Patients' Experiences Using a Mobile Health App for Self-Care of Heart Failure in a Real-World Setting: Qualitative Analysis.

BACKGROUND: Publicly available patient-focused mobile health (mHealth) apps are being increasingly integrated into routine heart failure (HF)-related self-care. However, there is a dearth of research on patients' experiences using mHealth apps for self-care in real-world settings. OBJECTIVE: The purpose of this study was to explore patients' experiences using a commercially available mHealth app, OnTrack to Health, for HF self-care in a real-world setting. METHODS: Patient satisfaction, measured with a 5-point Likert scale, and an open-ended survey were used to gather data from 23 patients with HF who were provided the OnTrack to Health app as a part of routine HF management. A content analysis of patients' responses was conducted with the qualitative software Atlas.ti (version 8; ATLAS.ti Scientific Software Development GmbH). RESULTS: Patients (median age 64, IQR 57-71 years; 17/23, 74% male) used OnTrack to Health for a median 164 (IQR 51-640) days before the survey. All patients reported excellent experiences related to app use and would recommend the app to other patients with HF. Five themes emerged from the responses to the open-ended questions: (1) features that enhanced self-care of HF (medication tracker, graphic performance feedback and automated alerts, secured messaging features, and HF self-care education); (2) perceived benefits (provided assurance of safety, improved HF self-care, and decreased hospitalization rates); (3) challenges with using apps for self-care (giving up previous self-care strategies); (4) facilitators (perceived ease of use and availability of technical support); and (5) suggested improvements (streamlining data entry, integration of apps with an electronic medical record, and personalization of app features). CONCLUSIONS: Patients were satisfied with using OnTrack to Health for self-care. They perceived the features of the app as valuable tools for improving self-care ability and decreasing hospitalization rates. The development of apps in collaboration with end users is essential to ensure high-quality patient experiences related to app use for self-care.

Empagliflozin Effects on Pulmonary Artery Pressure in Patients With Heart Failure: Results From the EMBRACE-HF Trial.

BACKGROUND: Sodium glucose cotransporter 2 inhibitors (SGLT2 inhibitors) prevent heart failure (HF) hospitalizations in patients with type 2 diabetes and improve outcomes in those with HF and reduced ejection fraction, regardless of type 2 diabetes. Mechanisms of HF benefits remain unclear, and the effects of SGLT2 inhibitor on hemodynamics (filling pressures) are not known. The EMBRACE-HF trial (Empagliflozin Evaluation by Measuring Impact on Hemodynamics in Patients With Heart Failure) was designed to address this knowledge gap. METHODS: EMBRACE-HF is an investigator-initiated, randomized, multicenter, double-blind, placebo-controlled trial. From July 2017 to November 2019, patients with HF (regardless of ejection fraction, with or without type 2 diabetes) and previously implanted pulmonary artery (PA) pressure sensor (CardioMEMS) were randomized across 10 US centers to empagliflozin 10 mg daily or placebo and treated for 12 weeks. The primary end point was change in PA diastolic pressure (PADP) from baseline to end of treatment (average PADP weeks 8-12). Secondary end points included health status (Kansas City Cardiomyopathy Questionnaire score), natriuretic peptides, and 6-min walking distance. RESULTS: Overall, 93 patients were screened, and 65 were randomized (33 to empagliflozin, 32 to placebo). The mean age was 66 years; 63% were male; 52% had type 2 diabetes; 54% were in New York Heart Association class III/IV; mean ejection fraction was 44%; median NT-proBNP (N-terminal pro B-type natriuretic peptide) was 637 pg/mL; and mean PADP was 22 mm Hg. Empagliflozin significantly reduced PADP, with effects that began at week 1 and amplified over time; average PADP (weeks 8-12) was 1.5 mm Hg lower (95% CI, 0.2-2.8; P=0.02); and at week 12, PADP was 1.7 mm Hg lower (95% CI, 0.3-3.2; P=0.02) with empagliflozin versus placebo. Results were consistent for PA systolic and PA mean pressures. There was no difference in mean loop diuretic management (daily furosemide equivalents) between treatment groups. No significant differences between treatment groups were observed in Kansas City Cardiomyopathy Questionnaire scores, natriuretic peptide levels, and 6-min walking distance. CONCLUSIONS: In patients with HF and CardioMEMS PA pressure sensor, empagliflozin produced rapid reductions in PA pressures that were amplified over time and appeared to be independent of loop diuretic management. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03030222.

Lower Rates of Heart Failure and All-Cause Hospitalizations During Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure: One-Year Outcomes From the CardioMEMS Post-Approval Study.

BACKGROUND: Ambulatory hemodynamic monitoring with an implantable pulmonary artery (PA) sensor is approved for patients with New York Heart Association Class III heart failure (HF) and a prior HF hospitalization (HFH) within 12 months. The objective of this study was to assess the efficacy and safety of PA pressure-guided therapy in routine clinical practice with special focus on subgroups defined by sex, race, and ejection fraction. METHODS: This multi-center, prospective, open-label, observational, single-arm trial of 1200 patients across 104 centers within the United States with New York Heart Association class III HF and a prior HFH within 12 months evaluated patients undergoing PA pressure sensor implantation between September 1, 2014, and October 11, 2017. The primary efficacy outcome was the difference between rates of adjudicated HFH 1 year after compared with the 1 year before sensor implantation. Safety end points were freedom from device- or system-related complications at 2 years and freedom from pressure sensor failure at 2 years. RESULTS: Mean age for the population was 69 years, 37.7% were women, 17.2% were non-White, and 46.8% had preserved ejection fraction. During the year after sensor implantation, the mean rate of daily pressure transmission was 76±24% and PA pressures declined significantly. The rate of HFH was significantly lower at 1 year compared with the year before implantation (0.54 versus 1.25 events/patient-years, hazard ratio 0.43 [95% CI, 0.39-0.47], P<0.0001). The rate of all-cause hospitalization was also lower following sensor implantation (1.67 versus 2.28 events/patient-years, hazard ratio 0.73 [95% CI, 0.68-0.78], P<0.0001). Results were consistent across subgroups defined by ejection fraction, sex, race, cause of cardiomyopathy, presence/absence of implantable cardiac defibrillator or cardiac resynchronization therapy and ejection fraction. Freedom from device- or system-related complications was 99.6%, and freedom from pressure sensor failure was 99.9% at 1 year. CONCLUSIONS: In routine clinical practice as in clinical trials, PA pressure-guided therapy for HF was associated with lower PA pressures, lower rates of HFH and all-cause hospitalization, and low rates of adverse events across a broad range of patients with symptomatic HF and prior HFH. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02279888.

Ambulatory Hemodynamic Monitoring Reduces Heart Failure Hospitalizations in "Real-World" Clinical Practice.

BACKGROUND: In the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association [NYHA] Functional Class III Heart Failure Patients) trial, heart failure hospitalization (HFH) rates were lower in patients managed with guidance from an implantable pulmonary artery pressure sensor compared with usual care. OBJECTIVES: This study examined the effectiveness of ambulatory hemodynamic monitoring in reducing HFH outside of the clinical trial setting. METHODS: We conducted a retrospective cohort study using U.S. Medicare claims data from patients undergoing pulmonary artery pressure sensor implantation between June 1, 2014, and December 31, 2015. Rates of HFH during pre-defined periods before and after implantation were compared using the Andersen-Gill extension to the Cox proportional hazards model while accounting for the competing risk of death, ventricular assist device implantation, or cardiac transplantation. Comprehensive heart failure (HF)-related costs were compared over the same periods. RESULTS: Among 1,114 patients receiving implants, there were 1,020 HFHs in the 6 months before, compared with 381 HFHs, 139 deaths, and 17 ventricular assist device implantations and/or transplants in the 6 months after implantation (hazard ratio [HR]: 0.55; 95% confidence interval [CI]: 0.49 to 0.61; p < 0.001). This lower rate of HFH was associated with a 6-month comprehensive HF cost reduction of $7,433 per patient (IQR: $7,000 to $7,884), and was robust in analyses restricted to 6-month survivors. Similar reductions in HFH and costs were noted in the subset of 480 patients with complete data available for 12 months before and after implantation (HR: 0.66; 95% CI: 0.57 to 0.76; p < 0.001). CONCLUSIONS: As in clinical trials, use of ambulatory hemodynamic monitoring in clinical practice is associated with lower HFH and comprehensive HF costs. These benefits are sustained to 1 year and support the "real-world" effectiveness of this approach to HF management.

A regional system for delivery of primary percutaneous coronary intervention in ST-elevation myocardial infarction: STEMI-St. Cloud.

BACKGROUND: Strategies of emergency care in the treatment of ST-segment elevation myocardial infarction (STEMI) have evolved rapidly over the past two decades to include primary percutaneous coronary intervention (PPCI) when possible. Most U.S.-based transfer programs still use complicated protocols that include fibrinolytic therapy often resulting in transfer delays, inappropriately applied therapy (wrong diagnosis) and bleeding and stroke complications. These protocols are often emphasized in low-volume centers. We implemented a program absent fibrinolytic therapy and applied it to a network of 25 participating hospitals over a 100-mile radius in central Minnesota. METHODS AND RESULTS: One-thousand consecutive patients ages 21 to 90 who presented within 12 hours of the onset of symptoms consistent with MI from April, 2004 to January, 2008 were included in this registry. Prior to transfer to the cardiac catheterization laboratory, patients received aspirin and heparin. Clopidogrel was added to the protocol in January, 2007. Glycoprotein (GP) IIb/IIIa inhibitors were typically utilized after diagnostic catheterization and prior to PPCI. Median door-to-balloon time was 56 minutes at the PCI Center and 110 minutes from referral sites (RS). Of the transfer patients, 71% underwent helicopter transfer. The success rate for PPCI was 99.4%. Despite inherent transfer delays, there was no difference in mortality between the PCI Center and RS. Overall mortality rates in-hospital, at 30 days, at 6 months, and 1 year were 2.1%, 2.9%, 3.8% and 4.5%, respectively, with follow up on 998 of 1,000 patients. In-hospital stroke, reinfarction and major bleeding were 0.7%, 2.0% and 2.7%, respectively. CONCLUSIONS: Despite increasing trends toward a pharmacoinvasive approach in transfer patients with STEMI, a protocol which stresses rapid transfer and PPCI results in excellent outcomes, with very low complication rates without fibrinolytic therapy.

International heterogeneity in diagnostic frequency and clinical outcomes of ascending aortic intramural hematoma.

BACKGROUND: Differing diagnostic frequencies and management strategies for intramural hematoma (IMH) have been described in North American (NA)/European and Japanese/Korean studies. METHODS: All publications including type-A aortic IMH were reviewed for details on patient demographics, treatment strategy, and clinical outcomes. Publications were stratified by the geographic region (NA/Europe or Japan/Korea). RESULTS: IMH, as a percentage of aortic dissection, occurs more frequently in Japan/Korea versus NA/Europe (31.7% vs 10.9%, P < .0001). The proportion of patients treated with early medical therapy is greater in Japanese/Korean studies (77.9% vs 48.8% in NA/Europe, P < .0001). However, the overall mortality is significantly lower in Japan/Korea compared with NA/Europe (9.4% vs 20.6%, odds ratio = 2.80, P = .003) in part because of the lower mortality with early medical therapy (7.8% vs 33.3%, P < .0001). CONCLUSION: There is significant international heterogeneity in the diagnosis and clinical outcomes of ascending IMH. IMH is diagnosed more frequently and has better overall outcomes in Japan/Korea.

Clinical utility of coronary CT angiography: coronary stenosis detection and prognosis in ambulatory patients.

INTRODUCTION: Multislice CT coronary angiography (MSCTA) accurately detects stenosis in patients undergoing coronary arteriography, but its accuracy in clinical outpatients is less certain. This study retrospectively analyzed MSCTA performance in a large outpatient cohort and examined 6-month clinical follow-up in those without invasive CA. METHODS: Patients underwent MSCTA for clinical indications including symptoms or noninvasive results being either equivocal or suspected as incorrect by referring clinicians. Standard 16-slice CT scanner techniques were used, and results were analyzed on the basis of both patient and vessel. Patients were treated medically or sent to invasive angiography on the basis of MSCTA results and judgment of referring clinicians. All invasive angiograms were analyzed using quantitative coronary angiography. Six-month clinical follow-up was determined in patients without CA. RESULTS: One thousand fifty-three consecutive patients were referred for MSCTA, resulting in 994 interpretable scans. Mean age was 58+/-13 years, 55% were male, 50% had prior noninvasive testing, and 90% had symptoms. Invasive angiography was performed in 160 patients, with significant stenoses present in 69%. MSCTA demonstrated 87% and 89% accuracy by patient- and vessel-based analysis, respectively, and was most accurate in the left main and right coronary arteries. Only two patients not referred for angiography had significant stenosis in those undergoing 6-month follow-up. CONCLUSIONS: MSCTA accurately detects obstructive coronary stenosis in clinical patients with possible cardiac symptoms, and effectively triages them for invasive angiography. Negative results are highly accurate in ruling out obstructive disease. Six-month prognosis is excellent in patients without significant disease determined by MSCT.

Patent foramen ovale: standards for a preclinical model of prevalence, structure, and histopathologic comparability to human hearts.

BACKGROUND: This study evaluated and standardized a Patent Foramen Ovale (PFO) preclinical model in gross anatomic and histopathologic features. METHODS: We examined 150 necropsy-derived domestic porcine hearts, age 4-6 months for PFO prevalence, appearance, and size. Histopathologic preparations were standardized and processed identically to 24 post-mortem human hearts aged 16-62 years. A measurement scheme was developed for PFO atrial openings, tunnel length, and histopathologic features to compare porcine and patient hearts. RESULTS: PFO was found in 32 of the 150 porcine hearts (prevalence 21.3%). Twenty-five porcine PFO underwent standard characterization by tunnel length, and right, and left atrial orifice diameters. Logarithmic regression analysis between porcine PFO tunnel length and left atrial orifice area demonstrated a significant positive relationship (P = 0.0162, R(2) = 0.227). The porcine PFO tunnel length was significantly longer than in humans (12.0 +/- 4.0 mm vs. 7.1 +/- 3.1 mm respectively, P < 0.0001). Histopathologic comparison was made using serial sections perpendicular to the atrial septum and the tunnel long axis. Human and porcine PFO lesions demonstrated strong similarities in tissue cells, connective tissue, and matrix composition. CONCLUSIONS: PFO assessment was standardized in both macroscopically and histopathologically, with quantitative and qualitative comparisons feasible using a porcine preclinical model. PFO prevalence in domestic swine is identical to humans, and microscopic structures very similar to humans. The domestic swine PFO model appears useful to evaluate new interventional closure technologies due to comparability in microscopic features. Tunnel length should be carefully evaluated due to differences across pigs and patients.