Health Status and Quality of Life of Patients Enrolled in a Specialized Refractory Angina Clinic

Article Citation:

Noel M. Bennett, Stephanie Rutten-Ramos, Theresa L. Arndt, Ross F. Garberich, Jay H. Traverse, Anil K. Poulose, Patricia Mitchell, Katelyn M. Storey, and Timothy D. Henry (2018) Health Status and Quality of Life of Patients Enrolled in a Specialized Refractory Angina Clinic. Journal of the Minneapolis Heart Institute Foundation: Fall/Winter 2018, Vol. 2, No. 2, pp. 4-8.

Research Article

Noel M. Bennett, MD

Stephanie Rutten-Ramos

Theresa L. Arndt, RN

Ross F. Garberich, MS

Jay H. Traverse, MD

Anil K. Poulose, MD

Patricia Mitchell, RN

Katelyn M. Storey, BA

Timothy D. Henry, MD

Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, MN; Cedars-Sinai Heart Institute, Los Angeles, CA

Disclosures: Funding provided by Baxter.

The authors do not have any conflicts of interest with this manuscript.

Correspondence to: Timothy D. Henry, MD, Cedars-Sinai Heart Institute, 127 S San Vicente Boulevard #A3100, Los Angeles, California 90048, Tel: 424-315-2699, E-mail: henryt@cshs.org

ABSTRACT

As the mortality of coronary artery disease improves and the population ages, an increasing number of patients with refractory angina are not candidates for percutaneous or surgical revascularization. We evaluated the impact of a dedicated refractory angina clinic on quality of life. In 76 patients who completed the Medical Outcomes Study 36-Item Short-Form Health Survey and Seattle Angina Questionnaire at baseline and 1 year, the Medical Outcomes Study results showed the proportion of patients who rated their health as “good” or “excellent” more than doubled from baseline to 1 year (15.8% vs. 42.2%; P < .001). Similarly, the Seattle Angina Questionnaire score was significantly improved at 1 year compared to baseline (P = .025), as were angina stability (P = 0.017) and angina frequency (P = .010). In conclusion, treatment in a dedicated clinic is associated with improved quality of life in patients with refractory angina.

Keywords: quality of life, refractory angina

INTRODUCTION

As the mortality from coronary artery disease (CAD) improves and the population ages, an increasing number of patients continue to experience angina that is unresponsive to surgical or percutaneous coronary revascularization, despite optimal maximal medical therapy.1–5 These patients diagnosed with refractory angina (RA) are suboptimal candidates for revascularization due to complex coronary anatomy or significant comorbidities. Such patients are commonly referred to as “no option” patients. It is estimated that 8%–15% of patients undergoing cardiac catheterization in the United States are not suitable for complete revascularization.3–6 Historically, these patients have high mortality and morbidity.7 We recently reported that contemporary mortality has improved with advances in revascularization techniques, secondary prevention, and antiplatelet therapy.8 Therefore, the major challenge for these patients remains quality of life (QOL), but there are limited data regarding our ability to impact QOL in this challenging patient population as dedicated RA clinics are uncommon.

The OPtions In Myocardial Ischemic Syndrome Therapy (OPTIMIST) program at the Minneapolis Heart Institute, Abbott Northwestern Hospital, is a dedicated RA clinic that offers traditional and investigational therapies for “no option” patients.8 The aim of this study was to evaluate the impact of participation in a dedicated RA clinic on QOL. This was accomplished through the use of two validated QOL questionnaires given to RA patients at baseline and 1-year follow up: the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the Seattle Angina Questionnaire (SAQ).

METHODS

The weekly OPTIMIST Clinic is staffed by cardiologists, an interventional cardiology fellow, two clinical nurses, a clinical assistant, research nurse coordinators, and research assistants. Referral sources include patient self-referral, cardiologists both in and outside the Minneapolis Heart Institute cardiology practice, and primary care physicians within the Twin Cities area and in outstate Minnesota. Patients were predominantly referred from the upper Midwest region of the United States. Patients referred to the OPTIMIST Clinic have a thorough review of medical records and previous coronary angiograms to determine if the patient is on optimal medical therapy including secondary prevention and if further revascularization is an option.8

Patients referred to the clinic are enrolled in a comprehensive prospective database with detailed baseline and angiographic characteristics and annual follow up to monitor major adverse cardiovascular events (MACE, death, myocardial infarction, revascularization).8 It includes patients already on maximally tolerated medical therapy who were suboptimal candidates for further surgical or percutaneous revascularization options and were being evaluated for alternative therapeutic options, including novel pharmaceuticals (eg, ranolazine, L-Arginine), enhanced external counterpulsation (EECP), angiogenesis clinical trials (gene or stem cell therapy), spinal cord stimulation, and transmyocardial revascularization (TMR).

Over a 4-year span, patients from the OPTIMIST Clinic consented to and were enrolled in this substudy (Quality of Life in Patients with Refractory Angina, Identification No. NCT00840437). To enroll, patients agreed to complete the baseline questionnaires at initial visit, as well as questionnaires at a 12-month follow-up. A total of 89 consecutive patients were enrolled and completed the baseline questionnaire. At the 12-month follow-up, 5 patients had withdrawn, 5 patients were lost to follow-up, and 3 patients died, leaving 76 patients who completed both baseline and 12-month follow-up questionnaires.

Enrolled patients also completed the SF-36, a widely used survey to monitor health-related QOL measures used in the general population as well as patients suffering from CAD. Also completed was the SAQ, a CAD-specific instrument designed to assess health-related QOL for angina patients at the initial visit and again at the 12-month visit. The SF-36 questionnaire measures health-related QOL with eight subscales: Physical Functioning, Physical Role, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role, and Mental Health. Scores for each variable are summed and transformed into a Likert scale ranging from 0 (worst) to 100 (best). In a study assessing the SF-36 scores of the U.S. general population from 2005 to 2006, scores for each subscale reported a mean and standard deviation of approximately 50 ± 14.9 The SAQ is a 19-item self-administered questionnaire measuring health status in patients with CAD across 5 domains: physical limitation (PL), angina stability (AS), angina frequency (AF), treatment satisfaction (TS), and QOL. All domain scores range from 0 to 100, with higher scores indicating less angina, fewer physical limitations due to angina, and better QOL.10–11

Descriptive statistics are displayed as means and standard deviations for continuous variables; number and percentage with characteristic are given for categorical variables. Continuous variables were tested for normality. Normally distributed variables were compared using the Student t test. Non-normally distributed variables were compared using the Mann-Whitney U test. Chi-square analysis was used to evaluate categorical variables. All analyses were performed in SAS 9.3 (SAS Institute, Inc., Cary, North Carolina). Institutional Review Board approval was obtained for survey distribution, data collection, and data analysis.

RESULTS

There were 89 patients who enrolled in this study at baseline. The median age of these patients was 58 years old, and 78 (88%) were male. This cohort had a high prevalence of comorbidities and complex cardiovascular history but were well managed medically (Table 1). Overall, 74 (83%) of patients had a history of hypertension, 88 (99%) had a history of dyslipidemia, and 33 (37%) were diabetic. Cardiac history was complex as 69 (78%) had a prior percutaneous coronary intervention (PCI), 53 (60%) had a prior myocardial infarction (MI), and 62 (70%) had undergone prior coronary arterial bypass grafting (CABG). Baseline medications included 82 (92%) patients taking aspirin, 73 (82%) on a beta blocker, 81 (91%) on a statin or lipid lowering agent, 55 (62%) on an ACE-I or ARB, and 53 (60%) on an additional antiplatelet medication. At the time of enrollment, 22 (25%) of the patients were at CCS Angina Class 4, followed by 37 (42%) at CCS Angina Class 3, 15 (17%) at CCS Angina Class 2, and 5 (6%) at CCS Angina Class 1 (Table 1). The three most common reasons for patient referral to the RA clinic were for collateral dependent ischemia (61%; n = 54), a severely degenerate or occluded saphenous vein graft (40%; n = 36), or for diffuse disease (39%; n = 35).


TABLE 1
Baseline demographics and medications.

Over the course of 12 months, patients were treated with a variety of clinically available therapies (EECP, novel pharmaceuticals, CTO, TMR) or novel research protocols (gene or stem cell therapy). Of the 89 participants who completed the SF-36 and SAQ questionnaires at baseline, 76 completed the questionnaires at 1 year. At baseline, the “no option” patients were below the SF-36 population mean (50 ± 10 SD) in almost all categories, including both physical and mental health dimensions as well as the total score (Table 2).9 As expected, the “no option” patients had angina stability, angina frequency, and QOL scores below mean scores for a stable CAD population (Table 2).10,11


TABLE 2
Quantitative results of SF-36 and SAQ questionnaires.

The baseline and 1-year results for the SF-36 and SAQ (shown in Table 2) with both showing improved QOL for patients. Within the SF-36, increases from baseline to 1 year were seen in the Role Physical 25.7 ± 37.9 vs. 34.0 ± 39.1; P = .078), Role Emotional (35.0 ± 35.1 vs. 44.9 ±39.4; P = .099), Dimension: Mental Health (50.4 ± 19.2 vs. 53.9 ± 20.3; P = .034), and Total Score (47.5 ± 21.0 vs. 51.3 ± 21.7; P = .092). Similarly, the SAQ showed significant improvement from baseline to 1 year in patients’ functional status reported by AS (45.1 ± 23.8 vs. 54.6 ± 25.1; P = .017), AF (59.5 ± 29.0 vs. 71.4 ± 27.5; P = .010), and QOL (51.8 ± 27.3 vs. 61.3 ± 25.8; P = .025).

Additionally, SF-36 questionnaire responses from all participants results showed the proportion of patients who rated their health as “good” or “excellent” more than doubled from baseline to 1 year (15.8% vs. 42.2%; P = .001) (Figure 1). At the 1-year follow-up visit, the rate of major adverse cardiac events was low, including 3 (3.4%) patient deaths and 4 (4.5%) myocardial infarctions with no patients experiencing stroke (Figure 2). During the 1-year period, 26 patients had undergone novel treatment therapies, including 7 having EECP, 11 enrolled in an angiogenesis clinical trial, 2 receiving TMR, 4 receiving novel pharmaceuticals, and 2 patients receiving EECP and novel pharmaceuticals.


FIGURE 1
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) reported health status for subjects completing both baseline and 1-year follow-up questionnaires.
FIGURE 2
Proportion of patients with freedom from all-cause mortality or myocardial infraction at 1 year.

DISCUSSION

The OPTIMIST program provides patients with a wide range of approved and experimental therapies in a dedicated RA clinic. A long-term prospective database was created in this patient population to help understand the long-term prognosis, as well as factors that predict adverse outcomes. This current study presents objective and subjective measures of disease burden of RA (including functional capacity, symptom control, and QOL) for 76 patients who agreed to perform baseline and 1-year follow-up SF-36 and SAQ questionnaires. Despite historic reports of high mortality, the contemporary outcomes in this high-risk patient population have significantly improved.8,12 The 3.4% mortality at 1 year in our cohort is nearly identical to our recent report and lower than previously reported.8,12 In light of the improved mortality, therapeutic interventions should focus on improving QOL.3 Our survey results indicate significant improvements in emotional role, angina severity, and QOL at 1 year in patients enrolled in a dedicated RA clinic.

Users of the SF-36 survey have the advantage of interpreting and comparing their study results to the norm-based population SF-36 summary score of a mean of 50 and a standard deviation of 10 for all eight scales (T-score transformation used), as all measures have comparable means and standard deviations.9 At baseline, the Physical Dimension, Mental Dimension, and Total SF-36 scores in the OPTIMIST population were lower than the mean scores of the norm-based population summary scores but had increased at the 1-year follow-up. The improvement at 1 year in the Mental Dimension and Total SF-36 scores of the OPTIMIST population actually lead to higher mean scores than those in the norm-based population.9 This supports our hypothesis that QOL as measured by the SF-36 survey improved with treatment in the dedicated RA clinic.

The SAQ measures 5 specific dimensions of CAD, as well as a summary score. As expected, the baseline scores in the OPTIMIST population for Angina Stability, Angina Frequency, and QOL parameters of the SAQ were lower than the mean scores for a stable CAD population.10,11 However, similar to the findings of the SF-36 population data, the scores in the OPTIMIST population at 1-year follow-up were higher for these parameters compared to generalized stable CAD patient scores (Table 1).10,11 At baseline and 1-year follow-up, the scores in the OPTIMIST population for PL and TS parameters of the SAQ were higher than the baseline mean scores for a stable CAD population.14 This supports our hypothesis that Angina Stability, Angina Frequency, and QOL (as measured by the SAQ survey) actually improved beyond the average of a stable CAD population by a dedicated RA clinic. A smaller prior study done in 2004 in the UK assessed the impact of a dedicated RA clinic on health-related QOL for 69 patients who completed surveys at baseline and 1 year. The prior 2004 study also found that these consecutive patients experienced significant improvements in Angina Stability, Angina Frequency, Treatment Satisfaction, and QOL.13

Aggressive lifestyle modification (smoking cessation, diet modification, exercise) combined with improved adherence to maximal medical therapy (antiplatelets, angiotensin converting-enzyme inhibitors, and statins) contributes to improved mortality in CAD and RA patients. Mortality at 1 year was relatively low at 3.4%, consistent with the mortality rate lower than the 4% found in our recent study of the natural history of RA, despite the significant burden of angina and atherosclerosis.3

There are several limitations to this study. This registry is observational but does represent a diverse cohort of RA patients within the OPTIMIST program who are suboptimal candidates for revascularization. Referral bias is an inherent limitation. Determination of when a patient has exhausted traditional revascularization options can be difficult and subject to physician opinion.14 Patients often receive several novel therapies, including EECP, pharmaceutical therapy including ranolazine, and experimental therapies. Given the relatively small sample size, we did not attempt to correlate specific therapies to improved QOL scores. Additionally, selection bias may exist, given higher reported health scores of patients able to complete 1-year follow-up visits compared to patients who were lost to follow-up.

In conclusion, our results indicate that treatment in a designated RA clinic is associated with improved QOL at 1 year in a challenging group of patients with limited options. Further studies should be directed at correlating the success of specific therapies on improvement in QOL and angina symptoms so that resources can be efficiently and effectively utilized in this growing population.

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