Spertus, John A.

Background: In light of well-known deficiencies in the process of informed consent for percutaneous coronary intervention (PCI), we developed and tested a personalized consent form, PRISM; this was shown to improve patients' participation in the consent process, understanding of procedural risks, and engagement in shared decision-making when compared to original PCI consent forms. It is unknown whether patient factors traditionally known to impair the consent process, including socioeconomic status, literacy and numeracy, were associated with greater benefit from the PRISM consents. Methods: We interviewed 590 patients receiving original consent documents and 527 receiving PRISM consents and compared the rates of reviewing the consent form, recalling a risk of bleeding and engaging in discussions about stent type using hierarchical modified Poisson regression analysis. The interaction of patient factors (age, gender, education level, insurance status, literacy and numeracy) with PRISM on outcomes was assessed. Results: Overall, few patient characteristics were associated with outcomes, including review of consent forms, knowledge transfer, or engagement in shared decision-making (see Table), although older patients were less likely to discuss stent types with their doctors (RR=0.84/decade for original and 0.93/decade for PRISM). Those with more than a high school education were less likely to review original consents (RR=0.77; 95% CI=0.66, 0.89) compared to those with less education; this difference was eliminated with the PRISM consents (RR=1.0; 95%CI=0.82, 1.23; p-value for interaction = 0.01). Conclusions: PRISM consent forms led to improved participation in the consent process and knowledge transfer in a 9-center study; there was little variance by sociodemographic, economic, literacy or numeracy factors, both with original consents and with PRISM.

Background. Measurement of PCI quality has previously focused on post-procedure outcomes and processes of care. PCI appropriateness provides an assessment of quality as it relates to patient selection and anticipated procedural benefit relative to potential harm. The relationship, if any, between case selection and in-hospital procedural outcomes is unknown. Methods. We identified 203,531 consecutive patients from 779 hospitals undergoing non-acute (elective) PCI within the CathPCI Registry ® between July, 2009 and April, 2011. We examined the association between a hospital’s proportion of inappropriate PCI in non-acute settings (as assessed by the Appropriate Use Criteria (AUC) for Coronary Revascularization) and (1) risk-adjusted in-hospital mortality; (2) risk-adjusted bleeding complications; and (3) use of optimal guideline directed discharge medications (i.e. aspirin, thienopyridine, and statin on discharge). Results. Of the 24,532 patients who received PCI for non-acute indications, 453 (0.2%) died in-hospital and 3699 (1.8%) suffered bleeding events. The hospital proportion of inappropriate PCI in non-acute settings ranged from 0.0% to 58.6%. Categorized as hospital tertiles, the median proportion of inappropriate PCI was 5.3% in hospitals of the lowest-tertile, 10.9% in the middle-tertile, and 20.0% in the highest-tertile. The hospital proportion of inappropriate PCI was not associated with mortality for PCI in non-acute settings (Risk-adjusted mortality ratio; 0.7 vs. 0.7 vs. 0.8 from lowest to highest-tertile, P=0.75 for trend), risk-adjusted bleeding complications (Risk-adjusted bleeding ratio; 0.6 vs. 0.6 vs. 0.6, P=0.81), or use of optimal PCI discharge medications (85.3% vs. 85.7% vs. 85.2%, P=0.58). Conclusions. In a national cohort of non-acute PCIs from 779 hospitals, hospital proportion of inappropriate PCI indications was not associated with in-hospital mortality, bleeding, or process of care measures of PCI quality. These findings suggest PCI appropriateness and post-procedural outcomes measure different aspects of hospital PCI quality.

Background: While lack of insurance is known to be associated with worse outcomes after myocardial infarction (MI), it is unknown whether health insurance status is associated with rates of non-elective hospitalizations after MI. Methods: Using data on 3571 U.S. MI patients enrolled between April 2005 to December 2008 in the 24-center, prospective TRIUMPH registry, we examined the association between being insured (reference), underinsured, and uninsured on rates of non-elective readmissions (all-cause) in the 1 st year following MI. Insurance status was obtained from medical records, and underinsurance was defined as those patients with insurance but with financial concerns about accessing care from patient interviews. Multivariable modified Poisson regression models were used to adjust for site, demographics, MI severity, risk factors, socio-economic, and psychological factors. Results: A total of 2269 (63.5%) patients were insured; 650 (18.2%) were underinsured; and 652 (18.3%) were uninsured. Emergency readmissions were highest for uninsured patients (25.0%), followed by the underinsured (21.8%), and lowest in insured patients (19.5%) (P<.001). After multivariable adjustment, uninsured patients had significantly higher rates of emergency readmission (adjusted RR, 1.52 [95% CI: 1.22-1.90] while underinsured patients did not (adjusted RR, 0.99 [95% CI: 0.81-1.21]) (Figure). Conclusions: Uninsured patients had a significantly higher adjusted risk of non-elective readmissions after MI, while underinsured patients did not. Future studies are needed to determine if providing even modest insurance coverage to the uninsured can minimize readmission rates.

Background: The Kansas City Cardiomyopathy Questionnaire (KCCQ) has been psychometrically evaluated in multiple heart failure (HF) populations, but the comparability of its psychometric properties between men and women is unknown. Methods: Data from 3 clinical trials (1 in stable HF with preserved ejection fraction, 1 each in stable and acute HF with reduced ejection fraction) and 1 prospective cohort study (stable HF with reduced ejection fraction), incorporating 6773 men and 3612 women with HF, were used to compare the construct validity, internal and test-retest reliability, ability to detect change, predict mortality and hospitalizations and minimally important differences between the 2 sexes. Interactions of the KCCQ overall summary and subdomain scores by sex were independently examined. Results: The KCCQ-Overall Summary score correlated well with New York Heart Association functional class in both sexes across patients with stable (correlation coefficient: −0.40 in men versus −0.49 in women) and acute (−0.37 in men versus −0.34 in women) HF. All KCCQ subdomains demonstrated concordant relationships with relevant comparison standards with no significant interactions by sex in 19 of 21 of these construct validity analyses. All KCCQ scores were equally predictive and other psychometric evaluations showed similar results by sex: test-retest reliability (intraclass correlation coefficient 0.94 in men versus 0.92 in women), responsive to change (standardized response mean 1.01 in both sexes), as were the minimally important differences and internal reliability. Conclusions: The psychometric properties of the KCCQ, in terms of validity, prognosis, reliability, and sensitivity to change, are comparable in men and women with HF with preserved ejection fraction and HF with reduced ejection fraction.

Background: One month following a myocardial infarction (MI), more than a third of older adults (age ≥65 years) are frail as demonstrated by slow gait speed (≤ 0.65 m/sec). The prognostic significance of frailty in a cardiovascular population in terms of future health states is unknown. Methods: The TRIUMPH longitudinal registry enrolled 1314 older adults (age ≥65 years) following an acute MI from 24 US centers. Gait speed (m/sec) was determined at one month (to allow for acute recovery) in 329 patients with in-home follow up. Using averages of 3 timed walks over 15-feet, patients were stratified by gait speed into 2 groups: slow (<0.65m/sec) and preserved (≥0.65m/sec). One year basic (mobility, self care) and instrumental activities of daily living (ADL) (phone, meds, travel, money), physical function score (SF12 PCS), quality of life (Seattle Angina Questionnaire (SAQ)), and mortality were assessed. Results: Slow gait speed was present in 38% (N=126) of older adults at 1 month. At 1 year, despite similar survival, frail adults were much more likely to need help with basic and instrumental (ADL), and had lower physical function and quality of life (QOL) compared to non-frail adults. ( table ) Slower gait speed remained a significant predictor of worse physical function at 1 year after adjustment for baseline physical function (p=0.013). Conclusions: Frailty is common in older adults following an MI, and those with frailty are at substantial risk for continued impairment over time. Understanding the mechanisms or reversibility of this vulnerable state would contribute to optimization of independence and quality of life among older adults with cardiovascular disease. Frailty Post MI and 1 Year Outcomes Frail (Gait <0.65m/sec)N=126 Not Frail (Gait ≥0.65m/sec)N=203 P value Mobility ADL (% need help) 45 23 <0.001 Self-Care ADL (% need help) 11 4 <0.001 Instrumental ADLs (% need help) 36 19 0.003 Physical Function (PCS) 39.2 ± 12.0 47.2 ± 9.7 <0.001 SAQ Quality of Life (QOL) 88.0 ± 15.9 91.3 ± 12.1 0.061 Mortality (%) 5.6 4.5 NS

Background: The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) survey has recently been validated to measure the impact of atrial fibrillation on patients’ quality of life, but a clinically important difference (CID) in AFEQT score has not been defined. Knowing the CID is needed to interpret the meaningfulness of differences between treatments in clinical trials; or patient populations for quality assessment. Objectives: To calculate CID values in AFEQT in the ORBIT registry. Methods: ORBIT-AF is a US-based outpatient AF registry that measured disease-specific QoL with the AFEQT tool (score range= 0 (worst) to 100) at baseline and at 1 year follow-up. Two anchor-based methods were used to relate changes in AFEQT to clinically important differences in the more established European Heart Rhythm Association (EHRA) measure of functional status. Ranging from 1 (no symptoms) to 4 (disabling), a change of 1 EHRA class was defined as an important change in the anchor. Both the mean change and receiver operating characteristics (ROC) methods were then used to identify CIDs in AFEQT at 1 year follow-up. This was done for both improvement and worsening on the anchor. The mean change method defines a CID as the mean change in AFEQT score among patients with a 1 EHRA class change. The ROC method identifies a CID as the point on the ROC curve that best discriminates patients who experienced an important change in the anchor (≥ 1 EHRA class change) from those who experienced no change. Results: AFEQT was assessed in 2008 AF patients at baseline and 1347 patients at 1 year from 99 US sites participating in ORBIT-AF. CIDs and 95% confidence intervals (CI) corresponding to an improvement in EHRA for the mean change method were 5.4 (3.6, 7.2) AFEQT points and 1.9 (0.4, 9.3) AFEQT points for the ROC method. CIDs corresponding to worsening in EHRA for the mean change method were -4.2 (-6.9,-1.5) AFEQT points and -7.4 (-13.9,-4.6) AFEQT points for the ROC method. Conclusions: Changes in AFEQT as small as 2 points may be clinically relevant, although CIDs vary depending on the method of calculation. The variability suggests identifying a single universal CID to assess improvement in quality of life in AF patients may not be ideal and improvement may relate to the nature of a patient’s symptoms and their baseline level of activity.

Background: After left ventricular assist device (LVAD) for end-stage heart failure, cognitive function should improve due to increased cerebral perfusion. However, stroke (a well-known LVAD complication) and even subclinical cerebral ischemia may also occur and manifest as transient or permanent cognitive decline. We sought to describe the incidence and predictors of cognitive decline after LVAD using a valid, sensitive assessment tool. Methods: As part of the INTERMACS registry, cognitive function was assessed before LVAD and at each follow-up with the Trailmaking B Test (TBT), where a subject is timed connecting 25 dots labeled with alternating, consecutive numbers and letters (1, A, 2, B, etc.). The TBT can detect several forms of cognitive impairment, including subclinical stroke. Longer times are worse, and cognitive decline was defined as a clinically important increase from baseline to highest follow-up score using Cohen’s D Effect Size (0.2*baseline SD = 13 s). Patients who completed baseline and at least 1 follow-up TBT were included. Multivariable logistic regression was used to examine the association between patient characteristics and cognitive decline after LVAD. Results: Among 1151 LVAD patients, median age was 60-69, 19% were female, and 40% were INTERMACS profile 1-2 (cardiogenic shock or declining despite inotropes) at implant. Among patients with 12-mo follow-up, mean TBT score improved from 126 at baseline to 123 at 1 yr. In the total cohort, 333 (29%) patients had significant cognitive decline within 12 mo of LVAD placement. Increasing age, chronic renal disease, better baseline TBT score (shorter time), and higher INTERMACS profiles (≥ 3; less severe heart failure) were significantly associated with greater odds of cognitive decline (Figure). Conclusion: In a large LVAD registry, cognitive decline occurred in over a quarter of patients in the year after LVAD and was associated with older age, renal disease, higher baseline cognitive function, and more stable heart failure at implant. These results define the frequency of an important adverse event and provide new insights regarding outcomes after LVAD. Future studies are needed to explore the association of transient and permanent cognitive decline with subsequent stroke, health status, and mortality in patients after LVAD placement.

Background: While concerns about the safety and procedural success of radial, as opposed to femoral, access for PCI have largely been abated, the association of radial access with patients’ health status recovery has not been explored. To address this gap in knowledge, we compared the symptoms, physical function and quality of life 1 year after PCI in patients treated with radial, as compared with femoral, access. Methods: This is a 10-center study of PCI, in whom 48 of 139 (35%) interventionalists used both radial and femoral approaches between 2009-2010. A total 2628 patients without prior CABG were interviewed and followed for one year. The previously validated Seattle Angina Questionnaire (SAQ) was used to assess disease-specific health status and the EQ-5D was used to quantify generic quality of life. Clinical characteristics and health status outcomes were compared between 296 radial and 2332 femoral PCI procedures. Results: Radial access was used in 11.2% of patients. No demographic (age, gender, race) or clinical factors (e.g. BMI, smoking, diabetes, hypertension, renal disease or prior cardiac history) were associated with radial use, except for an increased use among those with PAD (10.5% radial vs. 6.8% femoral, p=0.022) but reduced use among those with prior PCI (38.3% vs. 32.1%, p=0.037). There was no difference in health status outcomes based on SAQ angina frequency and quality of life, or the EQ-5D at baseline, 6 months or one year (table). Conclusion: In this multi-center observational registry, there was no association of radial access with long-term health status outcomes. These data suggest that there are no offsetting concerns about patients’ long-term health status benefits to counterbalance the peri-procedural safety benefits of a radial approach.

Background: With increasing options for treating atrial fibrillation (AF), it is important to understand and quantify patient symptoms and quality of life (QoL), as improving symptoms and maximizing QoL are primary treatment goals. However, little is known about the factors associated with QoL. Methods: The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) is a disease-specific QoL tool for AF, with domain and summary scores ranging from 0 (the worst health status) to 100. Using hierarchical pseudo-binomial regression, we evaluated factors associated with baseline AFEQT Summary and Subscale scores in the ORBIT AF registry. Adjusted associations were reported as odds ratios (OR) and 95% confidence intervals (CI). Results: AFEQT was assessed in 2,007 AF outpatients from 99 sites. Median age and interquartile range (IQR) was 76 (67-82); 43% were female; and the median CHA2DS2-VASC score was 4 (3-5). Median AFEQT summary score was 82 (67, 94). Median symptom score was 92 (78-100) and daily activity score was 77 (52-94). Female sex, younger age, new onset AF, higher heart rate, obstructive sleep apnea, and CAD were all associated with reduced QoL. (Table) Similar trends were seen for the symptoms subscale: female sex [OR 0.57 CI (0.48, 0.68)], younger age [OR 1.10 CI (1.06, 1.15)], and new onset AF [OR 0.55 CI (0.43, 0.70)] were associated with worse symptoms. Likewise, for the daily activities subscale, Other race [OR 0.54 CI (0.36-0.80)] and higher BMI [OR 0.98 CI (0.98-0.99)] were associated with decreased activity. Conclusions: In the largest community-based assessment of QoL in patients with AF, we found several patient factors to be associated with low QoL, including female sex, new onset AF, younger age, higher heart rate, and certain cardiopulmonary comorbidities. Understanding patient characteristics associated with worse QoL can be a foundation for eradicating disparities and tailoring treatment.

Background: The presence of frailty increases the risk of long-term mortality for a myriad of reasons, but its association with cardiac-specific mortality among the elderly undergoing percutaneous coronary intervention (PCI) is unknown. We sought to determine the relationship between frailty and cause-specific (cardiac versus non-cardiac) mortality among elderly patients undergoing PCI. Methods: A prospective cohort of elderly (>65 years) patients undergoing PCI at Mayo Clinic between October 2005 and September 2008 were tested for frailty using the Fried criteria. Vital status was prospectively monitored including evaluation of death certificates, telephone interviews and review of autopsy/medical records. Results: Frailty data was obtained in 428 (84%) of 508 elderly patients (median age 74.2 years [SD 6.4, range 65-100]; 59% male). Of these, 92 (21%) patients were frail while 231 (54%) had intermediate frailty and 105(25%) were not frail. Frail patients were older than intermediate and non-frail patients (77.6 vs 74.3 vs 71.0 years; p<0.001) and had more comorbidities (mean Charlson index 4.6 vs 3.9 vs 2.8; p<0.001). There were 113 deaths (26% of cohort) during 5.1 median years of follow-up, of which 77 (68%) were classified as non-cardiac and 36 (32%) which were classified as cardiac. Frailty at baseline was associated with poor overall survival compared to non-frail patients (HR 6.1, 95% CI 3.2, 11.6; p<0.001). The estimated effect of frailty was nearly 3 times greater for cardiac mortality (HR 13.1, 95% CI 3.0, 57.0; p=0.001) than non-cardiac mortality (HR 4.6, 95% CI 2.2, 9.7; p<0.001). These findings remained significant following multivariable adjustment. Conclusions: Frailty is common among elderly patients undergoing PCI and is associated with poor overall survival and both cardiac and non-cardiac causes of death.