Jeffrey A. Southard

Randomized, Controlled Trial to Improve Self-Care in Patients With Heart Failure Living in Rural Areas

Background— Patients with heart failure (HF) who live in rural areas have less access to cardiac services than patients in urban areas. We conducted a randomized, clinical trial to determine the impact of an educational intervention on the composite end point of HF rehospitalization and cardiac death in this population. Methods and Results— Patients (n=602; age, 66±13 years; 41% female; 51% with systolic HF) were randomized to 1 of 3 groups: control (usual care), Fluid Watchers LITE, or Fluid Watchers PLUS. Both intervention groups included a face-to-face education session delivered by a nurse focusing on self-care. The LITE group received 2 follow-up phone calls, whereas the PLUS group received biweekly calls (mean, 5.3±3.6; range, 1–19) until the nurse judged the patient to be adequately trained. Over 2 years of follow-up, 35% of patients (n=211) experienced cardiac death or hospitalization for HF, with no difference among the 3 groups in the proportion who experienced the combined clinical outcome (P=0.06). Although patients in the LITE group had reduced cardiac mortality compared with patients in the control group over the 2 years of follow-up (7.5% and 17.7%, respectively; P=0.003), there was no significant difference in cardiac mortality between patients in the PLUS group and the control group. Conclusions— A face-to-face education intervention did not significantly decrease the combined end point of cardiac death or hospitalization for HF. Increasing the number of contacts between the patient and nurse did not significantly improve outcome. Clinical Trial Registration— http://www.clinicaltrials.gov. Unique identifier: NCT00415545.

Personalized Telehealth in the Future: A Global Research Agenda

As telehealth plays an even greater role in global health care delivery, it will be increasingly important to develop a strong evidence base of successful, innovative telehealth solutions that can lead to scalable and sustainable telehealth programs. This paper has two aims: (1) to describe the challenges of promoting telehealth implementation to advance adoption and (2) to present a global research agenda for personalized telehealth within chronic disease management. Using evidence from the United States and the European Union, this paper provides a global overview of the current state of telehealth services and benefits, presents fundamental principles that must be addressed to advance the status quo, and provides a framework for current and future research initiatives within telehealth for personalized care, treatment, and prevention. A broad, multinational research agenda can provide a uniform framework for identifying and rapidly replicating best practices, while concurrently fostering global collaboration in the development and rigorous testing of new and emerging telehealth technologies. In this paper, the members of the Transatlantic Telehealth Research Network offer a 12-point research agenda for future telehealth applications within chronic disease management.

Dynamic tissue analysis using time- and wavelength-resolved fluorescence spectroscopy for atherosclerosis diagnosis

Simultaneous time- and wavelength-resolved fluorescence spectroscopy (STWRFS) was developed and tested for the dynamic characterization of atherosclerotic tissue ex vivo and arterial vessels in vivo. Autofluorescence, induced by a 337 nm, 700 ps pulsed laser, was split to three wavelength sub-bands using dichroic filters, with each sub-band coupled into a different length of optical fiber for temporal separation. STWRFS allows for fast recording/analysis (few microseconds) of time-resolved fluorescence emission in these sub-bands and rapid scanning. Distinct compositions of excised human atherosclerotic aorta were clearly discriminated over scanning lengths of several centimeters based on fluorescence lifetime and the intensity ratio between 390 and 452 nm. Operation of STWRFS blood flow was further validated in pig femoral arteries in vivo using a single-fiber probe integrated with an ultrasound imaging catheter. Current results demonstrate the potential of STWRFS as a tool for real-time optical characterization of arterial tissue composition and for atherosclerosis research and diagnosis.

Multispectral fluorescence lifetime imaging system for intravascular diagnostics with ultrasound guidance: in vivo validation in swine arteries

Fluorescence lifetime technique has demonstrated potential for analysis of atherosclerotic lesions and for complementing existing intravascular imaging modalities such as intravascular ultrasound (IVUS) in identifying lesions at high risk of rupture. This study presents a multimodal catheter system integrating a 40 MHz commercial IVUS and fluorescence lifetime imaging (FLIm) using fast helical motion scanning (400 rpm, 0.75 mm/s), able to acquire in vivo in pulsatile blood flow the autofluorescence emission of arterial vessels with high precision (5.08 ± 0.26 ns mean average lifetime over 13 scans). Co-registered FLIm and IVUS data allowed 3D visualization of both biochemical and morphological vessel properties. Current study supports the development of clinically compatible intravascular diagnostic system integrating FLIm and demonstrates, to our knowledge, the first in vivo intravascular application of a fluorescence lifetime imaging technique.

Transradial and transfemoral coronary angiography and interventions: 1-Year outcomes after initiating the transradial approach in a cardiology training program

BACKGROUND Limited data are available regarding the safety and feasibility of initiating transradial (TR) diagnostic coronary angiography (CA) and percutaneous coronary intervention (PCI) in cardiology fellowship programs. METHODS From July 2010 to June 2011, University of California, Davis Medical Center, adopted the TR approach with supervised cardiology fellows as the primary operators. Procedural variables and clinical outcomes of TR and transfemoral (TF) procedures were compared. To minimize confounding variables, ST-elevation myocardial infarction, bypass graft interventions, chronic total occlusions, and procedures with concomitant right heart catheterizations were excluded. To reflect the learning curve of the TR approach, this experience was assessed in 2 sequential 6-month periods. RESULTS A total of 402 diagnostic CAs and 255 PCIs were included. Transradial access was used in 141 (35%) of the CAs and in 72 (28%) of PCIs. Within the TR-CA and TF-CA (n = 261) groups, there was no difference between fluoroscopy (10.4 ± 6.0 vs 11.0 ± 8.9, P = .63) or procedure (31.8 ± 11.5 vs 33.2 ± 13.8, P = .55) time throughout the academic year with a significant trend toward lower contrast use (128 ± 52 vs 110 vs 50, P = .04) by the second half. In addition, during the second half of the academic year, the TR-CA showed significantly higher fluoroscopy (11.0 ± 8.9 vs 6.7 ± 6.8, P = .001) and procedure (33.2 ± 13.8 vs 27.2 ± 11.6, P = .0015) times when compared with TF-CA. Transfemoral PCI (n = 183) and TR-PCI showed no significant difference between all fluoroscopy and procedure time and contrast use when comparing the 2 halves of the academic year. When comparing TF with TR within each academic half year, there was no difference within the PCI group. Vascular complications were less with the TR approach. Overall procedural success rates were high, and there were low rates of crossover and periprocedural complications in both the TR and the TF groups. CONCLUSION A TR approach is safe for CA and PCI when performed by supervised operators in training. Although the learning curve for trainees appears slower for TR-CA compared with TF-CA, cardiology fellowship training programs should be encouraged to adopt TR procedures as part of their curriculum.

Correlates of Quality of Life in Rural Patients With Heart Failure

Background—There is abundant research indicating poor physical, psychological, and social functioning of patients with chronic heart failure (HF), a reality that can lead to poor health-related quality of life (QoL). Little is known about the experience of rural patients with HF. Methods and Results—This study was part of a randomized clinical trial titled Rural Education to Improve Outcomes in Heart Failure (REMOTE-HF) designed to test an education and counseling intervention to improve self-care in patients with HF. We evaluated 612 rural patients. Multiple validated questionnaires were administered to assess patient perceptions of health and health literacy. Baseline factors were collected and compared with baseline QoL measures only. Patients’ health-related QoL was assessed using the Minnesota Living with Heart Failure scale. The data were analyzed using a general linear model to test the association of various patient characteristics with QoL in rural patients with HF. Patients were 65.8 (+12.9) years of age. The majority were men (58.7%), married (56.4%), and had completed a high-school education (80.9%). Factors associated with reduced QoL among this population include geographic location, younger age, male sex, higher New York Heart Association class, worse HF knowledge, poorer perceived control, and symptoms of depression or anxiety. The data provided no evidence of an association between left ventricular ejection fraction and QoL. Conclusions—This study of rural patients with HF confirms previously identified factors associated with perceptions of QoL. However, further study is warranted with an urban control group. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00415545.

Rural Patients' Knowledge About Heart Failure

Background:Heart failure (HF) is a potentially disabling condition requiring significant patient knowledge to manage the requirements of self-care. The need for self-care is important for all patients but particularly for those living in rural areas that are geographically remote from healthcare services. Objective:The aim of this study was to identify the level of knowledge of rural patients with HF and the clinical and demographic characteristics associated with low levels of HF knowledge. Methods:Baseline data from 612 patients with HF enrolled in the Rural Education to Improve Outcomes in Heart Failure trial were analyzed using the Heart Failure Knowledge Scale, the Short Test of Functional Health Literacy in Adults, and the anxiety subscale of the Brief Symptom Inventory. Multiple linear regression was used to explore the contribution of sociodemographic and clinical variables to levels of HF knowledge. Results:The mean (SD) age was 66 (13) years; 59% were men, and 50.5% had an ejection fraction of less than 40%. The mean (SD) percent correct on the Heart Failure Knowledge Scale was 69.5% (13%; range, 25%–100%), with the most frequent incorrect items related to symptoms of HF and the need for daily weights. The men and the older patients scored significantly lower in HF knowledge than did the women and the younger patients (P = 0.002 and 0.011, respectively). The patients with preserved systolic function also scored significantly lower than those with systolic HF (P = 0.030). Conclusions:Patients who are at risk for poor self-care because of low levels of HF knowledge can be identified. Older patients, men, and, patients with HF with preserved systolic function may require special educational strategies to gain the knowledge required for effective self-care.

Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta‐analysis of randomized primary percutaneous coronary intervention trials

The relative safety of drug‐eluting stents (DES) and bare‐metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long‐term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta‐analysis were compared. Methods: Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta‐analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials. Results: Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39–0.89), MI (OR 0.59, 95% CI 0.39–0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31–0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34–0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non‐significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60–1.14), OR 0.88, 95% CI (0.6–1.28)] with the use of second generation DES versus BMS at 3 years. Conclusions: Network meta‐analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS.

In Search of the False‐negative Exercise Treadmill Testing Evidence‐based Use of Exercise Echocardiography

Controversy exists regarding the role of exercise treadmill testing (ETT) versus exercise stress echocardiography (ESE) as the appropriate initial noninvasive test to risk‐stratify patients with chest pain. The majority of studies to date that evaluated these methodologies included patients with poor functional status and baseline electrocardiogram (ECG) abnormalities, potentially limiting the sensitivity of ETT.

Factors associated with telemonitoring use among patients with chronic heart failure

Background In adults with chronic heart failure (HF; defined as people with previously diagnosed left ventricular dysfunction) telemonitoring randomized controlled trials (RCTs) failed to consistently demonstrate improved clinical outcomes. We aimed to examine if patient and HF characteristics are associated with device preferences and use. Methods Using a cross-sectional, multicenter, international design, ambulatory and hospitalized adults with HF in Ohio, California, and Denmark viewed a six-minute video of telemonitoring configurations (tablet, smart phone, and key fob) and completed questionnaires. Comparative analyses were performed and when significant, pairwise comparisons were performed using Bonferroni-adjusted significance levels. Results Of 206 participants, 48.2% preferred smart phones for telemonitoring, especially when traveling (54.8%), with new/worsening symptoms (50%), for everyday use (50%), and connecting with doctors (48.5%). Participants preferred two-way communication and a screen with words over voice or number pads. Of device purposes, allowing for nurse communication ranked highest, followed by maintaining overall health. Very few patient and HF factors were associated with device preferences. Patients with higher health literacy (p = 0.007), previous/current device use history (p = 0.008), higher education level (p = 0.035), and married/cohabitating status (p = 0.023) had higher perceptions of ease of using devices. Those who were asymptomatic or had mild HF had higher self-confidence for health devices (p = 0.024) and non-white patients perceived devices as more useful (p = 0.033). Conclusion Telemonitoring use may be enhanced by simple plug-and-play type devices, two-way communication, and features that meet patients’ personal learning and use needs.