Patient self-management on anticoagulation is the need of the hour. Healthcare infrastructure should include facilities for telemedicine so that patients are in touch with doctors and can discuss their follow-up. A simple regular testing of PT/INR can prevent long-term mortality and morbidity.
Navneet Kumar Srivastva and Dharmendra Kumar Srivastava contribute to draft the manuscript, Navneet Kumar Srivastva Subhash Rajput, Bhuwan Chandra Tiwari revised it critically for important intellectual content and gave the final approval of the version to be submitted. All the authors reviewed and contributed the final version.
All procedures involved in the study have been done in accordance with the ethics committee of the institution. IEC 76/20.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Iung B, Vahanian A. Epidemiology of acquired valvular heart disease. Can J Cardiol 2014;30:962-70.
Manjunath C, Srinivas P, Ravindranath K, Dhanalakshmi C. Incidence and patterns of valvular heart disease in a tertiary care high-volume cardiac centre: A single centre experience. Indian Heart J 2014;66:320-6.
Kumar RK, Tandon R. Rheumatic fever and rheumatic heart disease: The last 50 years. Indian J Med Res 2013;137:643-58.
] [Full text]
Kim YK, Nieuwlaat R, Connolly SJ, Schulman S, Meijer K, Raju N, et al.
Effect of a simple two-step warfarin dosing algorithm on anticoagulant control as measured by time in therapeutic range: A pilot study. J Thromb Haemost 2010;8:101-6.
Panduranga P, Al-Mukhaini M, Al-Muslahi M, Haque MA, Shehab A. Management dilemmas in patients with mechanical heart valves and warfarin-induced major bleeding. World J Cardiol 2012;4:54-9.
Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al.
Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51.
Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al.
Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883-91.
McAlister FA, Wiebe N, Hemmelgarn BR. Time in therapeutic range and stability over time for warfarin users in clinical practice: A retrospective cohort study using linked routinely collected health data in Alberta, Canada. BMJ Open 2018;8:e016980.
World Health Organization. Coronavirus Disease (COVID-19) Weekly Epidemiological Update and Weekly Operational Update. Geneva, Switzerland: World Health Organization COVID-19 weekly epidemiological update, 2020.
Saksena D, Mishra YK, Muralidharan S, Kanhere V, Srivastava P, Srivastava CP, et al.
Follow-up and management of valvular heart disease patients with prosthetic valve: A clinical practice guideline for Indian scenario. Indian J Thorac Cardiovasc Surg 2019;35:3-44.
Lucas FV, Duncan A, Jay R, Coleman R, Craft P, Chan B, et al
. A novel whole blood capillary technic for measuring the prothrombin time. Am J Clin Pathol 1987;88:442-6.
McBane RD 2nd
, Felty CL, Hartgers ML, Chaudhry R, Beyer LK, Santrach PJ. Importance of device evaluation for point-of-care prothrombin time international normalized ratio testing programs. Mayo Clin Proc 2005;80:181-6.
Lakshmy R, Kumar AS. Comparative evaluation of point of care coagulation monitoring by Coaguchek XS-comparison with standard laboratory method. Indian J Thorac Cardiovasc Surg 2010;26:125-8.
Heneghan CJ, Garcia-Alamino JM, Spencer EA, Ward AM, Perera R, Bankhead C, et al.
Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst Rev 2016;7:CD003839.
Pettersson GB, Hussain ST. Surgical treatment of aortic valve endocarditis. In: Cohn LH, Adams DH, editors. Cardiac Surgery in the Adult. 5th
ed. New York: McGraw Hill Education; 2018. p. 731-41.
Stehle S, Kirchheiner J, Lazar A, Fuhr U. Pharmacogenetics of oral anticoagulants: A basis for dose individualization. Clin Pharmacokinet 2008;47:565-94.
Palareti G, Cosmi B. Bleeding with anticoagulation therapy - Who is at risk, and how best to identify such patients. Thromb Haemost 2009;102:268-78.
Butany J, Ahluwalia MS, Munroe C, Fayet C, Ahn C, Blit P, et al.
Mechanical heart valve prostheses: Identification and evaluation (erratum). Cardiovasc Pathol 2003;12:322-44.
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