Middle-aged man who could not afford an angioplasty

Abstract

Coronary artery disease managed by percutaneous coronary intervention (PCI) has been noted for profit-driven overuse medicine. Concerns mount over inappropriate use of PCI for patients in India. We describe the case of a 55-year-old Indian man who presented for a second opinion following an urgent recommendation for PCI by two cardiologists following a recent acute myocardial infarction even though the patient was symptom-free and out of the window period for primary PCI. The proposed intervention placed the patient at financial risk for insolvency. This case report highlights the challenges and consequences of inappropriate overuse of PCI. Also, we outline the current lack of shared decision-making among patients and physicians for the PCI procedure. The challenges, inherent in the assumptions that overuse of PCI is evidence-based, are discussed including recommendations for the practice of evidence based medicine for this intervention.

Case presentation

A 55-year-old man developed sudden severe right-sided chest pain at 01:00 during the summer of 2017. The patient, believing the pain was related to gas ingested acid reducing agent. After 12 hours he was admitted to a local hospital, 100 km away from our institution. His history was significant for medically treated type-2 diabetes mellitus (glipizide-metformin) of 6 years and hypertension (amlodipine 5 mg) of 10 years duration. Clinical cardiac examination findings were normal.

After admission, an electrocardiogram (ECG) performed at 14:00, (figure 1) revealed significant ST-segment elevation in chest leads (V1–4), suggestive of an acute anterior wall myocardial infarction (MI).

Figure 1.

ECG at presentation showing significant ST-segment elevation in the chest leads V1–4.

An echocardiography, showed moderate dysfunction in the heart during diastole and absence of movement in some of the walls of the heart named anatomically as anteroseptal-apical, basal and midanterior portions of the left ventricular wall. The left ventricular systolic contractility measured in terms of the left ventricle ejection fraction was 40%. A chest radiograph posteroanterior view showed normal findings. Laboratory results showed creatine phosphokinase (CPK) 743 U/L (reference range, 52–336 U/L), creatinine kinase-MB isoenzyme (CK-MB) 33.8 U/L (reference range,<24 U/L), lactate dehydrogenase (LDH) 582 U/L (reference range,<248 U/L).

A second ECG performed at 20:00 the same day revealed QS pattern in chest leads (V1–4) suggesting that the previous MI was evolving with time (figure 2). Thrombolysis intervention was not done perhaps because the patient presented after the ‘window period’. Coronary angiography was planned 19 hours after initial chest pain. The coronary angiography revealed 30% stenosis to the proximal and midpart of the left main coronary artery, and 95% stenosis to the left anterior descending artery (LAD) indicative of a single vessel disease (SVD). The cardiology team advised the patient that percutaneous coronary intervention (PCI) with drug-eluting stent to LAD was urgently needed. Although the patient reported he was unable to afford the angioplasty, the cardiology team remained insistent on angioplasty without pausing to share alternative options. As the patient reported being unable to afford PCI, he was discharged on medical therapy. The patient left the hospital with fear and without confidence in the medications, although his chest pain had subsided well by 2 days. When the patient was taken to another cardiology team, they reiterated the same advice even though the patient was asymptomatic.

Figure 2.

ECG 6 hours after initial presentation showing QS pattern in the chest leads V1–4.

The man’s son, disturbed by the previous cardiology team’s approach to care, brought his father to us at this time after 3 days for an additional opinion to our department of medicine, IQ City Medical College and Hospital, Durgapur, India. On evaluation by the internist team, the patient did not have the objective clinical features of congestive cardiac failure. Given the clinical condition of the patient, the internist team discussed the evidence for different therapeutic options other than angioplasty with the patient and family members and proposed a plan of care. The patient was spared financial hardship and questionable coronary intervention. In the absence of stent-based intervention, the patient continues to do well with good tolerance of his day to day ordinary physical activity under simple medical management including antiplatelet agents and statins, nearly 2 years after his initial presentation described above.

Global health problem list

• Overuse of coronary stent intervention without high quality evidence.

• Lack of shared decision making (SDM) for appropriate coronary interventions.

• Misconceptions about intervention efficacy among both physicians and patients.

• Overuse of PCI procedures and the relationship to the financial burden for patients.

Global health problem analysis

Overuse of coronary stent intervention without high quality evidence

The present patient was advised to undergo PCI after 19 hours’ of initial symptom onset even though he was asymptomatic and haemodynamically stable. As per treatment and outcomes of acute coronary syndromes in India (CREATE) registry data, 31% of the ST-elevation myocardial infarction (STEMI) patients presented after 12 hours of the onset of chest pain.¹ The 2013 American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines for the management of STEMI consider primary PCI as a class I indication in STEMI patients within 12 hours’ of initial symptom onset.² Beyond this timeframe PCI does not show benefit, as shown in the occluded artery trial which evaluated PCI benefit among stable, high-risk patients with persistent total coronary occlusion after MI. The study concluded that PCI performed from 3 to 28 days after MI does not decrease the incidence of death, reinfarction or New York Heart Association (NYHA) class IV heart failure but it is associated with higher rates of both procedure-related and true ST elevation reinfarction.³ A retrospective analysis of the clinical data revealed The Thrombolysis in Myocardial Infarction (TIMI) Risk Score of 4 predicting a 30-day mortality of 7.3% in this patient. Late PCI leads to the increased risks of periprocedural complications, long-term bleeding, and stent thrombosis.⁴

PCI is a life-saving intervention validated for MI and angina relief in stable coronary artery disease (CAD). It has a survival benefit for patients with acute myocardial infarction (AMI) and can reduce morbidity and improve quality of life if performed within 12 hours of MI. However, PCI has not been shown to reduce incidence and recurrence of heart attack or death in stable CAD. PCI is a viable option only if symptoms persist despite appropriate medical therapy or with imaging confirmation of high ischaemia burden on the left ventricle.⁵

There is a blossoming CAD industry due to increasing demand for coronary stents in India, which has the world’s highest mortality rate from CAD among developing nations.⁶

India and China are two emerging markets for interventional cardiology according to National Intervention Council of the Cardiological Society of India. The total volume of cardiovascular interventions is estimated to increase worldwide from 2016 to 2022 by an average of 3.7% per year.⁷ The projected increase is one rationale for the standardisation of a system for clinical audit of the procedure in India.

The high incidence of CAD and the increasing need for PCI provides an opportunity to evaluate its appropriate use and highlight potential overuse. PCI is frequently reported to be overused and inappropriately recommended. Behnke et al defined overuse as ‘use of unnecessary care when alternatives may produce similar outcomes, resulting in a higher cost without increased value’.⁸ Overuse causes a heavy financial burden on people living in countries, where fee-for-service and ill-regulated private healthcare provides much of the patient care. As a result, cost of healthcare increases and causes potential harm to the patients.

In India, concerns mount over inappropriate PCI use for patients who are unlikely to benefit. Brownlee et al reported that in an Indian second opinion centre, over 50% of recommended PCI was unnecessary.⁹ Another study reports that in a tertiary healthcare centre, approximately 55% of all elective PCI were inappropriately performed among patients who suffered STEMI with total occlusion in the infarct-related artery following symptom onset after 12 hours. The balance of the inappropriate elective PCI (45%) constituted patients of stable angina with single (SVD) or double vessel disease (DVD), low-risk groups and suboptimal antianginal therapy.⁴ Brownlee et al investigated the evidence for the global overuse of medical services and found the prevalence of inappropriate PCI procedures in Israel (22%), Spain (20%), Italy (16%), Germany (14%), USA (12%) and Korea (4%). The study also found that in the USA, PCI performed on 38% of asymptomatic and haemodynamically stable STEMI patients with SVD or DVD who presented within 12 hours’ of symptom onset was not appropriate.⁹ Zhang et al found coronary stenosis to be overestimated in 10% and 16% of patients with AMI and without AMI leading to unnecessary intervention due to physician visual assessment errors.¹⁰ Provider and patient both play a role in the overuse of PCI but the clinician has the greater knowledge and therefore the primary responsibility for assuring appropriate and resource sensitive care. Multiple factors have been found to be responsible for the PCI overuse. Box 1

Box 1. Factors responsible for percutaneous coronary intervention (PCI) overuse^{5 8} .

Provider-related factors

• Inappropriate PCI recommendation without coronary artery bypass grafting (CABG) facility availability.

• PCI and diagnostic catheterisation performed during the same session (ad hoc PCI).

• Lack of shared decision making.

• Medico-legal concerns related to risks from failed medical intervention.

• Poorly regulated, privatisation and fee-for-service in healthcare.

• Fear of missing the ‘widow-maker’.

Patient related factors

• Patient preference for minimally invasive PCI over CABG.

• Lack of health literacy among patients.

• Fear, anxiety, misperceptions and misbeliefs among patients about PCI benefits over optimal medical therapy and lifestyle modification.

Lack of SDM for appropriate coronary interventions

SDM has been a part of person-centred care over the past three decades and is progressively gaining global interest especially in healthcare policy. This requires providing patients with high-quality health information to support their decision-making process, which ensures patients have adequate knowledge and understanding about their own health helping them play an active role concerning their healthcare decisions. Deber shares that ‘making decisions about one’s health consist of ‘problem-solving’ and ‘decision-making’ that requires the contribution of patients' values and preferences’.^{11 12} Braddock et al have defined seven elements of informed decision making and studied these with how physicians are addressing these in their clinical practice with patients and found that only 3% of the discussion contained all these elements.¹³ Despite improved patient outcome associated with adequate health information, several studies report patient dissatisfaction due to inadequate information being provided.¹² Studies with patient reported outcomes report improvement of care and reduced costs with SDM.¹⁴ Patients are also more likely to follow the plan of care and choose more conservative care from the position of knowledge and confidence. A study reported that one-fifth of the patients preferred minimally invasive surgeries and more conservative care when they were actively involved in the SDM. A decade ago Lewin Group had reported that implementing SDM process in the eleven procedures could reduce the cost of US$9 billion in 10 years’ time.¹⁵

Misconceptions about true efficacy of the intervention among both physicians and patients

There is a popular misconception among patients with stable angina that PCI can reduce the risk of heart attacks and cardiovascular mortality despite the contrary evidence, as reflected in a study where over 85% of patients overestimated the benefits of PCI, believing that it will reduce their chance of heart attacks. In contrast, when cardiologists were interviewed, 45% of them overestimated the PCI benefits, believing that it will reduce mortality and prevent heart attacks.¹⁶ The appropriateness of coronary interventions in MI and its misinterpretation is demonstrated through an Indian case report in a global social media platform called Quora. In this report, Tiny Nair, a cardiologist, reports that a middle-aged man with stable angina and 95% stenosis in the right coronary artery (RCA) was referred for PCI. Despite the patient’s reluctance cardiologists repeatedly claimed that “you are taking unnecessary risk of ending up in a major heart attack any-time, and don’t unnecessarily delay; you are sitting on a time bomb”. Two years later when he developed MI, angiography revealed a complete new stenosis to the left coronary artery, while his RCA still had the same stenosis.¹⁷ A singular case example of a social media anecdote may not be generalised as it is contrary to the basics of evidence-based medicine; however, this story conveys the important message that most often acute coronary syndrome (ACS) happens due to a rupture of thin plaques that is not always seen in angiography, as was the case with the left coronary plaque in Nair’s example which remained invisible and unstentable even as his doctors recommended an unnecessary stent in the right artery. Chronic stable plaques often contain a thick fibrous cap that is less likely to rupture suddenly or cause ACS even with angiographically significant stenosis. They are more likely to cause chronic stable angina although they are an accepted indication for PCI, in terms of convenience and pain relief rather than for survival benefit.^{18 19}

PCI has associated risks along with cost implications, indicating the need for actively involving patients in the decision-making process, so they can choose the best treatment option that aligns with their resources, goals and preferences.²⁰

In-depth retrospective review of our current case and after searching all the available evidence it was apparent that coronary stenting in this patient was not necessary. The discussion with the patient about the evidence concerning stenting and survival benefit offered hope to this patient who expressed concerns about the hardships the cost of this surgery would place on his family. The patient was relieved to find a reasonable and safe alternative to stenting after being informed by two cardiologists about the necessity of coronary stenting following the MI.

Grand view research Inc. reports coronary stenting is predicted to rise globally to US$15.2 billion by 2024.²¹ Overuse of these coronary interventions when appropriate alternatives can provide similar outcomes or potentially better outcomes contributes to the excessive healthcare expenditure.⁴ In the USA alone, unnecessary use of coronary stents cost US$2.4 billion per year to the healthcare system.²² When a patient has limited health literacy, they can be vulnerable to inappropriate reassurance that PCI is superior to optimal medical therapy in reducing mortality and risk of major cardiac events. A study showed that 71%–88% of patients even with little or no angina believe that PCI can reduce the risk of death.¹⁶ When patients are actively engaged in the evidence-based SDM they can understand the rationality of treatment choices. SDM can provide an opportunity for multidisciplinary input and meaningful discussion of risks and potential benefits of treatment options with the patient. SDM reduce the tendency to overestimate the benefits of these procedures among both physicians and patients and can positively influence the cost of care and clinical outcomes.

Overuse of PCI procedures and the relationship to the financial burden for patients

A large part of the world’s population has no access to primary healthcare. Today excessive health expenditure is pushing people around the world into poverty. Currently, over 800 million of the world’s population spend one-tenth of the household budgets on health, and approximately 100 million people are in extreme poverty because of out-of-pocket health expenditure (OOPE).²³

In India, less than one-third of the population has healthcare coverage and all others pay out of pocket for their health expenditure. Current healthcare in India is a major source of poverty and debt. With the current situation of health coverage and health expenditure in India, the patient and their family members are subjected to a large financial burden. It is estimated that approximately 69% of healthcare payments in India are made via household OOPE.²⁴ Prinja et al reported that 26% of the rural household in India depends on lending money from others and selling their properties for overall medical expenses.²⁵ Another study reported that in India, where our current patient is residing; around 40% of household OOPE for health expenses for non-communicable diseases are made by selling of properties and lending money.²⁶ Jason Overdorf reported regarding healthcare expenditure in India that ‘80% of costs are paid out-of-pocket and healthcare debts plunge 40 million Indians into poverty every year’.²⁷

Although this case report discusses a single patient in India we need to remember that these challenges are global and that successful medical care depends on meeting these challenges.

One proposed solution for the future is Universal Health Coverage which is a global health policy that ensures all people get quality health services, where and when they need them, without suffering financial hardship. This will, however, take time and resources to implement and in the interim clinicians and patients can work together to insist on accountability and informed healthcare choices.

For quality control and improvement of care, health policy planning and financing, continuous evaluation of patient care processes and outcomes are necessary against well-defined and established standards based on the principles of evidence-based medicine.²⁸ In India there is no system of clinical audit and the entire procedural mechanism is largely unregulated allowing non-evidence practice to flourish. This is the biggest barrier and a central nationwide clinical audit body is the need of the hour.²⁹

In a recent study, Podder et al demonstrated a potential solution to the current pandemic of overdiagnosis and overtreatment using a case-based blended learning ecosystem (CBBLE). In this learning ecosystem, a concerted team communication and collaborative learning between healthcare stakeholders provide evidence-based, patient-centred inputs across a web interface and this informational support increase the chances of accuracy and precision in terms of diagnosis and treatment facilitating the process of optimal patient-centred care.³⁰

In our current patient, to gather evidence-based solutions in terms of treatment accuracy, VP, one of the authors of this case report, uploaded this patient’s deidentified care record onto an online accessible database to enable sharing of his clinical details and potential queries with global experts in the user-driven healthcare network through Tabula Rasa,³⁰ the online social media platform of the CBBLE.

A concerted collaborative learning discussion between the global audience of medical students and multidisciplinary faculty members including cardiologists (accessible in this patient’s online record here³¹) provided evidence-based inputs around this patient, which strengthened our decision making for him.

Conclusion

Inappropriate use of PCI imposes physical, mental and financial hardship on the public. This effect endangers health systems by increasing healthcare costs and directing resources which could be used to cover the unmet health needs of the population.⁹ Every unnecessary procedure pushes the family toward the lower rungs of poverty and healthcare today in India is a common cause for this disease, called poverty. Informed SDM can build a bridge to advance better care and increased health literacy.

Patient’s perspective.

In 2007, there was a boil in my mouth, which was not healing. So, I went to a doctor. Some tests were done and it was found that I have diabetes. I was prescribed to take three tablets of Glymax-MF per day. In 2011, it was found that I also have hypertension and I was prescribed some blood pressure medicines. In 2017, near around 01:00 I felt pain on right side of my chest and I thought that it was a pain due to gas. So, I took an acid reducing drug. I went to a doctor due to this pain and doctor also thought that it was pain due to gas. So, he gave me a painkiller injection to my waist. When not improved that day, I was admitted to another hospital. On the next day, my reports were done and I was sent to a city hospital.

Learning points.

• Inappropriate use of percutaneous coronary intervention (PCI) imposes physical, mental and financial harm to patients.

• Shared decision making can reduce the tendency to overestimate the benefits of PCI among both physicians and patients and can positively influence the cost of care and clinical outcomes.

• PCI overuse can damage health systems by increasing healthcare costs and directing resources which could be used to cover the unmet health needs of the population.