Development of Complementary Encounter and Patient Decision Aids for Shared Decision Making about Stroke Prevention in Atrial Fibrillation.

Introduction: Decision aids (DAs) are helpful instruments used to support shared decision making (SDM). Patients with atrial fibrillation (AF) face complex decisions regarding stroke prevention strategies. While a few DAs have been made for AF stroke prevention, an encounter DA (EDA) and patient DA (PDA) have not been created to be used in conjunction with each other before. Design: Using iterative user-centered design, we developed 2 DAs for anticoagulation choice and stroke prevention in AF. Prototypes were created, and we elicited feedback from patients and experts via observations of encounters, usability testing, and semistructured interviews. Results: User testing was done with 33 experts (in AF and SDM) and 51 patients from 6 institutions. The EDA and PDA underwent 1 and 4 major iterations, respectively. Major differences between the DAs included AF pathophysiology and a preparation to meet with the clinician in the PDA as well as different language throughout. Content areas included personalized stroke risk, differences between anticoagulants, and risks of bleeding. Based on user feedback, developers 1) addressed feelings of isolation with AF, 2) improved navigation options, 3) modified content and flow for users new to AF and those experienced with AF, 4) updated stroke risk pictographs, and 5) added structure to the preparation for decision making in the PDA. Limitations: These DAs focus only on anticoagulation for stroke prevention and are online, which may limit participation for those less comfortable with technology. Conclusions: Designing complementary DAs for use in tandem or separately is a new method to support SDM between patients and clinicians. Extensive user testing is essential to creating high-quality tools that best meet the needs of those using them. Highlights: First-time complementary encounter and patient decision aids have been designed to work together or separately.User feedback led to greater structure and different experiences for patients naïve or experienced with anticoagulants in patient decision aids.Online tools allow for easier dissemination, use in telehealth visits, and updating as new evidence comes out.

Randomized evaluation of decision support interventions for atrial fibrillation: Rationale and design of the RED-AF study.

BACKGROUND: Shared decision making (SDM) improves the likelihood that patients will receive care in a manner consistent with their priorities. To facilitate SDM, decision aids (DA) are commonly used, both to prepare a patient before their clinician visit, as well as to facilitate discussion during the visit. However, the relative efficacy of patient-focused or encounter-based DAs on SDM and patient outcomes remains largely unknown. We aim to directly estimate the comparative effectiveness of two DA's on SDM observed in encounters to discuss stroke prevention strategies in patients with atrial fibrillation (AF). METHODS: The study aims to recruit 1200 adult patients with non-valvular AF who qualify for anticoagulation therapy, and their clinicians who manage stroke prevention strategies, in a 2x2 cluster randomized multi-center trial at six sites. Two DA's were developed as interactive, online, non-linear tools: a patient decision aid (PDA) to be used by patients before the encounter, and an encounter decision aid (EDA) to be used by clinicians with their patients during the encounter. Patients will be randomized to PDA or usual care; clinicians will be randomized to EDA or usual care. RESULTS: Primary outcomes are quality of SDM, patient decision making, and patient knowledge. Secondary outcomes include anticoagulation choice, adherence, and clinical events. CONCLUSION: This trial is the first randomized, head-to-head comparison of the effects of an EDA versus a PDA on SDM. Our results will help to inform future SDM interventions to improve patients' AF outcomes and experiences with stroke prevention strategies.

Indication alerts to improve problem list documentation.

BACKGROUND: Problem lists represent an integral component of high-quality care. However, they are often inaccurate and incomplete. We studied the effects of alerts integrated into the inpatient and outpatient computerized provider order entry systems to assist in adding problems to the problem list when ordering medications that lacked a corresponding indication. METHODS: We analyzed medication orders from 2 healthcare systems that used an innovative indication alert. We collected data at site 1 between December 2018 and January 2020, and at site 2 between May and June 2021. We reviewed random samples of 100 charts from each site that had problems added in response to the alert. Outcomes were: (1) alert yield, the proportion of triggered alerts that led to a problem added and (2) problem accuracy, the proportion of problems placed that were accurate by chart review. RESULTS: Alerts were triggered 131 134, and 6178 times at sites 1 and 2, respectively, resulting in a yield of 109 055 (83.2%) and 2874 (46.5%), P< .001. Orders were abandoned, for example, not completed, in 11.1% and 9.6% of orders, respectively, P<.001. Of the 100 sample problems, reviewers deemed 88% ± 3% and 91% ± 3% to be accurate, respectively, P = .65, with a mean of 90% ± 2%. CONCLUSIONS: Indication alerts triggered by medication orders initiated in the absence of a justifying diagnosis were useful for populating problem lists, with yields of 83.2% and 46.5% at 2 healthcare systems. Problems were placed with a reasonable level of accuracy, with 90% ± 2% of problems deemed accurate based on chart review.

Cases from a busy nuclear cardiology laboratory: Potential pitfalls in the interpretation of cardiac scintigraphy for ATTR cardiac amyloidosis.

Cardiac scintigraphy has emerged as a key diagnostic test for transthyretin cardiac amyloidosis (ATTR-CA). However, there are potential limitations and pitfalls in the interpretation of cardiac scintigraphy for ATTR-CA that are worth noting. We present here a series of three cases which illustrate some of these important principles.

Leveraging electronic health record documentation for Failure Mode and Effects Analysis team identification.

OBJECTIVE: Using Failure Mode and Effects Analysis (FMEA) as an example quality improvement approach, our objective was to evaluate whether secondary use of orders, forms, and notes recorded by the electronic health record (EHR) during daily practice can enhance the accuracy of process maps used to guide improvement. We examined discrepancies between expected and observed activities and individuals involved in a high-risk process and devised diagnostic measures for understanding discrepancies that may be used to inform quality improvement planning. METHODS: Inpatient cardiology unit staff developed a process map of discharge from the unit. We matched activities and providers identified on the process map to EHR data. Using four diagnostic measures, we analyzed discrepancies between expectation and observation. RESULTS: EHR data showed that 35% of activities were completed by unexpected providers, including providers from 12 categories not identified as part of the discharge workflow. The EHR also revealed sub-components of process activities not identified on the process map. Additional information from the EHR was used to revise the process map and show differences between expectation and observation. CONCLUSION: Findings suggest EHR data may reveal gaps in process maps used for quality improvement and identify characteristics about workflow activities that can identify perspectives for inclusion in an FMEA. Organizations with access to EHR data may be able to leverage clinical documentation to enhance process maps used for quality improvement. While focused on FMEA protocols, findings from this study may be applicable to other quality activities that require process maps.

Influence of beta-blocker therapy on aortic blood flow in patients with bicuspid aortic valve.

In patients with bicuspid aortic valve (BAV), beta-blockers (BB) are assumed to slow ascending aorta (AAo) dilation by reducing wall shear stress (WSS) on the aneurysmal segment. The aim of this study was to assess differences in AAo peak velocity and WSS in BAV patients with and without BB therapy. BAV patients receiving BB (BB+, n = 30, age: 47 ± 11 years) or not on BB (BB-, n = 30, age: 46 ± 13 years) and healthy controls (n = 15, age: 43 ± 11 years) underwent 4D flow MRI for the assessment of in vivo aortic 3D blood flow. Peak systolic velocities and 3D WSS were calculated at the anterior and posterior walls of the AAo. Both patient groups had higher maximum and mean WSS relative to the control group (p = 0.001 to p = 0.04). WSS was not reduced in the BB+ group compared to BB- patients in the anterior AAo (maximum: 1.49 ± 0.47 vs. 1.38 ± 0.49 N/m(2), p = 0.99, mean: 0.76 ± 0.2 vs. 0.74 ± 0.18 N/m(2), p = 1.00) or posterior AAo (maximum: 1.45 ± 0.42 vs. 1.39 ± 0.58 N/m(2), p = 1.00; mean: 0.65 ± 0.16 vs. 0.63 ± 0.16 N/m(2), p = 1.00). AAo peak velocity was elevated in patients compared to controls (p < 0.01) but similar for BB+ and BB- groups (p = 0.42). Linear models identified significant relationships between aortic stenosis severity and increased maximum WSS (ß = 0.186, p = 0.007) and between diameter at the sinus of Valsalva and reduced mean WSS (ß = -0.151, p = 0.045). Peak velocity and systolic WSS were similar for BAV patients irrespective of BB therapy. Further prospective studies are needed to investigate the impact of dosage and duration of BB therapy on aortic hemodynamics and development of aortopathy.

Bicuspid aortic cusp fusion morphology alters aortic three-dimensional outflow patterns, wall shear stress, and expression of aortopathy.

BACKGROUND: Aortic 3-dimensional blood flow was analyzed to investigate altered ascending aorta (AAo) hemodynamics in bicuspid aortic valve (BAV) patients and its association with differences in cusp fusion patterns (right-left, RL versus right-noncoronary, RN) and expression of aortopathy. METHODS AND RESULTS: Four-dimensional flow MRI measured in vivo 3-dimensional blood flow in the aorta of 75 subjects: BAV patients with aortic dilatation stratified by leaflet fusion pattern (n=15 RL-BAV, mid AAo diameter=39.9±4.4 mm; n=15 RN-BAV, 39.6±7.2 mm); aorta size controls with tricuspid aortic valves (n=30, 41.0±4.4 mm); healthy volunteers (n=15, 24.9±3.0 mm). Aortopathy type (0-3), systolic flow angle, flow displacement, and regional wall shear stress were determined for all subjects. Eccentric outflow jet patterns in BAV patients resulted in elevated regional wall shear stress (P<0.0125) at the right-anterior walls for RL-BAV and right-posterior walls for RN-BAV in comparison with aorta size controls. Dilatation of the aortic root only (type 1) or involving the entire AAo and arch (type 3) was found in the majority of RN-BAV patients (87%) but was mostly absent for RL-BAV patients (87% type 2). Differences in aortopathy type between RL-BAV and RN-BAV patients were associated with altered flow displacement in the proximal and mid AAo for type 1 (42%-81% decrease versus type 2) and distal AAo for type 3 (33%-39% increase versus type 2). CONCLUSIONS: The presence and type of BAV fusion was associated with changes in regional wall shear stress distribution, systolic flow eccentricity, and expression of BAV aortopathy. Hemodynamic markers suggest a physiological mechanism by which the valve morphology phenotype can influence phenotypes of BAV aortopathy.

Relation of body mass index to late survival after valvular heart surgery.

Limited data have suggested that an "obesity paradox" exists for mortality and cardiovascular outcomes in patients undergoing coronary artery bypass grafting. Much less is known about the role of the preoperative body mass index (BMI) in patients undergoing valve surgery. We evaluated 2,640 consecutive patients who underwent valve surgery between April 2004 and March 2011. The patients were classified by the World Health Organization standards as "underweight" (BMI 11.5 to 18.4 kg/m(2), n = 61), "normal weight" (BMI 18.5 to 24.9 kg/m(2), n = 865), "overweight" (BMI 25 to 29.9 kg/m(2), n = 1,020), and "obese" (BMI 30 to 60.5 kg/m(2), n = 694). Mortality was ascertained using the Social Security Death Index. Hazard ratios (HRs), adjusted for known preoperative risk factors, were obtained using Cox regression models. The mean follow-up was 31.9 ± 20.5 months. The long-term mortality rate was 1.21, 0.52, 0.32, and 0.44 per 10 years of person-time for underweight, normal, overweight, and obese patients, respectively. Compared to the normal BMI category, overweight patients (adjusted HR 0.60, 95% confidence interval 0.46 to 0.79, p <0.001) and obese patients (adjusted HR 0.67, 95% confidence interval 0.50 to 0.91, p = 0.009) were at a lower hazard of long-term all-cause mortality. Underweight patients remained at a greater adjusted risk of long-term mortality than normal weight patients (adjusted HR 1.69, 95% confidence interval 1.01 to 2.85, p = 0.048). Similar patterns of mortality outcomes were noted in the subset of patients undergoing isolated valve surgery. In conclusion, overweight and obese patients had greater survival after valve surgery than patients with a normal BMI. Very lean patients undergoing valve surgery are at a greater hazard for mortality and might require more rigorous preoperative candidate screening and closer postoperative monitoring.

Early readmission for congestive heart failure predicts late mortality after cardiac surgery.

OBJECTIVE: Early readmission in patients hospitalized for medical congestive heart failure is common, expensive, and associated with a worse late survival. Our objective was to compare late survival in patients' readmission for congestive heart failure with readmission for other causes in patients undergoing cardiac surgery. METHODS: Of 3654 consecutive patients undergoing cardiac surgery at a single institution between April 2004 and June 2010, 3492 (96%) were discharged from the hospital before 30 days and analyzed. Survival curves by readmission reason were compared using the log-rank test. Multivariable analyses adjusted for patient demographics, known preoperative cardiac risk factors, and surgical characteristics. RESULTS: The readmission rate at 30 days was 13% (465/3492): 23% for arrhythmias/heart block, 12% for congestive heart failure, 40% for surgery related causes, 14% for infection, and 11% for noncardiac causes. Independent risk factors for readmission include age, gender, congestive heart failure, and cardiopulmonary bypass time. Eight percent (268/3492) of discharged patients died within the 6-year study: 14% in the readmission group versus 7% in the nonreadmission group (P < .01). Patients who had been readmitted for congestive heart failure had worse late survivals compared with all patients who had been readmitted for causes related to their surgery. CONCLUSIONS: Readmission within 30 days after cardiac surgery for congestive heart failure predicts late mortality. Targeted postoperative management may be warranted in patients with surgical congestive heart failure.

Midterm benefits of preoperative statin therapy in patients undergoing isolated valve surgery.

BACKGROUND: Recent data have suggested that statins are associated with reduced early mortality and cardiovascular events after valvular heart surgery. The midterm effects of preoperative statin therapy in the setting of valvular heart surgery are presently unclear. METHODS: All patients (n=2,120) who underwent a valvular procedure between April 2004 and April 2010 were identified. Patients undergoing concomitant coronary artery bypass graft surgery were excluded. Two patient groups were studied: those who received preoperative statin therapy (n=663; 31.3%) and those who did not (n=1,457; 68.7%). Propensity score matching resulted in 381 matched pairs, thus addressing baseline risk imbalances. Thirty-day mortality, readmission rates, postoperative complications, and length of stay were analyzed. Late survival was ascertained by the Social Security Death Index. RESULTS: In the matched group, 30-day mortality was 1.3% (5 of 381) for statin-treated patients versus 4.2% (16 of 381) for statin-untreated patients (p=0.03). After a mean follow-up of 33±23 months, statin therapy was associated with significantly reduced mortality (hazard ratio 0.63, 95% confidence interval: 0.43 to 0.93, p=0.019), independent of known cardiac risk factors. Weighted log rank tests revealed that the mortality difference between the two cohorts occurred early after surgery (p=0.015). Statin users were less likely to be readmitted to the intensive care unit (3.4% versus 8.1%, p=0.01). There were no other significant differences between the two groups in terms of postoperative complications and length of stay. CONCLUSIONS: Preoperative statin administration is associated with early reductions in mortality among patients undergoing isolated valvular heart surgery, leading to improved late survival. Future prospective analyses are warranted to optimize statin therapy in this patient population.

Perioperative statin therapy reduces mortality in normolipidemic patients undergoing cardiac surgery.

OBJECTIVE: Statins might have pleiotropic effects, independent of their ability to reduce lipid levels. Recent data have suggested that statins improve early survival and cardiovascular outcomes after coronary artery bypass graft surgery. The effectiveness of statin therapy in normolipidemic cardiac surgery patients is as yet unclear. METHODS: We evaluated 3056 consecutive patients who had undergone cardiac surgery between April 2004 and April 2009. Perioperative statin therapy was defined as continued treatment both before (≥ 6 months) and after the index surgery (included as a discharge medication). Hyperlipidemia (HL) was defined as a total cholesterol level greater than 200 mg/dL within 6 months before surgery. Four groups were analyzed: (1) statin-untreated normolipidemic (NL-, n = 1052); (2) statin-treated normolipidemic (NL+, n = 206); (3) statin-untreated hyperlipidemic (HL-, n = 638); and (4) statin-treated hyperlipidemic (HL+, n = 1160) patients. Adjusted hazard ratios accounted for the known preoperative cardiac risk factors. Mortality was ascertained by retrospective database review and the Social Security Death Index. RESULTS: The mean follow-up was 2.2 years. The crude rate of 30-day mortality was 3.0% (32/1052), 0% (0/206), 8.0% (51/638), and 0.7% (8/1160) for the NL-, NL+, HL-, and HL+ groups, respectively. The overall all-cause crude mortality rate was 9.6% (101/1052), 3.9% (8/206), 17.2% (110/638), and 6.5% (75/1160) for the NL-, NL+, HL-, and HL+ groups, respectively. Statin therapy for NL patients undergoing cardiac surgery independently reduced the overall all-cause mortality (adjusted hazard ratio, 0.34; 95% confidence interval, 0.16-0.71; P = .004). CONCLUSIONS: Perioperative statin therapy was associated with reduced mid-term mortality for patients undergoing cardiac surgery, irrespective of their baseline lipid status. This clinical evidence suggests that the beneficial effects of statins might extend beyond their lipid-lowering ability.

Angiographic estimates of myocardium at risk during acute myocardial infarction: validation study using cardiac magnetic resonance imaging.

AIMS: Global angiographic scores have been developed to determine the extent of myocardium jeopardized by significant coronary stenosis. We adapted these scores to quantify the anatomic area at risk during acute myocardial infarction. We used contrast-enhanced magnetic resonance (CMR) infarct imaging to measure the portion of myocardium that developed necrosis within the so defined angiographic area at risk. METHODS AND RESULTS: In 83 subjects presenting for primary percutaneous intervention, the myocardium at risk was estimated angiographically using the Myocardial Jeopardy Index (BARI) and a modified version of the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) scores. CMR was performed within a week to measure infarct size, infarct endocardial surface area (infarct-ESA), and infarct transmurality. As infarct transmurality increased, the infarct size closely approximated the myocardium at risk by angiography. In 35 subjects with transmural infarcts, the area at risk by BARI and APPROACH scores matched the infarct size (r = 0.90 and r = 0.92, P < 0.001). Additionally, BARI and APPROACH scores matched the infarct-ESA in all subjects independently of collateral flow and time to reperfusion (r = 0.90 and r = 0.87, P < 0.001). The presence of early reperfusion, collaterals, or both was associated with a progressive decrease in infarct transmurality (P < 0.001 for trend) with no difference in the infarct-ESA. CONCLUSION: The myocardium at risk of infarction can be determined angiographically as validated in subjects with transmural myocardial infarcts. Salvage provided by early reperfusion or collaterals occurs by limiting infarct transmurality, thereby the extent of endocardial infarct involved also allows estimation of the myocardium at risk in patients presenting with STEMI.

Gender differences in the value of ST-segment depression during adenosine stress testing.

Previous studies have suggested that ST-segment depression with adenosine myocardial perfusion imaging (MPI) may be a marker of significant coronary artery disease (CAD). It is unclear if the significance of ST depression differs between men and women. We investigated the diagnostic accuracy of ST-segment depression with adenosine radionuclide MPI as a marker of significant CAD in men and women. Consecutive patients who had angina or suspected CAD and underwent an adenosine stress test and subsequent angiography were retrospectively analyzed. The inclusion criteria were met by 959 patients. Mean age was 64 +/- 11 years, and 43% were women. ST depression occurred in 7.6% of the cohort and more often in women (64% women vs 36% men, p <0.001). Among men and women, patients with ST-segment depression had a significantly higher peak rate-pressure product, more chest pain, and a higher ejection fraction in response to the adenosine infusion compared with those without ST-segment depression. ST-segment depression occurred more often in the presence of stenotic lesions (>/=50% and >/=70%), and left main or 3-vessel disease, regardless of gender. Transient ischemic dilation occurred more often in men with ST-segment depression. The logistic regression analysis demonstrated that the only significant predictors of left main or 3-vessel CAD were gender, an abnormal result on MPI, transient ischemic dilation, and ST-segment depression. In conclusion, ST-segment depression during adenosine MPI is an important marker of angiographically significant CAD in men and women. The presence of ST-segment depression is associated with left main disease and 3-vessel CAD.